Rheumatoid Arthritis
Conditions
Keywords
E6011, rheumatoid arthritis
Brief summary
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to biologics.
Interventions
DRUGE6011
subcutaneous administration
DRUGPlacebo
subcutaneous administration
Sponsors
Eisai Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 and \<75 years old at the time of informed consent * Diagnosed with rheumatoid arthritis (RA) under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria ≥12 weeks before informed consent * Received biologics treatment under approved dosage and administration for ≥12 weeks but discontinued it before screening because of inadequate response * History of biologics treatment should be limited to 2 agents among adalimumab, infliximab, golimumab, certolizumab pegol, etanercept, tocilizumab, and abatacept (including biosimilars) * Presented ≥6 tender joints (out of 68 joints) and ≥6 swollen joints (out of 66 joints) in the Screening and Observation Phases * Can continue stable dose regimen of methotrexate at 6 to 16 milligrams (mg)/week from 4 weeks before starting the study treatment until completion of the Extension Phase (or until study discontinuation) * C-reactive protein (CRP) level ≥0.6 mg/deciliter (dL) or erythrocyte sedimentation rate (ESR) ≥28 millimeters per hour (mm/hr) in the Screening Phase * Weighs ≥30 kilograms (kg) and ≤100 kg in the Screening Phase * Has voluntarily consented, in writing, to participate in this study. If a participant is below the age of 20, also consented, in writing by a legally acceptable representative * Has been thoroughly briefed on the conditions for participation in the study, is able to understand, and is willing and able to comply with all aspects of the protocol
Exclusion criteria
* Any history or complication of inflammatory arthritic disorder other than RA or Sjogren's syndrome * Meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class IV in the Screening Phase * Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment * Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive * Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participant's safety or interfere with the study assessments in the opinion of the investigator or subinvestigator * Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage * History of severe allergy (shock or anaphylactoid symptoms) * History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent * Immunodeficiency or history of human immunodeficiency virus (HIV) infection * Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (e.g., herpes zoster) within 4 weeks before starting the study treatment * History of tuberculosis or current complication of active tuberculosis * History of clinically important vasculitis * Tested positive for any of the following in the Screening Phase: HIV, hepatitis B virus surface antigen (HBs antigen), hepatitis B virus surface antibody (HBs antibody), hepatitis B virus core antibody (HBc antibody), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus antibody (HCV antibody), human T-lymphotrophic virus Type I antibody (HTLV-1 antibody), or syphilis * Positive in tuberculosis test (QuantiFERON Tuberculosis Gold Test or T-SPOT Tuberculosis Test) in the Screening Phase * Findings indicating a history of tuberculosis on chest x-ray in the Screening Phase * Neurological findings such as paralysis, visual impairment, or language disorder in the Screening Phase * Demonstrated prolonged QTcF (Fridericia's Correction Formula) interval (\>450 milliseconds \[ms\]) in repeated electrocardiogram examinations * Females of childbearing potential who have a positive pregnancy test in the Screening or Observation Phase or are breastfeeding * Females of childbearing potential who: * Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method \[such as condom plus diaphragm with spermicide\], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period or for 28 days after study drug discontinuation * Are currently abstinent, and do not agree to use a double-barrier method (as described above) or refrain from being sexually active during the study period or for 28 days after study drug discontinuation * Are using hormonal contraceptives but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study or for 28 days after study drug discontinuation. (NOTE: All females will be considered to be of childbearing potential unless they are postmenopausal \[amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause\] or have been sterilized surgically \[i.e., bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing\]). * Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period or for 28 days after study drug discontinuation). No sperm donation is allowed during the study period or for 28 days after study drug discontinuation. * Scheduled for surgery during the study * Currently enrolled in another clinical study or used any investigational drug or device within 28 days (or 5× the half-life, whichever is longer) before informed consent * Has been treated with E6011 or any biologics for use in RA that has not been approved * Use of a psychotropic agent as recreational purpose other than therapeutic purpose * Any history of a medical condition or a concomitant medical condition that in the opinion of the investigator or subinvestigator would compromise the participant's ability to safely complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI) | Week 12 | The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (\>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); \>=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale \[VAS\]), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The ACR50 response was defined as if the following 3 criteria (ACR components) were met: \>=50% reduction from baseline in the TJC in 68 joints (TJC68); \>=50% reduction from baseline in the SJC in 66 joints (SJC66); \>=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The ACR70 response was defined as if the following 3 criteria (ACR components) were met: \>=70% reduction from baseline in the TJC in 68 joints (TJC68); \>=70% reduction from baseline in the SJC in 66 joints (SJC66); \>=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | A total of 28 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | A total of 28 joints were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. Pain assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | Degree of disability was self-evaluated by participant using HAQ-DI.Assessment was made based on activities capable without any aids/devices.20-question instrument assessed degree of difficulty person had in accomplishing tasks in 8 functional areas(dressing,arising,eating,walking,hygiene,reaching,gripping,and activities of daily living).Responses in each functional area were scored from 0(indicated no difficulty)to 3(indicated inability to perform task in that area).Overall score computed as: sum of domain scores and divided by number of domains answered.Total possible score range:0-3 where 0=least difficulty and 3=extreme difficulty.Data for Core Treatment Phase from Week 0-10 is reported according to participant re-randomization in 4 arms at Week 12.Data reported for Extension Phase from Baseline to Week 24,is same data for Core Treatment Phase,but excluding participants who received at least 1 dose of drug and had at least 1 postdose primary efficacy measurement after Week 24-72. |
| Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | CRP of each participants was measured as a part of blood biochemical tests. A normal CRP value is less than (\<) 10 milligram per deciliter (mg/dL). A test result showing a CRP level greater than 10 mg/dL is a sign of chronic disease. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 16, 20, 24; Extension Phase: Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The ACR20 response was defined as if the following 3 criteria (ACR components) were met: \>=20% reduction from baseline in the TJC in 68 joints (TJC68); \>=20% reduction from baseline in the SJC in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above=high disease activity, a value greater than (\>) 3.2 and less than or equal to (\<=) 5.1=moderate disease activity and value \<=3.2=low disease activity, value \<2.6=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 4.1 or above=high disease activity, a value \>2.7 and \<=4.1=moderate disease activity and a value \<=2.7=low disease activity, value \<2.3=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 26 or above=high disease activity, a value \>11 and \<=26=moderate disease activity and value \<=11=low disease activity, value \<=3.3=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10) and physician global assessment of disease activity (score range as 0-10). Total score ranged between 0-76. CDAI score of 22 or above=high disease activity, a value \>10 and \<=22=moderate disease activity, a value \<=10=low disease activity, and a value \<=2.8=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The Disease Activity Score Based on 28-joints Count-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \<=5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The Disease Activity Score Based on 28-joints Count-CRP based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \<=5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 86 or above=high disease activity, a value \>11 and \<=26=moderate disease activity, a value \>=3.4 and \<=11=low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score \<=3.3. Data for Core Treatment Phase from Week 0-10 is reported according to participant's re-randomization in four arms at Week 12. Data reported for Extension Phase from Week 2 to Week 24, is same data for Core Treatment Phase, but excluding participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), and physician global assessment of disease activity score (score range as 0-10). Total score ranged between 0-76. CDAI score of 76 or above=high disease activity, a value \>10 and \<=22=moderate disease activity, a value \>2.9 and \<=10=low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score \<=2.8. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | Boolean remission criteria was defined as: tender joint count 68 \<=1; swollen joint count 66 \<=1; CRP \<=1 mg/dL; and disease activity assessments VAS (mm) by participants \<=10. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 | ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 46 investigative sites in Japan from 26 November 2016 to 25 November 2019.
Pre-assignment details
A total of 93 participants were screened, of which 66 were randomized to receive study treatment. This study has a Core Treatment Phase (Treatment Phase: 12 Weeks; Entire Treatment Phase \[Re-randomized Participants\]: 12 Weeks) and an Extension Phase: 80 Weeks.
Participants by arm
| Arm | Count |
|---|---|
| Core Treatment Phase: Placebo During the Core Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (Placebo) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase. | 33 |
| Core Treatment Phase: E6011 400 mg During the Core Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 10. Participants who continued the study beyond Week 12 in the Core Treatment Phase (E6011 400 mg) received E6011 200 mg or 400 mg, infusion, subcutaneously every 2 weeks between weeks 12 and 22. Participants who completed evaluations at Week 24 of the Core Treatment Phase entered the Extension Phase. | 31 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Extension Phase(Open-label): 80 Weeks | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 0 |
| Extension Phase(Open-label): 80 Weeks | Disease Progression | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
| Extension Phase(Open-label): 80 Weeks | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 3 | 3 | 7 |
| Extension Phase(Open-label): 80 Weeks | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Extension Phase(Open-label): 80 Weeks | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Re-randomized Participants: 12 Weeks | Adverse Event | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Re-randomized Participants: 12 Weeks | Lack of Efficacy | 0 | 0 | 1 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| Re-randomized Participants: 12 Weeks | Other | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Phase(Double-blind): 12 Weeks | Adverse Event | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Phase(Double-blind): 12 Weeks | Disease Progression | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Phase(Double-blind): 12 Weeks | Lack of Efficacy | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Phase(Double-blind): 12 Weeks | Not treated | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Core Treatment Phase: Placebo | Core Treatment Phase: E6011 400 mg | Total |
|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 10.64 | 53.5 years STANDARD_DEVIATION 11.3 | 51.5 years STANDARD_DEVIATION 11.05 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants | 31 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Japanese | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Female | 28 Participants | 22 Participants | 50 Participants |
| Sex: Female, Male Male | 5 Participants | 9 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 31 | 0 / 15 | 0 / 14 | 0 / 14 | 0 / 12 | 1 / 13 | 0 / 11 | 0 / 13 | 0 / 10 |
| other Total, other adverse events | 19 / 33 | 14 / 31 | 12 / 15 | 13 / 14 | 13 / 14 | 9 / 12 | 13 / 13 | 11 / 11 | 13 / 13 | 9 / 10 |
| serious Total, serious adverse events | 1 / 33 | 0 / 31 | 0 / 15 | 1 / 14 | 0 / 14 | 0 / 12 | 2 / 13 | 2 / 11 | 2 / 13 | 0 / 10 |
Outcome results
Primary
Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI)
The ACR20 response was defined as if the following 3 criteria (ACR components) were met: Greater than or equal to (\>=) 20 percent (%) reduction from baseline in the tender joint count (TJC) in 68 joints (TJC68); \>=20% reduction from baseline in the swollen joint count (SJC) in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (visual analog scale \[VAS\]), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), Health Assessment Questionnaire disability index (HAQ-DI), and C-reactive protein (CRP).
Time frame: Week 12
Population: FAS included all randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Core Treatment Phase: Placebo | Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI) | 27.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Core Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 12 Based on Non-responder Imputation (NRI) | 22.6 percentage of participants |
p-value: 0.62195% CI: [-25.85, 16.46]Regression, Logistic
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF
The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10) and physician global assessment of disease activity (score range as 0-10). Total score ranged between 0-76. CDAI score of 22 or above=high disease activity, a value \>10 and \<=22=moderate disease activity, a value \<=10=low disease activity, and a value \<=2.8=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 28.687 score on a scale | Standard Deviation 13.279 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.087 score on a scale | Standard Deviation 7.287 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -12.360 score on a scale | Standard Deviation 13.3098 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -7.947 score on a scale | Standard Deviation 9.5817 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -14.320 score on a scale | Standard Deviation 12.8371 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -10.200 score on a scale | Standard Deviation 9.0094 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.807 score on a scale | Standard Deviation 12.8912 |
| Core Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -8.653 score on a scale | Standard Deviation 11.3262 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.593 score on a scale | Standard Deviation 11.0959 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -12.279 score on a scale | Standard Deviation 11.3618 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.986 score on a scale | Standard Deviation 17.5102 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -10.807 score on a scale | Standard Deviation 18.0182 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.629 score on a scale | Standard Deviation 6.607 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -13.129 score on a scale | Standard Deviation 14.0345 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -11.779 score on a scale | Standard Deviation 16.9787 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 32.486 score on a scale | Standard Deviation 15.489 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 30.657 score on a scale | Standard Deviation 9.4928 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -6.586 score on a scale | Standard Deviation 12.2036 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -6.679 score on a scale | Standard Deviation 14.8931 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.714 score on a scale | Standard Deviation 12.965 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -7.400 score on a scale | Standard Deviation 14.5217 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -5.493 score on a scale | Standard Deviation 13.6155 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.714 score on a scale | Standard Deviation 9.0823 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -8.600 score on a scale | Standard Deviation 13.6702 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -13.192 score on a scale | Standard Deviation 8.63 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 32.833 score on a scale | Standard Deviation 12.8294 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -13.433 score on a scale | Standard Deviation 5.8262 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -10.400 score on a scale | Standard Deviation 6.4684 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -13.983 score on a scale | Standard Deviation 12.3963 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -15.550 score on a scale | Standard Deviation 11.7076 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -17.592 score on a scale | Standard Deviation 12.6565 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -8.942 score on a scale | Standard Deviation 8.1025 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -10.300 score on a scale | Standard Deviation 12.7026 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -15.331 score on a scale | Standard Deviation 13.5575 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -10.823 score on a scale | Standard Deviation 13.4309 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -14.123 score on a scale | Standard Deviation 14.671 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -12.646 score on a scale | Standard Deviation 14.831 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -12.354 score on a scale | Standard Deviation 16.1397 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -12.192 score on a scale | Standard Deviation 14.5243 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -13.377 score on a scale | Standard Deviation 14.4734 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -10.415 score on a scale | Standard Deviation 13.43 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -9.785 score on a scale | Standard Deviation 12.9341 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -9.300 score on a scale | Standard Deviation 12.3597 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -8.292 score on a scale | Standard Deviation 10.1373 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -10.523 score on a scale | Standard Deviation 12.9377 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -12.677 score on a scale | Standard Deviation 14.3445 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.515 score on a scale | Standard Deviation 7.7685 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.438 score on a scale | Standard Deviation 11.8829 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.985 score on a scale | Standard Deviation 13.8258 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -10.077 score on a scale | Standard Deviation 9.6871 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -13.069 score on a scale | Standard Deviation 14.2281 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 27.492 score on a scale | Standard Deviation 11.0621 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.373 score on a scale | Standard Deviation 11.9883 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -15.282 score on a scale | Standard Deviation 20.3093 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -14.936 score on a scale | Standard Deviation 21.9162 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -10.927 score on a scale | Standard Deviation 17.8324 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -15.327 score on a scale | Standard Deviation 21.3345 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -11.955 score on a scale | Standard Deviation 15.8809 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -9.527 score on a scale | Standard Deviation 14.8393 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -13.245 score on a scale | Standard Deviation 19.5791 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.645 score on a scale | Standard Deviation 19.0353 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -13.709 score on a scale | Standard Deviation 12.4778 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -14.864 score on a scale | Standard Deviation 15.4843 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -13.255 score on a scale | Standard Deviation 19.0433 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -13.964 score on a scale | Standard Deviation 20.1448 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -11.945 score on a scale | Standard Deviation 18.0326 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -14.755 score on a scale | Standard Deviation 19.2637 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -14.200 score on a scale | Standard Deviation 18.3184 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -14.891 score on a scale | Standard Deviation 19.243 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 31.918 score on a scale | Standard Deviation 17.1251 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.100 score on a scale | Standard Deviation 7.3778 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -11.845 score on a scale | Standard Deviation 20.2785 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -9.208 score on a scale | Standard Deviation 18.0779 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -10.046 score on a scale | Standard Deviation 19.5472 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 29.969 score on a scale | Standard Deviation 9.5103 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -8.785 score on a scale | Standard Deviation 18.0594 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -9.962 score on a scale | Standard Deviation 19.4745 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -7.954 score on a scale | Standard Deviation 18.5732 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -6.092 score on a scale | Standard Deviation 12.5557 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -6.862 score on a scale | Standard Deviation 15.4849 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -8.354 score on a scale | Standard Deviation 14.1961 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -9.877 score on a scale | Standard Deviation 18.6515 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -7.585 score on a scale | Standard Deviation 17.9281 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -8.138 score on a scale | Standard Deviation 17.615 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.831 score on a scale | Standard Deviation 13.4867 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -7.300 score on a scale | Standard Deviation 15.9008 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -4.785 score on a scale | Standard Deviation 13.9004 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -7.438 score on a scale | Standard Deviation 17.2899 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -7.638 score on a scale | Standard Deviation 15.0861 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -8.692 score on a scale | Standard Deviation 17.4611 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.908 score on a scale | Standard Deviation 9.4231 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -9.792 score on a scale | Standard Deviation 17.3534 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.530 score on a scale | Standard Deviation 6.2243 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -7.680 score on a scale | Standard Deviation 16.0389 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -11.980 score on a scale | Standard Deviation 12.1211 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -12.320 score on a scale | Standard Deviation 11.8315 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -15.130 score on a scale | Standard Deviation 8.6208 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -6.160 score on a scale | Standard Deviation 14.04 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 28.250 score on a scale | Standard Deviation 6.6991 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.570 score on a scale | Standard Deviation 10.3295 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -13.410 score on a scale | Standard Deviation 8.7252 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -6.330 score on a scale | Standard Deviation 14.3787 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -8.960 score on a scale | Standard Deviation 16.2228 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -6.910 score on a scale | Standard Deviation 14.688 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -7.370 score on a scale | Standard Deviation 15.5947 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.770 score on a scale | Standard Deviation 6.4534 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -8.470 score on a scale | Standard Deviation 15.7053 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -7.730 score on a scale | Standard Deviation 14.7041 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -9.200 score on a scale | Standard Deviation 15.1983 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -9.970 score on a scale | Standard Deviation 16.6191 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -11.580 score on a scale | Standard Deviation 12.9276 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -13.000 score on a scale | Standard Deviation 6.1248 |
Secondary
Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF
CRP of each participants was measured as a part of blood biochemical tests. A normal CRP value is less than (\<) 10 milligram per deciliter (mg/dL). A test result showing a CRP level greater than 10 mg/dL is a sign of chronic disease. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.15 mg/dL | Standard Deviation 0.978 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.21 mg/dL | Standard Deviation 1.144 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.47 mg/dL | Standard Deviation 0.795 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.08 mg/dL | Standard Deviation 1.299 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.05 mg/dL | Standard Deviation 1.09 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.19 mg/dL | Standard Deviation 1.278 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | -0.06 mg/dL | Standard Deviation 0.579 |
| Core Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.18 mg/dL | Standard Deviation 0.507 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.44 mg/dL | Standard Deviation 1.643 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.02 mg/dL | Standard Deviation 1.701 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.42 mg/dL | Standard Deviation 1.755 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | -0.31 mg/dL | Standard Deviation 1.692 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | -0.33 mg/dL | Standard Deviation 2.229 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.41 mg/dL | Standard Deviation 1.792 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | -0.63 mg/dL | Standard Deviation 2.308 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 2.50 mg/dL | Standard Deviation 4.012 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | -0.25 mg/dL | Standard Deviation 0.938 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | -0.49 mg/dL | Standard Deviation 2.893 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.08 mg/dL | Standard Deviation 1.943 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.39 mg/dL | Standard Deviation 1.438 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.49 mg/dL | Standard Deviation 2.713 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | -0.09 mg/dL | Standard Deviation 1.277 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.07 mg/dL | Standard Deviation 2.524 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 3.09 mg/dL | Standard Deviation 3.186 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.63 mg/dL | Standard Deviation 2.343 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.73 mg/dL | Standard Deviation 3.043 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.56 mg/dL | Standard Deviation 2.257 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.47 mg/dL | Standard Deviation 2.047 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.43 mg/dL | Standard Deviation 1.644 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.68 mg/dL | Standard Deviation 2.504 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.40 mg/dL | Standard Deviation 1.618 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.13 mg/dL | Standard Deviation 0.87 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.22 mg/dL | Standard Deviation 0.965 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.32 mg/dL | Standard Deviation 0.814 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | 0.48 mg/dL | Standard Deviation 1.25 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | 0.75 mg/dL | Standard Deviation 1.825 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | 0.90 mg/dL | Standard Deviation 1.859 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 0.94 mg/dL | Standard Deviation 1.097 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.46 mg/dL | Standard Deviation 0.855 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.23 mg/dL | Standard Deviation 0.525 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.05 mg/dL | Standard Deviation 0.389 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.36 mg/dL | Standard Deviation 1.18 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.38 mg/dL | Standard Deviation 1.004 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | 0.42 mg/dL | Standard Deviation 1.023 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | 0.81 mg/dL | Standard Deviation 1.834 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | 1.08 mg/dL | Standard Deviation 1.857 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | 0.99 mg/dL | Standard Deviation 1.783 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | 0.83 mg/dL | Standard Deviation 1.801 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | 0.80 mg/dL | Standard Deviation 1.828 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | 0.76 mg/dL | Standard Deviation 1.803 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | 1.10 mg/dL | Standard Deviation 1.914 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | 0.83 mg/dL | Standard Deviation 1.791 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | 0.25 mg/dL | Standard Deviation 1.642 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.10 mg/dL | Standard Deviation 0.849 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | 0.21 mg/dL | Standard Deviation 1.653 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | 0.58 mg/dL | Standard Deviation 1.405 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | -0.01 mg/dL | Standard Deviation 0.636 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.23 mg/dL | Standard Deviation 1.782 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | 0.29 mg/dL | Standard Deviation 1.592 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.30 mg/dL | Standard Deviation 0.518 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.10 mg/dL | Standard Deviation 0.835 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.83 mg/dL | Standard Deviation 2.893 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | 0.02 mg/dL | Standard Deviation 1.301 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | 0.10 mg/dL | Standard Deviation 1.625 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | 0.09 mg/dL | Standard Deviation 1.818 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | 0.25 mg/dL | Standard Deviation 1.49 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.15 mg/dL | Standard Deviation 0.652 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | 0.40 mg/dL | Standard Deviation 1.641 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | 0.38 mg/dL | Standard Deviation 1.459 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | 0.63 mg/dL | Standard Deviation 1.521 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.18 mg/dL | Standard Deviation 0.81 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | 0.47 mg/dL | Standard Deviation 1.465 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | -1.16 mg/dL | Standard Deviation 3.002 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.35 mg/dL | Standard Deviation 2.771 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | -1.04 mg/dL | Standard Deviation 3.06 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | -0.65 mg/dL | Standard Deviation 3.002 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.09 mg/dL | Standard Deviation 1.909 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | -1.12 mg/dL | Standard Deviation 2.881 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | -1.04 mg/dL | Standard Deviation 3.168 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | -0.20 mg/dL | Standard Deviation 1.262 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | -0.30 mg/dL | Standard Deviation 0.957 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | -0.87 mg/dL | Standard Deviation 2.213 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.02 mg/dL | Standard Deviation 2.618 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | -0.71 mg/dL | Standard Deviation 2.892 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.45 mg/dL | Standard Deviation 1.473 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | -0.94 mg/dL | Standard Deviation 3.036 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | -1.10 mg/dL | Standard Deviation 2.565 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | -1.04 mg/dL | Standard Deviation 2.757 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | -1.16 mg/dL | Standard Deviation 2.638 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | -0.50 mg/dL | Standard Deviation 3.73 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 3.10 mg/dL | Standard Deviation 3.316 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | -0.42 mg/dL | Standard Deviation 1.84 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | 0.98 mg/dL | Standard Deviation 1.764 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.28 mg/dL | Standard Deviation 0.87 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.37 mg/dL | Standard Deviation 0.66 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.33 mg/dL | Standard Deviation 1.048 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.65 mg/dL | Standard Deviation 1.682 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | 0.77 mg/dL | Standard Deviation 1.512 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | 0.75 mg/dL | Standard Deviation 1.678 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | 0.69 mg/dL | Standard Deviation 1.61 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | 0.67 mg/dL | Standard Deviation 1.516 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | 1.01 mg/dL | Standard Deviation 2.006 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | 0.86 mg/dL | Standard Deviation 1.559 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | 0.67 mg/dL | Standard Deviation 1.462 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | 0.72 mg/dL | Standard Deviation 1.43 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | 0.67 mg/dL | Standard Deviation 1.399 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | 0.97 mg/dL | Standard Deviation 1.686 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | 0.69 mg/dL | Standard Deviation 1.376 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | -0.02 mg/dL | Standard Deviation 0.239 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.11 mg/dL | Standard Deviation 0.277 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.07 mg/dL | Standard Deviation 0.68 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 0.81 mg/dL | Standard Deviation 0.736 |
Secondary
Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 4.1 or above=high disease activity, a value \>2.7 and \<=4.1=moderate disease activity and a value \<=2.7=low disease activity, value \<2.3=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.672 score on a scale | Standard Deviation 1.0587 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.226 score on a scale | Standard Deviation 1.2308 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.567 score on a scale | Standard Deviation 1.0958 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.277 score on a scale | Standard Deviation 0.5794 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 4.842 score on a scale | Standard Deviation 1.2628 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.790 score on a scale | Standard Deviation 0.8574 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.086 score on a scale | Standard Deviation 1.2175 |
| Core Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.032 score on a scale | Standard Deviation 1.323 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.806 score on a scale | Standard Deviation 1.4652 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.653 score on a scale | Standard Deviation 0.7404 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -0.913 score on a scale | Standard Deviation 0.964 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.313 score on a scale | Standard Deviation 0.4086 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.194 score on a scale | Standard Deviation 1.2869 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -0.807 score on a scale | Standard Deviation 0.7085 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.559 score on a scale | Standard Deviation 1.2972 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -0.744 score on a scale | Standard Deviation 1.3057 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.448 score on a scale | Standard Deviation 1.017 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.459 score on a scale | Standard Deviation 0.7658 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -0.662 score on a scale | Standard Deviation 1.149 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -0.664 score on a scale | Standard Deviation 1.3388 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.305 score on a scale | Standard Deviation 1.1055 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -0.569 score on a scale | Standard Deviation 1.2364 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.550 score on a scale | Standard Deviation 1.0307 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.704 score on a scale | Standard Deviation 1.1604 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.501 score on a scale | Standard Deviation 1.1683 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.691 score on a scale | Standard Deviation 0.5431 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.312 score on a scale | Standard Deviation 1.2535 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -1.108 score on a scale | Standard Deviation 0.5967 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.318 score on a scale | Standard Deviation 1.0756 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.448 score on a scale | Standard Deviation 1.0766 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.808 score on a scale | Standard Deviation 0.6209 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.095 score on a scale | Standard Deviation 0.8393 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.802 score on a scale | Standard Deviation 0.9214 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.313 score on a scale | Standard Deviation 1.3047 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.152 score on a scale | Standard Deviation 1.3004 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -0.688 score on a scale | Standard Deviation 1.2532 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.045 score on a scale | Standard Deviation 1.4527 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.020 score on a scale | Standard Deviation 1.4086 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.719 score on a scale | Standard Deviation 1.1249 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -0.713 score on a scale | Standard Deviation 1.3495 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -0.883 score on a scale | Standard Deviation 1.4812 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 4.780 score on a scale | Standard Deviation 0.9932 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -0.836 score on a scale | Standard Deviation 1.2718 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -0.779 score on a scale | Standard Deviation 1.2602 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -0.939 score on a scale | Standard Deviation 1.6417 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.657 score on a scale | Standard Deviation 1.128 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -0.817 score on a scale | Standard Deviation 1.3728 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -0.787 score on a scale | Standard Deviation 1.3827 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -0.864 score on a scale | Standard Deviation 1.4813 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -0.878 score on a scale | Standard Deviation 1.4321 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.353 score on a scale | Standard Deviation 0.5823 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.080 score on a scale | Standard Deviation 1.4327 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.054 score on a scale | Standard Deviation 1.0421 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -0.923 score on a scale | Standard Deviation 0.7435 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -0.821 score on a scale | Standard Deviation 1.4747 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.159 score on a scale | Standard Deviation 1.5168 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -0.846 score on a scale | Standard Deviation 1.4961 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.209 score on a scale | Standard Deviation 1.4589 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -1.093 score on a scale | Standard Deviation 1.3147 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -1.198 score on a scale | Standard Deviation 1.5077 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -1.267 score on a scale | Standard Deviation 1.7114 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.248 score on a scale | Standard Deviation 1.8622 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -1.232 score on a scale | Standard Deviation 1.814 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.033 score on a scale | Standard Deviation 1.3186 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -0.794 score on a scale | Standard Deviation 1.1386 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -0.688 score on a scale | Standard Deviation 1.1425 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.314 score on a scale | Standard Deviation 0.4634 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -0.850 score on a scale | Standard Deviation 1.2527 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -1.152 score on a scale | Standard Deviation 1.5226 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.607 score on a scale | Standard Deviation 0.7575 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.864 score on a scale | Standard Deviation 1.6578 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.680 score on a scale | Standard Deviation 1.3724 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -0.595 score on a scale | Standard Deviation 1.2832 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -0.801 score on a scale | Standard Deviation 1.5149 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -0.866 score on a scale | Standard Deviation 1.5055 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.475 score on a scale | Standard Deviation 0.7948 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -0.871 score on a scale | Standard Deviation 1.8144 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -1.012 score on a scale | Standard Deviation 1.7898 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -0.934 score on a scale | Standard Deviation 1.5769 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -0.753 score on a scale | Standard Deviation 1.3526 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -0.965 score on a scale | Standard Deviation 1.5133 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.710 score on a scale | Standard Deviation 1.2076 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.381 score on a scale | Standard Deviation 1.0262 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -0.652 score on a scale | Standard Deviation 1.1953 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -1.156 score on a scale | Standard Deviation 1.9211 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.218 score on a scale | Standard Deviation 1.0996 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -0.877 score on a scale | Standard Deviation 1.6018 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -1.184 score on a scale | Standard Deviation 1.8181 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.510 score on a scale | Standard Deviation 1.0611 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -0.696 score on a scale | Standard Deviation 1.3878 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -1.070 score on a scale | Standard Deviation 1.763 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.023 score on a scale | Standard Deviation 1.6672 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -0.948 score on a scale | Standard Deviation 1.4326 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.329 score on a scale | Standard Deviation 1.0122 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -0.653 score on a scale | Standard Deviation 1.2861 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.596 score on a scale | Standard Deviation 0.5478 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -0.761 score on a scale | Standard Deviation 1.5076 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -0.890 score on a scale | Standard Deviation 1.48 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -0.886 score on a scale | Standard Deviation 1.4063 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.501 score on a scale | Standard Deviation 1.119 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -0.818 score on a scale | Standard Deviation 1.4112 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -0.682 score on a scale | Standard Deviation 1.3581 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.120 score on a scale | Standard Deviation 1.5781 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.196 score on a scale | Standard Deviation 0.8728 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.881 score on a scale | Standard Deviation 0.6595 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -1.224 score on a scale | Standard Deviation 1.4763 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.265 score on a scale | Standard Deviation 1.5105 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.275 score on a scale | Standard Deviation 1.3575 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -1.167 score on a scale | Standard Deviation 0.6389 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 4.909 score on a scale | Standard Deviation 0.533 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -0.914 score on a scale | Standard Deviation 1.3941 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.057 score on a scale | Standard Deviation 1.3742 |
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF
The DAS28 index was a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above=high disease activity, a value greater than (\>) 3.2 and less than or equal to (\<=) 5.1=moderate disease activity and value \<=3.2=low disease activity, value \<2.6=disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.633 score on a scale | Standard Deviation 1.1583 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.719 score on a scale | Standard Deviation 0.9115 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.144 score on a scale | Standard Deviation 1.377 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.052 score on a scale | Standard Deviation 1.2322 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.479 score on a scale | Standard Deviation 1.252 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.212 score on a scale | Standard Deviation 0.5989 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -0.915 score on a scale | Standard Deviation 1.3442 |
| Core Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.546 score on a scale | Standard Deviation 1.1731 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.532 score on a scale | Standard Deviation 1.4324 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.674 score on a scale | Standard Deviation 1.0013 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -0.880 score on a scale | Standard Deviation 1.5753 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.340 score on a scale | Standard Deviation 0.544 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.870 score on a scale | Standard Deviation 1.3037 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -0.983 score on a scale | Standard Deviation 1.0665 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.005 score on a scale | Standard Deviation 0.9633 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.797 score on a scale | Standard Deviation 1.7366 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -0.686 score on a scale | Standard Deviation 1.2377 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.951 score on a scale | Standard Deviation 1.1584 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.401 score on a scale | Standard Deviation 0.7715 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.489 score on a scale | Standard Deviation 1.0301 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.452 score on a scale | Standard Deviation 1.0405 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.710 score on a scale | Standard Deviation 1.2693 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -0.593 score on a scale | Standard Deviation 1.4253 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -0.621 score on a scale | Standard Deviation 1.4654 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.658 score on a scale | Standard Deviation 0.4838 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.431 score on a scale | Standard Deviation 0.9735 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.012 score on a scale | Standard Deviation 0.8396 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -1.098 score on a scale | Standard Deviation 0.6243 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.870 score on a scale | Standard Deviation 0.7421 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.237 score on a scale | Standard Deviation 1.2485 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.971 score on a scale | Standard Deviation 0.9561 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.459 score on a scale | Standard Deviation 1.1873 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -0.755 score on a scale | Standard Deviation 1.5599 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -0.654 score on a scale | Standard Deviation 1.4252 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.739 score on a scale | Standard Deviation 0.976 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.749 score on a scale | Standard Deviation 1.1879 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.262 score on a scale | Standard Deviation 0.6308 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -0.910 score on a scale | Standard Deviation 1.4311 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.119 score on a scale | Standard Deviation 1.3126 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.460 score on a scale | Standard Deviation 0.9793 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.226 score on a scale | Standard Deviation 1.4651 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.021 score on a scale | Standard Deviation 1.5467 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.009 score on a scale | Standard Deviation 1.6211 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -0.790 score on a scale | Standard Deviation 1.5655 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -0.900 score on a scale | Standard Deviation 1.6899 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -0.849 score on a scale | Standard Deviation 1.5612 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -0.552 score on a scale | Standard Deviation 1.3993 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -0.779 score on a scale | Standard Deviation 1.589 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -0.634 score on a scale | Standard Deviation 1.4797 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -0.544 score on a scale | Standard Deviation 1.4247 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -0.653 score on a scale | Standard Deviation 1.4101 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.582 score on a scale | Standard Deviation 1.2502 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -0.804 score on a scale | Standard Deviation 1.4963 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.136 score on a scale | Standard Deviation 1.9269 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.928 score on a scale | Standard Deviation 1.9411 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.283 score on a scale | Standard Deviation 2.3802 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -1.316 score on a scale | Standard Deviation 2.1913 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -1.167 score on a scale | Standard Deviation 1.8142 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.697 score on a scale | Standard Deviation 1.0573 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -0.854 score on a scale | Standard Deviation 1.6351 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -0.996 score on a scale | Standard Deviation 1.7744 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -1.156 score on a scale | Standard Deviation 2.0018 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.696 score on a scale | Standard Deviation 1.3749 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.654 score on a scale | Standard Deviation 1.5342 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -0.683 score on a scale | Standard Deviation 1.4337 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.400 score on a scale | Standard Deviation 1.8959 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.148 score on a scale | Standard Deviation 1.0416 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -1.076 score on a scale | Standard Deviation 1.864 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.363 score on a scale | Standard Deviation 0.6115 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -1.015 score on a scale | Standard Deviation 1.7114 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.114 score on a scale | Standard Deviation 1.1754 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -1.262 score on a scale | Standard Deviation 2.2876 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -0.895 score on a scale | Standard Deviation 1.7231 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -0.622 score on a scale | Standard Deviation 1.4794 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.390 score on a scale | Standard Deviation 1.0558 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -0.651 score on a scale | Standard Deviation 1.5206 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -0.717 score on a scale | Standard Deviation 1.5407 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -0.973 score on a scale | Standard Deviation 2.0715 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -1.182 score on a scale | Standard Deviation 2.0758 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -0.733 score on a scale | Standard Deviation 1.6623 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -0.954 score on a scale | Standard Deviation 1.7462 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.446 score on a scale | Standard Deviation 1.0589 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -1.119 score on a scale | Standard Deviation 2.0381 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -0.881 score on a scale | Standard Deviation 1.7674 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -0.908 score on a scale | Standard Deviation 2.1318 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.026 score on a scale | Standard Deviation 1.8598 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -0.889 score on a scale | Standard Deviation 1.8339 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.727 score on a scale | Standard Deviation 1.3193 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.426 score on a scale | Standard Deviation 0.797 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -0.664 score on a scale | Standard Deviation 1.2855 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.849 score on a scale | Standard Deviation 1.1389 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -1.169 score on a scale | Standard Deviation 2.1891 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -0.830 score on a scale | Standard Deviation 1.5182 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -1.283 score on a scale | Standard Deviation 1.596 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.316 score on a scale | Standard Deviation 1.0018 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.265 score on a scale | Standard Deviation 1.5622 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -0.967 score on a scale | Standard Deviation 1.541 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.250 score on a scale | Standard Deviation 1.3487 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.475 score on a scale | Standard Deviation 0.9937 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.121 score on a scale | Standard Deviation 0.8512 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -1.199 score on a scale | Standard Deviation 0.6263 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.971 score on a scale | Standard Deviation 0.7646 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.623 score on a scale | Standard Deviation 0.5133 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -0.736 score on a scale | Standard Deviation 1.5585 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -0.976 score on a scale | Standard Deviation 1.6523 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -0.925 score on a scale | Standard Deviation 1.6162 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.593 score on a scale | Standard Deviation 0.5036 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -0.697 score on a scale | Standard Deviation 1.4635 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -0.684 score on a scale | Standard Deviation 1.4746 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.210 score on a scale | Standard Deviation 1.7566 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -0.991 score on a scale | Standard Deviation 1.5604 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.146 score on a scale | Standard Deviation 1.5067 |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF
ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 8.6 millimeter per hour (mm/hr) | Standard Deviation 14.66 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 33.1 millimeter per hour (mm/hr) | Standard Deviation 19.55 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 8.1 millimeter per hour (mm/hr) | Standard Deviation 14.36 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | 4.7 millimeter per hour (mm/hr) | Standard Deviation 10.64 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | 4.2 millimeter per hour (mm/hr) | Standard Deviation 9.53 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | 8.2 millimeter per hour (mm/hr) | Standard Deviation 17.51 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | 2.3 millimeter per hour (mm/hr) | Standard Deviation 12.72 |
| Core Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | 1.8 millimeter per hour (mm/hr) | Standard Deviation 10.14 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -2.7 millimeter per hour (mm/hr) | Standard Deviation 14.74 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -0.4 millimeter per hour (mm/hr) | Standard Deviation 11.04 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | 5.4 millimeter per hour (mm/hr) | Standard Deviation 15.78 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 0.2 millimeter per hour (mm/hr) | Standard Deviation 12.43 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 2.1 millimeter per hour (mm/hr) | Standard Deviation 18.56 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 14.11 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | 5.1 millimeter per hour (mm/hr) | Standard Deviation 23.65 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 44.4 millimeter per hour (mm/hr) | Standard Deviation 25.7 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | 1.2 millimeter per hour (mm/hr) | Standard Deviation 31.07 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -0.3 millimeter per hour (mm/hr) | Standard Deviation 11.56 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -0.1 millimeter per hour (mm/hr) | Standard Deviation 33.28 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -0.5 millimeter per hour (mm/hr) | Standard Deviation 17.72 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -1.5 millimeter per hour (mm/hr) | Standard Deviation 22.06 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.0 millimeter per hour (mm/hr) | Standard Deviation 23.33 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 51.8 millimeter per hour (mm/hr) | Standard Deviation 34.26 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 1.5 millimeter per hour (mm/hr) | Standard Deviation 11.63 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | 9.3 millimeter per hour (mm/hr) | Standard Deviation 19 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 35.3 millimeter per hour (mm/hr) | Standard Deviation 18.44 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | 3.9 millimeter per hour (mm/hr) | Standard Deviation 21.68 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 1.5 millimeter per hour (mm/hr) | Standard Deviation 10.28 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | 3.0 millimeter per hour (mm/hr) | Standard Deviation 23.46 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | 6.9 millimeter per hour (mm/hr) | Standard Deviation 18.59 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 1.4 millimeter per hour (mm/hr) | Standard Deviation 15.41 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | 6.8 millimeter per hour (mm/hr) | Standard Deviation 19.6 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 8.6 millimeter per hour (mm/hr) | Standard Deviation 15.37 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | 6.5 millimeter per hour (mm/hr) | Standard Deviation 18.39 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | 12.2 millimeter per hour (mm/hr) | Standard Deviation 18.88 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | 15.3 millimeter per hour (mm/hr) | Standard Deviation 17.84 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | 16.5 millimeter per hour (mm/hr) | Standard Deviation 18 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | 16.5 millimeter per hour (mm/hr) | Standard Deviation 17.88 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 33.9 millimeter per hour (mm/hr) | Standard Deviation 19.56 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 9.5 millimeter per hour (mm/hr) | Standard Deviation 15.59 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | 4.6 millimeter per hour (mm/hr) | Standard Deviation 10.21 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | 2.1 millimeter per hour (mm/hr) | Standard Deviation 10.8 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | 5.8 millimeter per hour (mm/hr) | Standard Deviation 10.9 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | 10.1 millimeter per hour (mm/hr) | Standard Deviation 19.73 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | 10.6 millimeter per hour (mm/hr) | Standard Deviation 19.7 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | 12.2 millimeter per hour (mm/hr) | Standard Deviation 18.67 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | 2.8 millimeter per hour (mm/hr) | Standard Deviation 13.45 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | 9.6 millimeter per hour (mm/hr) | Standard Deviation 18.32 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | 11.8 millimeter per hour (mm/hr) | Standard Deviation 18.9 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | 16.1 millimeter per hour (mm/hr) | Standard Deviation 17.46 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | 14.8 millimeter per hour (mm/hr) | Standard Deviation 20.93 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | 15.2 millimeter per hour (mm/hr) | Standard Deviation 18.43 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | -2.5 millimeter per hour (mm/hr) | Standard Deviation 18.18 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | 1.4 millimeter per hour (mm/hr) | Standard Deviation 18.92 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 15.64 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | -6.1 millimeter per hour (mm/hr) | Standard Deviation 13.12 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | 0.8 millimeter per hour (mm/hr) | Standard Deviation 17.87 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | 3.5 millimeter per hour (mm/hr) | Standard Deviation 14.36 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | 3.5 millimeter per hour (mm/hr) | Standard Deviation 19.91 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | 0.6 millimeter per hour (mm/hr) | Standard Deviation 11.96 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | 1.6 millimeter per hour (mm/hr) | Standard Deviation 20.1 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | 3.1 millimeter per hour (mm/hr) | Standard Deviation 20.22 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -2.4 millimeter per hour (mm/hr) | Standard Deviation 16.48 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 41.2 millimeter per hour (mm/hr) | Standard Deviation 25.81 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | -2.5 millimeter per hour (mm/hr) | Standard Deviation 19.24 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | -1.3 millimeter per hour (mm/hr) | Standard Deviation 18.77 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 1.5 millimeter per hour (mm/hr) | Standard Deviation 16.66 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | 1.0 millimeter per hour (mm/hr) | Standard Deviation 17.38 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -1.4 millimeter per hour (mm/hr) | Standard Deviation 20.41 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | -1.2 millimeter per hour (mm/hr) | Standard Deviation 13.39 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | -3.8 millimeter per hour (mm/hr) | Standard Deviation 16.78 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | 4.7 millimeter per hour (mm/hr) | Standard Deviation 21.64 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -3.8 millimeter per hour (mm/hr) | Standard Deviation 21.06 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 49.9 millimeter per hour (mm/hr) | Standard Deviation 34.91 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | -5.6 millimeter per hour (mm/hr) | Standard Deviation 26.41 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | -4.6 millimeter per hour (mm/hr) | Standard Deviation 23.94 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | -7.4 millimeter per hour (mm/hr) | Standard Deviation 39.76 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -4.1 millimeter per hour (mm/hr) | Standard Deviation 30.55 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 19.89 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.5 millimeter per hour (mm/hr) | Standard Deviation 24.22 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | -5.7 millimeter per hour (mm/hr) | Standard Deviation 28.67 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | -6.3 millimeter per hour (mm/hr) | Standard Deviation 28.79 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -0.8 millimeter per hour (mm/hr) | Standard Deviation 31.33 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | -5.2 millimeter per hour (mm/hr) | Standard Deviation 35.53 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -2.3 millimeter per hour (mm/hr) | Standard Deviation 17.05 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -2.3 millimeter per hour (mm/hr) | Standard Deviation 33.6 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | -4.4 millimeter per hour (mm/hr) | Standard Deviation 26.88 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | -4.8 millimeter per hour (mm/hr) | Standard Deviation 21.23 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | -3.5 millimeter per hour (mm/hr) | Standard Deviation 21.04 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | -6.0 millimeter per hour (mm/hr) | Standard Deviation 25.17 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -0.9 millimeter per hour (mm/hr) | Standard Deviation 11.77 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | -0.8 millimeter per hour (mm/hr) | Standard Deviation 8.28 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | 7.1 millimeter per hour (mm/hr) | Standard Deviation 28.04 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | 0.8 millimeter per hour (mm/hr) | Standard Deviation 23.29 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | 4.5 millimeter per hour (mm/hr) | Standard Deviation 20.74 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | 8.1 millimeter per hour (mm/hr) | Standard Deviation 26.33 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | 3.7 millimeter per hour (mm/hr) | Standard Deviation 25.95 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | 3.0 millimeter per hour (mm/hr) | Standard Deviation 31.65 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 32.3 millimeter per hour (mm/hr) | Standard Deviation 18.89 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | 5.7 millimeter per hour (mm/hr) | Standard Deviation 32.19 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -4.0 millimeter per hour (mm/hr) | Standard Deviation 9.59 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | 3.0 millimeter per hour (mm/hr) | Standard Deviation 26.24 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | -0.8 millimeter per hour (mm/hr) | Standard Deviation 23.88 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | -1.9 millimeter per hour (mm/hr) | Standard Deviation 6.54 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | 0.9 millimeter per hour (mm/hr) | Standard Deviation 22.43 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | 1.2 millimeter per hour (mm/hr) | Standard Deviation 26.16 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -0.3 millimeter per hour (mm/hr) | Standard Deviation 25.25 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | 2.3 millimeter per hour (mm/hr) | Standard Deviation 21.19 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | 4.5 millimeter per hour (mm/hr) | Standard Deviation 15.46 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | 2.8 millimeter per hour (mm/hr) | Standard Deviation 25.88 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | 2.7 millimeter per hour (mm/hr) | Standard Deviation 16.91 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -2.6 millimeter per hour (mm/hr) | Standard Deviation 16.87 |
Secondary
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF
Degree of disability was self-evaluated by participant using HAQ-DI.Assessment was made based on activities capable without any aids/devices.20-question instrument assessed degree of difficulty person had in accomplishing tasks in 8 functional areas(dressing,arising,eating,walking,hygiene,reaching,gripping,and activities of daily living).Responses in each functional area were scored from 0(indicated no difficulty)to 3(indicated inability to perform task in that area).Overall score computed as: sum of domain scores and divided by number of domains answered.Total possible score range:0-3 where 0=least difficulty and 3=extreme difficulty.Data for Core Treatment Phase from Week 0-10 is reported according to participant re-randomization in 4 arms at Week 12.Data reported for Extension Phase from Baseline to Week 24,is same data for Core Treatment Phase,but excluding participants who received at least 1 dose of drug and had at least 1 postdose primary efficacy measurement after Week 24-72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | 0.07 units on a scale | Standard Deviation 0.163 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.04 units on a scale | Standard Deviation 0.4 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | 0.03 units on a scale | Standard Deviation 0.197 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | 0.12 units on a scale | Standard Deviation 0.358 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.04 units on a scale | Standard Deviation 0.181 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | 0.03 units on a scale | Standard Deviation 0.376 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.04 units on a scale | Standard Deviation 0.483 |
| Core Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.90 units on a scale | Standard Deviation 0.816 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.25 units on a scale | Standard Deviation 0.357 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.03 units on a scale | Standard Deviation 0.399 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.11 units on a scale | Standard Deviation 0.395 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.21 units on a scale | Standard Deviation 0.341 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.23 units on a scale | Standard Deviation 0.395 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 1.04 units on a scale | Standard Deviation 0.77 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.25 units on a scale | Standard Deviation 0.46 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.38 units on a scale | Standard Deviation 0.595 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.10 units on a scale | Standard Deviation 0.371 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.23 units on a scale | Standard Deviation 0.574 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.15 units on a scale | Standard Deviation 0.619 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.08 units on a scale | Standard Deviation 0.297 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.88 units on a scale | Standard Deviation 0.744 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.10 units on a scale | Standard Deviation 0.344 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.06 units on a scale | Standard Deviation 0.459 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.11 units on a scale | Standard Deviation 0.495 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.05 units on a scale | Standard Deviation 0.404 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | 0.02 units on a scale | Standard Deviation 0.464 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.02 units on a scale | Standard Deviation 0.579 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | 0.01 units on a scale | Standard Deviation 0.258 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 1.08 units on a scale | Standard Deviation 0.673 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.04 units on a scale | Standard Deviation 0.421 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.03 units on a scale | Standard Deviation 0.316 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.02 units on a scale | Standard Deviation 0.497 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | 0.10 units on a scale | Standard Deviation 0.369 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.13 units on a scale | Standard Deviation 0.534 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | 0.07 units on a scale | Standard Deviation 0.174 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.85 units on a scale | Standard Deviation 0.702 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | 0.02 units on a scale | Standard Deviation 0.203 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.07 units on a scale | Standard Deviation 0.174 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | 0.02 units on a scale | Standard Deviation 0.405 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.07 units on a scale | Standard Deviation 0.426 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.07 units on a scale | Standard Deviation 0.517 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | -0.10 units on a scale | Standard Deviation 0.521 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | -0.09 units on a scale | Standard Deviation 0.596 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.13 units on a scale | Standard Deviation 0.545 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.04 units on a scale | Standard Deviation 0.62 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | -0.10 units on a scale | Standard Deviation 0.557 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.14 units on a scale | Standard Deviation 0.588 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.14 units on a scale | Standard Deviation 0.629 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | -0.13 units on a scale | Standard Deviation 0.664 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.14 units on a scale | Standard Deviation 0.682 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | -0.13 units on a scale | Standard Deviation 0.672 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | -0.17 units on a scale | Standard Deviation 0.632 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | -0.24 units on a scale | Standard Deviation 0.514 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.25 units on a scale | Standard Deviation 0.565 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | -0.26 units on a scale | Standard Deviation 0.469 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 1.20 units on a scale | Standard Deviation 0.789 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | -0.22 units on a scale | Standard Deviation 0.542 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.23 units on a scale | Standard Deviation 0.467 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.22 units on a scale | Standard Deviation 0.354 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.34 units on a scale | Standard Deviation 0.34 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.26 units on a scale | Standard Deviation 0.495 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.30 units on a scale | Standard Deviation 0.485 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | -0.20 units on a scale | Standard Deviation 0.522 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.30 units on a scale | Standard Deviation 0.341 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.47 units on a scale | Standard Deviation 0.647 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | -0.20 units on a scale | Standard Deviation 0.54 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.33 units on a scale | Standard Deviation 0.388 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.08 units on a scale | Standard Deviation 0.423 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.31 units on a scale | Standard Deviation 0.566 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.18 units on a scale | Standard Deviation 0.534 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | -0.31 units on a scale | Standard Deviation 0.401 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.25 units on a scale | Standard Deviation 0.565 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.19 units on a scale | Standard Deviation 0.624 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.04 units on a scale | Standard Deviation 0.262 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.13 units on a scale | Standard Deviation 0.51 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.28 units on a scale | Standard Deviation 0.569 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | -0.25 units on a scale | Standard Deviation 0.448 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.16 units on a scale | Standard Deviation 0.496 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | -0.13 units on a scale | Standard Deviation 0.518 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.18 units on a scale | Standard Deviation 0.45 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | -0.15 units on a scale | Standard Deviation 0.575 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.16 units on a scale | Standard Deviation 0.458 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | -0.18 units on a scale | Standard Deviation 0.441 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.18 units on a scale | Standard Deviation 0.464 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | -0.17 units on a scale | Standard Deviation 0.48 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.21 units on a scale | Standard Deviation 0.443 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.19 units on a scale | Standard Deviation 0.429 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.09 units on a scale | Standard Deviation 0.355 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.05 units on a scale | Standard Deviation 0.333 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.07 units on a scale | Standard Deviation 0.478 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.76 units on a scale | Standard Deviation 0.605 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | -0.12 units on a scale | Standard Deviation 0.452 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | 0.24 units on a scale | Standard Deviation 0.37 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | 0.25 units on a scale | Standard Deviation 0.391 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.94 units on a scale | Standard Deviation 0.607 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | 0.28 units on a scale | Standard Deviation 0.362 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | 0.24 units on a scale | Standard Deviation 0.473 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | 0.06 units on a scale | Standard Deviation 0.461 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.04 units on a scale | Standard Deviation 0.457 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.10 units on a scale | Standard Deviation 0.428 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.05 units on a scale | Standard Deviation 0.334 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | 0.24 units on a scale | Standard Deviation 0.37 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | 0.18 units on a scale | Standard Deviation 0.457 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | 0.28 units on a scale | Standard Deviation 0.471 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | 0.23 units on a scale | Standard Deviation 0.77 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | 0.19 units on a scale | Standard Deviation 0.409 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | 0.26 units on a scale | Standard Deviation 0.488 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | 0.04 units on a scale | Standard Deviation 0.51 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | 0.04 units on a scale | Standard Deviation 0.604 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | 0.23 units on a scale | Standard Deviation 0.432 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | 0.00 units on a scale | Standard Deviation 0.27 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.04 units on a scale | Standard Deviation 0.507 |
Secondary
Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF
Intensity and severity of pain associated with rheumatoid arthritis (RA) were indicated by the participant on a score sheet, Pain/disease activity assessments reported by the participant, by placing a mark on a 100 millimeter (mm) horizontal VAS. Pain assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -18.4 millimeter | Standard Deviation 28.02 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -9.8 millimeter | Standard Deviation 16.5 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -17.4 millimeter | Standard Deviation 27.91 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -15.7 millimeter | Standard Deviation 23.03 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -8.5 millimeter | Standard Deviation 25.01 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -13.9 millimeter | Standard Deviation 18.95 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -5.7 millimeter | Standard Deviation 15.5 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 56.7 millimeter | Standard Deviation 32.02 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 55.9 millimeter | Standard Deviation 30.33 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -8.0 millimeter | Standard Deviation 24.1 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -9.2 millimeter | Standard Deviation 15.57 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -14.2 millimeter | Standard Deviation 30.92 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -13.4 millimeter | Standard Deviation 26.58 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -8.4 millimeter | Standard Deviation 18.57 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -9.8 millimeter | Standard Deviation 18.35 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -3.3 millimeter | Standard Deviation 15.47 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -15.1 millimeter | Standard Deviation 18.89 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 56.9 millimeter | Standard Deviation 33.07 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -18.5 millimeter | Standard Deviation 22.7 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -20.0 millimeter | Standard Deviation 28.15 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -3.3 millimeter | Standard Deviation 22.53 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -8.4 millimeter | Standard Deviation 21.23 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -9.6 millimeter | Standard Deviation 21.94 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -14.7 millimeter | Standard Deviation 23.67 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -16.8 millimeter | Standard Deviation 20.23 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -6.3 millimeter | Standard Deviation 17.61 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -17.7 millimeter | Standard Deviation 16.88 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.8 millimeter | Standard Deviation 19.07 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -12.6 millimeter | Standard Deviation 14.88 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 60.3 millimeter | Standard Deviation 20.78 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -15.9 millimeter | Standard Deviation 14.77 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -14.9 millimeter | Standard Deviation 14.69 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -20.3 millimeter | Standard Deviation 29.2 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -23.5 millimeter | Standard Deviation 26.93 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -21.3 millimeter | Standard Deviation 31.66 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -11.2 millimeter | Standard Deviation 17.32 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -22.5 millimeter | Standard Deviation 26.09 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -22.8 millimeter | Standard Deviation 23.35 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -21.5 millimeter | Standard Deviation 26.83 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -9.5 millimeter | Standard Deviation 23.09 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -21.6 millimeter | Standard Deviation 23.42 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -21.0 millimeter | Standard Deviation 31.09 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -18.5 millimeter | Standard Deviation 28.19 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 57.5 millimeter | Standard Deviation 28.43 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -14.7 millimeter | Standard Deviation 19.04 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -21.3 millimeter | Standard Deviation 29.91 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -19.4 millimeter | Standard Deviation 30.09 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -19.5 millimeter | Standard Deviation 25.19 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -7.4 millimeter | Standard Deviation 15.71 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -16.4 millimeter | Standard Deviation 24.02 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -19.9 millimeter | Standard Deviation 27.82 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -22.6 millimeter | Standard Deviation 28.54 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -6.5 millimeter | Standard Deviation 21.29 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -7.1 millimeter | Standard Deviation 24.97 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 52.5 millimeter | Standard Deviation 29.96 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -3.4 millimeter | Standard Deviation 17.57 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -12.0 millimeter | Standard Deviation 27.4 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -12.8 millimeter | Standard Deviation 34.33 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -7.6 millimeter | Standard Deviation 26.27 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -11.4 millimeter | Standard Deviation 20.57 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -9.5 millimeter | Standard Deviation 16.32 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -9.9 millimeter | Standard Deviation 20.54 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -11.4 millimeter | Standard Deviation 21.87 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -10.2 millimeter | Standard Deviation 22.65 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -14.1 millimeter | Standard Deviation 29.22 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -10.5 millimeter | Standard Deviation 28.04 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -15.1 millimeter | Standard Deviation 35.6 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -13.9 millimeter | Standard Deviation 34.19 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -13.8 millimeter | Standard Deviation 36.26 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -14.2 millimeter | Standard Deviation 33.99 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -8.2 millimeter | Standard Deviation 27.93 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -10.5 millimeter | Standard Deviation 26.79 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 54.2 millimeter | Standard Deviation 32.67 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -16.0 millimeter | Standard Deviation 31.43 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -20.7 millimeter | Standard Deviation 29.18 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -15.0 millimeter | Standard Deviation 24.61 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -21.8 millimeter | Standard Deviation 22.14 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -17.7 millimeter | Standard Deviation 31.37 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -18.9 millimeter | Standard Deviation 31.3 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -14.2 millimeter | Standard Deviation 19.33 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -20.8 millimeter | Standard Deviation 30.07 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -19.1 millimeter | Standard Deviation 31.38 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -18.9 millimeter | Standard Deviation 33.97 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -16.6 millimeter | Standard Deviation 27.97 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -16.6 millimeter | Standard Deviation 27.52 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -18.2 millimeter | Standard Deviation 29.42 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -17.3 millimeter | Standard Deviation 28.8 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -20.8 millimeter | Standard Deviation 30.17 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -17.8 millimeter | Standard Deviation 23.49 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -7.5 millimeter | Standard Deviation 21.19 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -7.5 millimeter | Standard Deviation 21.82 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -3.0 millimeter | Standard Deviation 23.42 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -1.9 millimeter | Standard Deviation 19.67 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -4.0 millimeter | Standard Deviation 14.57 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -7.3 millimeter | Standard Deviation 17.09 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -8.8 millimeter | Standard Deviation 18.18 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -12.9 millimeter | Standard Deviation 14.65 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -5.5 millimeter | Standard Deviation 15.59 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -8.3 millimeter | Standard Deviation 16.59 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 56.4 millimeter | Standard Deviation 18.78 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -13.3 millimeter | Standard Deviation 21.07 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -5.6 millimeter | Standard Deviation 17.02 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -8.3 millimeter | Standard Deviation 17.86 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -8.8 millimeter | Standard Deviation 17.57 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -13.9 millimeter | Standard Deviation 18.53 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -10.1 millimeter | Standard Deviation 20.25 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -14.2 millimeter | Standard Deviation 13.38 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -14.1 millimeter | Standard Deviation 17.95 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -14.7 millimeter | Standard Deviation 12.96 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -16.4 millimeter | Standard Deviation 18.84 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -14.1 millimeter | Standard Deviation 15.81 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -10.3 millimeter | Standard Deviation 17.97 |
Secondary
Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF
Participants were evaluated on their disease activity of RA, and entered the result on the score sheet, disease activity assessments reported by the participant, by placing a mark on a 100 mm horizontal VAS. The scale ranged from 0-100 mm, where 0 indicated no disease activity (symptom free and no arthritis symptoms) and 100 represented maximum disease activity (maximum arthritis disease activity). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -7.2 millimeter | Standard Deviation 25.53 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -15.9 millimeter | Standard Deviation 27.17 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -16.7 millimeter | Standard Deviation 27.33 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -11.5 millimeter | Standard Deviation 19.27 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -8.1 millimeter | Standard Deviation 16.76 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -1.4 millimeter | Standard Deviation 10.52 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 56.2 millimeter | Standard Deviation 31.2 |
| Core Treatment Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -15.0 millimeter | Standard Deviation 25.59 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 54.9 millimeter | Standard Deviation 32.83 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -13.4 millimeter | Standard Deviation 29.22 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -6.9 millimeter | Standard Deviation 23.69 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -8.4 millimeter | Standard Deviation 14.28 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -7.4 millimeter | Standard Deviation 18.94 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.1 millimeter | Standard Deviation 13.2 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -12.7 millimeter | Standard Deviation 25.46 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -8.8 millimeter | Standard Deviation 16.43 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -16.3 millimeter | Standard Deviation 27.1 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -7.4 millimeter | Standard Deviation 24.36 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -13.1 millimeter | Standard Deviation 22.86 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -14.1 millimeter | Standard Deviation 24.07 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -8.9 millimeter | Standard Deviation 24.79 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.6 millimeter | Standard Deviation 20.66 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -12.7 millimeter | Standard Deviation 26.93 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 55.6 millimeter | Standard Deviation 34.74 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -3.9 millimeter | Standard Deviation 14.72 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -16.8 millimeter | Standard Deviation 20.74 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -13.5 millimeter | Standard Deviation 17.73 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.7 millimeter | Standard Deviation 14.21 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 57.7 millimeter | Standard Deviation 20.12 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -14.8 millimeter | Standard Deviation 16.5 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -13.1 millimeter | Standard Deviation 20.03 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -12.3 millimeter | Standard Deviation 13.5 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -23.5 millimeter | Standard Deviation 25.13 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -17.4 millimeter | Standard Deviation 23.95 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -21.4 millimeter | Standard Deviation 29.91 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -20.5 millimeter | Standard Deviation 26.49 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -22.9 millimeter | Standard Deviation 27.86 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -20.7 millimeter | Standard Deviation 28.39 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -21.9 millimeter | Standard Deviation 24.06 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -9.3 millimeter | Standard Deviation 17.76 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -2.6 millimeter | Standard Deviation 10.59 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -8.5 millimeter | Standard Deviation 24.24 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -16.2 millimeter | Standard Deviation 27.05 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -20.9 millimeter | Standard Deviation 24.16 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -20.0 millimeter | Standard Deviation 24.13 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -19.2 millimeter | Standard Deviation 27.12 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -12.3 millimeter | Standard Deviation 19.83 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -18.7 millimeter | Standard Deviation 27.02 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -17.7 millimeter | Standard Deviation 22.48 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 57.2 millimeter | Standard Deviation 27.56 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -22.9 millimeter | Standard Deviation 27.38 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -20.9 millimeter | Standard Deviation 24.8 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -13.3 millimeter | Standard Deviation 26.52 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -16.6 millimeter | Standard Deviation 34.47 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -10.8 millimeter | Standard Deviation 17.92 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -17.4 millimeter | Standard Deviation 31.23 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -9.5 millimeter | Standard Deviation 20.91 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -9.4 millimeter | Standard Deviation 15.21 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -11.2 millimeter | Standard Deviation 27.25 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -8.2 millimeter | Standard Deviation 22.01 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -13.5 millimeter | Standard Deviation 27.56 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.2 millimeter | Standard Deviation 14.7 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -17.2 millimeter | Standard Deviation 35.22 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -11.6 millimeter | Standard Deviation 32.31 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -13.7 millimeter | Standard Deviation 22.84 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -16.5 millimeter | Standard Deviation 32.23 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -5.8 millimeter | Standard Deviation 24.73 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -18.3 millimeter | Standard Deviation 35.75 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -11.5 millimeter | Standard Deviation 25.73 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -9.2 millimeter | Standard Deviation 27.18 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -10.5 millimeter | Standard Deviation 24.46 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 51.0 millimeter | Standard Deviation 32.93 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -14.2 millimeter | Standard Deviation 24.86 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -14.5 millimeter | Standard Deviation 25.67 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -13.6 millimeter | Standard Deviation 24.99 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -13.5 millimeter | Standard Deviation 24.9 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -14.1 millimeter | Standard Deviation 25.89 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -12.8 millimeter | Standard Deviation 23.57 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -16.6 millimeter | Standard Deviation 25.83 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -13.2 millimeter | Standard Deviation 23.44 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -17.7 millimeter | Standard Deviation 21.66 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -16.5 millimeter | Standard Deviation 26.51 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -14.2 millimeter | Standard Deviation 27.03 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -9.5 millimeter | Standard Deviation 25.94 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -16.2 millimeter | Standard Deviation 28.2 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -14.5 millimeter | Standard Deviation 24.66 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -12.4 millimeter | Standard Deviation 28 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -6.0 millimeter | Standard Deviation 23.28 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -5.5 millimeter | Standard Deviation 24.34 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -12.2 millimeter | Standard Deviation 23.48 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -3.6 millimeter | Standard Deviation 21.18 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 52.3 millimeter | Standard Deviation 33.74 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | 0.2 millimeter | Standard Deviation 16.61 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -2.7 millimeter | Standard Deviation 14.71 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -13.6 millimeter | Standard Deviation 19.38 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 53.9 millimeter | Standard Deviation 18.43 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -7.0 millimeter | Standard Deviation 13.75 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -13.4 millimeter | Standard Deviation 15.37 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -13.9 millimeter | Standard Deviation 18.33 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -13.0 millimeter | Standard Deviation 18.05 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -11.3 millimeter | Standard Deviation 14.59 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -11.2 millimeter | Standard Deviation 25.45 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -10.3 millimeter | Standard Deviation 21.95 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -10.9 millimeter | Standard Deviation 21.74 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -7.7 millimeter | Standard Deviation 18.61 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -5.2 millimeter | Standard Deviation 17.14 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -5.3 millimeter | Standard Deviation 21.65 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -4.0 millimeter | Standard Deviation 19.56 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -3.5 millimeter | Standard Deviation 19.43 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -4.7 millimeter | Standard Deviation 20.23 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -2.3 millimeter | Standard Deviation 19.11 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -0.9 millimeter | Standard Deviation 17.86 |
Secondary
Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF
The Physician's Global Assessment of Disease Activity was recorded using the 100 mm horizontal VAS. Physician rated participant's RA disease activity on a scale ranged from 0-100 mm, where 0 indicated no disease activity (no arthritis) and 100 represented maximum disease activity (maximum arthritis). Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -16.8 millimeter | Standard Deviation 16.83 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -28.4 millimeter | Standard Deviation 30.15 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -23.3 millimeter | Standard Deviation 26.5 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -28.9 millimeter | Standard Deviation 25.67 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -36.7 millimeter | Standard Deviation 30.38 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -23.8 millimeter | Standard Deviation 26.32 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -20.7 millimeter | Standard Deviation 13.62 |
| Core Treatment Phase: Placebo | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 63.3 millimeter | Standard Deviation 29.63 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -18.3 millimeter | Standard Deviation 21.35 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -9.4 millimeter | Standard Deviation 21.99 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -19.7 millimeter | Standard Deviation 20.22 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -13.6 millimeter | Standard Deviation 17.95 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 57.9 millimeter | Standard Deviation 22.02 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -16.8 millimeter | Standard Deviation 19.68 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -24.3 millimeter | Standard Deviation 22.97 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -17.6 millimeter | Standard Deviation 21.57 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -23.4 millimeter | Standard Deviation 29.34 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -17.6 millimeter | Standard Deviation 26.03 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -20.6 millimeter | Standard Deviation 27.81 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 62.4 millimeter | Standard Deviation 19.41 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -17.8 millimeter | Standard Deviation 27.46 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -19.0 millimeter | Standard Deviation 30.18 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -13.3 millimeter | Standard Deviation 23.08 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -19.6 millimeter | Standard Deviation 27.81 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -8.1 millimeter | Standard Deviation 18.53 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -19.1 millimeter | Standard Deviation 20.38 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -10.1 millimeter | Standard Deviation 16.68 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -13.8 millimeter | Standard Deviation 18.01 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -10.0 millimeter | Standard Deviation 23.18 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -14.7 millimeter | Standard Deviation 21.15 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 54.0 millimeter | Standard Deviation 27.28 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -14.5 millimeter | Standard Deviation 23.89 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -28.6 millimeter | Standard Deviation 33.01 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -30.4 millimeter | Standard Deviation 33.71 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -23.6 millimeter | Standard Deviation 26.84 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -30.6 millimeter | Standard Deviation 29.64 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -26.9 millimeter | Standard Deviation 28.12 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -15.6 millimeter | Standard Deviation 17.52 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -18.2 millimeter | Standard Deviation 12.6 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -20.5 millimeter | Standard Deviation 24.71 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -26.5 millimeter | Standard Deviation 32.75 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -17.7 millimeter | Standard Deviation 22.4 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -28.4 millimeter | Standard Deviation 32.79 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -23.6 millimeter | Standard Deviation 29.57 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -25.9 millimeter | Standard Deviation 25.94 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -25.8 millimeter | Standard Deviation 32.03 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -34.8 millimeter | Standard Deviation 32.06 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -35.1 millimeter | Standard Deviation 36.51 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 60.8 millimeter | Standard Deviation 30.56 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -26.6 millimeter | Standard Deviation 34.81 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -35.2 millimeter | Standard Deviation 38.69 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -31.2 millimeter | Standard Deviation 34.51 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -16.8 millimeter | Standard Deviation 17.66 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -17.2 millimeter | Standard Deviation 26.17 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -30.2 millimeter | Standard Deviation 20.74 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -24.7 millimeter | Standard Deviation 26.27 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -25.0 millimeter | Standard Deviation 24.91 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -20.6 millimeter | Standard Deviation 22.65 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -22.4 millimeter | Standard Deviation 26.72 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -23.8 millimeter | Standard Deviation 30 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 56.4 millimeter | Standard Deviation 22.41 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -23.0 millimeter | Standard Deviation 28.85 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -22.9 millimeter | Standard Deviation 26.79 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -11.5 millimeter | Standard Deviation 20.62 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -14.7 millimeter | Standard Deviation 28.22 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -20.2 millimeter | Standard Deviation 26.75 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -23.1 millimeter | Standard Deviation 20.53 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -22.6 millimeter | Standard Deviation 20.34 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -19.7 millimeter | Standard Deviation 30.66 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -17.7 millimeter | Standard Deviation 20.6 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -16.7 millimeter | Standard Deviation 16.88 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -19.0 millimeter | Standard Deviation 31.12 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -16.3 millimeter | Standard Deviation 29.29 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 60.5 millimeter | Standard Deviation 18.8 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -13.9 millimeter | Standard Deviation 23.89 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -17.7 millimeter | Standard Deviation 28.58 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -20.3 millimeter | Standard Deviation 28.83 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -20.8 millimeter | Standard Deviation 30.65 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -24.5 millimeter | Standard Deviation 30.19 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -21.7 millimeter | Standard Deviation 28.61 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -18.5 millimeter | Standard Deviation 26.87 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -20.7 millimeter | Standard Deviation 29.71 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -18.7 millimeter | Standard Deviation 31.17 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -22.7 millimeter | Standard Deviation 31.6 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -19.5 millimeter | Standard Deviation 29.54 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -21.2 millimeter | Standard Deviation 30.95 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -22.4 millimeter | Standard Deviation 32.85 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -19.0 millimeter | Standard Deviation 32.29 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -24.4 millimeter | Standard Deviation 33.78 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -26.3 millimeter | Standard Deviation 36.36 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -20.6 millimeter | Standard Deviation 31.61 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -24.7 millimeter | Standard Deviation 36.95 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -7.5 millimeter | Standard Deviation 34.52 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 49.6 millimeter | Standard Deviation 27.15 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | 6.8 millimeter | Standard Deviation 27.72 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | 8.2 millimeter | Standard Deviation 29.78 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -15.6 millimeter | Standard Deviation 42.85 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -8.9 millimeter | Standard Deviation 23.36 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -12.7 millimeter | Standard Deviation 17.13 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | 6.0 millimeter | Standard Deviation 29.28 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -19.7 millimeter | Standard Deviation 19.93 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -16.7 millimeter | Standard Deviation 25.66 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -6.6 millimeter | Standard Deviation 20.13 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | 8.6 millimeter | Standard Deviation 27.33 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -17.2 millimeter | Standard Deviation 22.32 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | 0.4 millimeter | Standard Deviation 34.48 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -14.6 millimeter | Standard Deviation 19.79 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | 3.7 millimeter | Standard Deviation 33.33 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -2.9 millimeter | Standard Deviation 36.17 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -6.8 millimeter | Standard Deviation 33.6 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | 8.5 millimeter | Standard Deviation 25.89 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | 4.0 millimeter | Standard Deviation 32.69 |
Secondary
Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF
The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 26 or above=high disease activity, a value \>11 and \<=26=moderate disease activity and value \<=11=low disease activity, value \<=3.3=disease remission. Higher scores indicated higher disease activity. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.760 score on a scale | Standard Deviation 13.4649 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.620 score on a scale | Standard Deviation 7.596 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -14.107 score on a scale | Standard Deviation 13.4448 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -7.767 score on a scale | Standard Deviation 9.6279 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -12.167 score on a scale | Standard Deviation 14.0241 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -10.260 score on a scale | Standard Deviation 8.9168 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 29.767 score on a scale | Standard Deviation 13.8824 |
| Core Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -6.793 score on a scale | Standard Deviation 10.2078 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -11.136 score on a scale | Standard Deviation 18.078 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.607 score on a scale | Standard Deviation 7.1229 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -10.221 score on a scale | Standard Deviation 11.8874 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -13.536 score on a scale | Standard Deviation 13.7755 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -12.700 score on a scale | Standard Deviation 11.1552 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -8.421 score on a scale | Standard Deviation 17.5072 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 34.986 score on a scale | Standard Deviation 16.9418 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -12.086 score on a scale | Standard Deviation 16.8719 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -6.907 score on a scale | Standard Deviation 15.9803 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.643 score on a scale | Standard Deviation 14.2285 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -6.836 score on a scale | Standard Deviation 12.3932 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -7.171 score on a scale | Standard Deviation 16.5184 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -8.521 score on a scale | Standard Deviation 14.865 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.100 score on a scale | Standard Deviation 9.3523 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 33.750 score on a scale | Standard Deviation 11.5847 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -5.586 score on a scale | Standard Deviation 13.8352 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -17.033 score on a scale | Standard Deviation 11.3561 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -13.517 score on a scale | Standard Deviation 12.9978 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -13.008 score on a scale | Standard Deviation 5.7949 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.667 score on a scale | Standard Deviation 5.8116 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 34.508 score on a scale | Standard Deviation 14.2748 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -12.792 score on a scale | Standard Deviation 8.4873 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -9.075 score on a scale | Standard Deviation 8.0323 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.917 score on a scale | Standard Deviation 10.6017 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -10.023 score on a scale | Standard Deviation 9.5951 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 28.431 score on a scale | Standard Deviation 11.1731 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.054 score on a scale | Standard Deviation 8.1006 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -8.062 score on a scale | Standard Deviation 10.212 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.023 score on a scale | Standard Deviation 12.2819 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.762 score on a scale | Standard Deviation 14.5004 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -12.708 score on a scale | Standard Deviation 15.0684 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -14.946 score on a scale | Standard Deviation 14.3229 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -13.708 score on a scale | Standard Deviation 15.368 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -12.169 score on a scale | Standard Deviation 15.7365 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -12.569 score on a scale | Standard Deviation 15.7788 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -11.438 score on a scale | Standard Deviation 15.7793 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -11.277 score on a scale | Standard Deviation 17.4198 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -11.685 score on a scale | Standard Deviation 15.4954 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -8.469 score on a scale | Standard Deviation 13.4793 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -9.577 score on a scale | Standard Deviation 14.5219 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -9.269 score on a scale | Standard Deviation 14.6406 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -8.677 score on a scale | Standard Deviation 14.0686 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -9.077 score on a scale | Standard Deviation 13.82 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -9.122 score on a scale | Standard Deviation 13.6836 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -14.964 score on a scale | Standard Deviation 15.3173 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -14.655 score on a scale | Standard Deviation 19.3982 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 33.745 score on a scale | Standard Deviation 17.7674 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -14.682 score on a scale | Standard Deviation 22.2529 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -15.073 score on a scale | Standard Deviation 20.5706 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -13.945 score on a scale | Standard Deviation 18.4699 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -11.373 score on a scale | Standard Deviation 16.1736 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -10.527 score on a scale | Standard Deviation 18.0938 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -13.109 score on a scale | Standard Deviation 19.0562 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -14.509 score on a scale | Standard Deviation 19.4841 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.382 score on a scale | Standard Deviation 11.9577 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -11.545 score on a scale | Standard Deviation 20.324 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -12.956 score on a scale | Standard Deviation 19.9469 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -13.945 score on a scale | Standard Deviation 20.3219 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.873 score on a scale | Standard Deviation 8.0467 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.827 score on a scale | Standard Deviation 18.8785 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -9.055 score on a scale | Standard Deviation 15.168 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -11.855 score on a scale | Standard Deviation 18.5106 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -13.809 score on a scale | Standard Deviation 12.3841 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -14.700 score on a scale | Standard Deviation 21.6976 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -9.285 score on a scale | Standard Deviation 19.7611 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -7.285 score on a scale | Standard Deviation 16.5677 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 33.069 score on a scale | Standard Deviation 11.7626 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -7.569 score on a scale | Standard Deviation 17.123 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -7.954 score on a scale | Standard Deviation 17.7855 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -8.708 score on a scale | Standard Deviation 19.9022 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -10.831 score on a scale | Standard Deviation 20.7975 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -8.600 score on a scale | Standard Deviation 19.1369 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -10.215 score on a scale | Standard Deviation 17.5279 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -10.985 score on a scale | Standard Deviation 21.6004 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -10.915 score on a scale | Standard Deviation 20.8181 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -9.731 score on a scale | Standard Deviation 19.3009 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -9.054 score on a scale | Standard Deviation 20.5279 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -10.369 score on a scale | Standard Deviation 20.2755 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -9.177 score on a scale | Standard Deviation 19.7402 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.815 score on a scale | Standard Deviation 14.7942 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -4.985 score on a scale | Standard Deviation 14.2086 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -8.446 score on a scale | Standard Deviation 15.4692 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -6.392 score on a scale | Standard Deviation 12.7832 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.362 score on a scale | Standard Deviation 9.6807 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -6.240 score on a scale | Standard Deviation 15.4074 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -10.890 score on a scale | Standard Deviation 14.0719 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -14.760 score on a scale | Standard Deviation 8.8873 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -7.060 score on a scale | Standard Deviation 15.2876 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -5.359 score on a scale | Standard Deviation 15.1614 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -11.230 score on a scale | Standard Deviation 13.3073 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.290 score on a scale | Standard Deviation 10.4209 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -13.080 score on a scale | Standard Deviation 9.0454 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -12.930 score on a scale | Standard Deviation 6.399 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.640 score on a scale | Standard Deviation 6.2285 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -11.670 score on a scale | Standard Deviation 12.957 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -6.820 score on a scale | Standard Deviation 16.7918 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -7.950 score on a scale | Standard Deviation 17.222 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -6.600 score on a scale | Standard Deviation 16.3039 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.790 score on a scale | Standard Deviation 6.416 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -5.180 score on a scale | Standard Deviation 14.742 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -7.780 score on a scale | Standard Deviation 16.2905 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -9.300 score on a scale | Standard Deviation 17.4237 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 29.060 score on a scale | Standard Deviation 6.675 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -8.480 score on a scale | Standard Deviation 15.8229 |
Secondary
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF
A total of 28 joints were examined for swollen joints. Swollen joints were marked with open circles in corresponding frames of the Assessment Sheet for Swollen Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -3.3 swollen joints | Standard Deviation 3.33 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -3.2 swollen joints | Standard Deviation 4.06 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -3.3 swollen joints | Standard Deviation 4.6 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -3.9 swollen joints | Standard Deviation 4.45 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 7.1 swollen joints | Standard Deviation 2.91 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -2.3 swollen joints | Standard Deviation 3.73 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -2.9 swollen joints | Standard Deviation 3.95 |
| Core Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.7 swollen joints | Standard Deviation 2.99 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -5.4 swollen joints | Standard Deviation 5.45 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -4.2 swollen joints | Standard Deviation 6.4 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -5.4 swollen joints | Standard Deviation 7.26 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.6 swollen joints | Standard Deviation 2.31 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 9.5 swollen joints | Standard Deviation 6.14 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.7 swollen joints | Standard Deviation 3.95 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -5.8 swollen joints | Standard Deviation 6.1 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -4.8 swollen joints | Standard Deviation 6.38 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -1.8 swollen joints | Standard Deviation 3.6 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 8.9 swollen joints | Standard Deviation 3.47 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -1.4 swollen joints | Standard Deviation 4.82 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -0.8 swollen joints | Standard Deviation 4.54 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -2.5 swollen joints | Standard Deviation 4.01 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.0 swollen joints | Standard Deviation 2.86 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -0.6 swollen joints | Standard Deviation 5.65 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -1.9 swollen joints | Standard Deviation 4.57 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.9 swollen joints | Standard Deviation 4.14 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -4.0 swollen joints | Standard Deviation 3.79 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -5.8 swollen joints | Standard Deviation 4.34 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -4.8 swollen joints | Standard Deviation 4.15 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -5.3 swollen joints | Standard Deviation 4.63 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -4.3 swollen joints | Standard Deviation 4.61 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 8.8 swollen joints | Standard Deviation 4.39 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -3.3 swollen joints | Standard Deviation 4.69 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -3.2 swollen joints | Standard Deviation 4.76 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.7 swollen joints | Standard Deviation 3.17 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -2.4 swollen joints | Standard Deviation 3.75 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -3.5 swollen joints | Standard Deviation 3.95 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -3.5 swollen joints | Standard Deviation 3.33 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -3.5 swollen joints | Standard Deviation 3.95 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -4.4 swollen joints | Standard Deviation 4.33 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -4.1 swollen joints | Standard Deviation 3.95 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -3.7 swollen joints | Standard Deviation 3.43 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -3.7 swollen joints | Standard Deviation 3.75 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -3.5 swollen joints | Standard Deviation 3.64 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -2.5 swollen joints | Standard Deviation 6.65 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -3.5 swollen joints | Standard Deviation 3.41 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -2.4 swollen joints | Standard Deviation 4.03 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -2.8 swollen joints | Standard Deviation 4.12 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -2.8 swollen joints | Standard Deviation 4.16 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -2.5 swollen joints | Standard Deviation 3.93 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -2.8 swollen joints | Standard Deviation 4.13 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -2.7 swollen joints | Standard Deviation 4.03 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 7.0 swollen joints | Standard Deviation 2.97 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -4.9 swollen joints | Standard Deviation 8.97 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -5.1 swollen joints | Standard Deviation 8.7 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -6.0 swollen joints | Standard Deviation 6.65 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -5.5 swollen joints | Standard Deviation 8.18 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -4.5 swollen joints | Standard Deviation 7.22 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -5.6 swollen joints | Standard Deviation 7.85 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -5.1 swollen joints | Standard Deviation 7.2 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -4.3 swollen joints | Standard Deviation 7.93 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -5.6 swollen joints | Standard Deviation 6.17 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -4.5 swollen joints | Standard Deviation 9.11 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -5.3 swollen joints | Standard Deviation 7.99 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -4.0 swollen joints | Standard Deviation 7.89 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -5.7 swollen joints | Standard Deviation 7.67 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.5 swollen joints | Standard Deviation 4.44 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -5.5 swollen joints | Standard Deviation 7.94 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.7 swollen joints | Standard Deviation 2.57 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -5.6 swollen joints | Standard Deviation 7.84 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 9.5 swollen joints | Standard Deviation 6.98 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -4.0 swollen joints | Standard Deviation 8.31 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -4.9 swollen joints | Standard Deviation 8.58 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -2.7 swollen joints | Standard Deviation 7.25 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -1.9 swollen joints | Standard Deviation 3.71 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -2.1 swollen joints | Standard Deviation 6.51 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -0.8 swollen joints | Standard Deviation 5.83 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.2 swollen joints | Standard Deviation 2.91 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -1.1 swollen joints | Standard Deviation 6.5 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -1.2 swollen joints | Standard Deviation 6.95 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -1.8 swollen joints | Standard Deviation 7 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -1.5 swollen joints | Standard Deviation 6.57 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -1.6 swollen joints | Standard Deviation 6.95 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -2.8 swollen joints | Standard Deviation 4.04 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 9.2 swollen joints | Standard Deviation 3.51 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -2.6 swollen joints | Standard Deviation 7.31 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -1.8 swollen joints | Standard Deviation 7.56 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -0.8 swollen joints | Standard Deviation 4.72 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -1.1 swollen joints | Standard Deviation 5.63 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -2.0 swollen joints | Standard Deviation 6.43 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -2.8 swollen joints | Standard Deviation 7.01 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -1.9 swollen joints | Standard Deviation 4.75 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -1.4 swollen joints | Standard Deviation 4.82 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -5.1 swollen joints | Standard Deviation 4.75 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.6 swollen joints | Standard Deviation 4.77 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -5.5 swollen joints | Standard Deviation 4.22 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 7.6 swollen joints | Standard Deviation 3.37 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -4.1 swollen joints | Standard Deviation 4.18 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -4.1 swollen joints | Standard Deviation 6.49 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -4.6 swollen joints | Standard Deviation 2.84 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -3.7 swollen joints | Standard Deviation 6.67 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -3.8 swollen joints | Standard Deviation 6.58 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -3.6 swollen joints | Standard Deviation 6.77 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -2.8 swollen joints | Standard Deviation 6.55 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -3.1 swollen joints | Standard Deviation 5.84 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -4.3 swollen joints | Standard Deviation 6.52 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -3.4 swollen joints | Standard Deviation 6.57 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -3.7 swollen joints | Standard Deviation 6.68 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -4.2 swollen joints | Standard Deviation 4.83 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -4.5 swollen joints | Standard Deviation 5.28 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -3.1 swollen joints | Standard Deviation 6.56 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -5.0 swollen joints | Standard Deviation 4.57 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.9 swollen joints | Standard Deviation 4.48 |
Secondary
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF)
A total of 28 joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Joints were examined for tenderness by applying pressure to the joint line or by moving joints through their respective ranges of motion. Tender joints were marked with tick or cross in corresponding frames of the Assessment Sheet for Tender Joint Counts. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. LOCF imputation was applied for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.8 tender joints | Standard Deviation 6.07 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -4.3 tender joints | Standard Deviation 6.65 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -5.1 tender joints | Standard Deviation 5.63 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.6 tender joints | Standard Deviation 3.92 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -3.3 tender joints | Standard Deviation 5.51 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 9.7 tender joints | Standard Deviation 6.88 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.7 tender joints | Standard Deviation 5.59 |
| Core Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -4.9 tender joints | Standard Deviation 6.06 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -4.1 tender joints | Standard Deviation 7.19 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 11.7 tender joints | Standard Deviation 7.74 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.1 tender joints | Standard Deviation 8.75 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -2.9 tender joints | Standard Deviation 8.89 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -3.7 tender joints | Standard Deviation 8.3 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -4.1 tender joints | Standard Deviation 5.17 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.9 tender joints | Standard Deviation 5.11 |
| Core Treatment Phase: E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.3 tender joints | Standard Deviation 3.41 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -2.3 tender joints | Standard Deviation 5.81 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.9 tender joints | Standard Deviation 4.48 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.6 tender joints | Standard Deviation 6.06 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -2.9 tender joints | Standard Deviation 6.46 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -2.0 tender joints | Standard Deviation 6.11 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.9 tender joints | Standard Deviation 6.18 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.9 tender joints | Standard Deviation 5.73 |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 9.9 tender joints | Standard Deviation 4.8 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -8.2 tender joints | Standard Deviation 7.3 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -4.4 tender joints | Standard Deviation 5.52 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -5.1 tender joints | Standard Deviation 6.16 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 12.8 tender joints | Standard Deviation 7.58 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -5.8 tender joints | Standard Deviation 3.05 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -6.2 tender joints | Standard Deviation 3.86 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -7.5 tender joints | Standard Deviation 6.97 |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -7.8 tender joints | Standard Deviation 8.07 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -4.6 tender joints | Standard Deviation 6.64 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 8.7 tender joints | Standard Deviation 4.85 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -3.5 tender joints | Standard Deviation 5.91 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -3.7 tender joints | Standard Deviation 7.16 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -4.5 tender joints | Standard Deviation 7.15 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -2.8 tender joints | Standard Deviation 6.72 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -3.2 tender joints | Standard Deviation 6.48 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -5.2 tender joints | Standard Deviation 6.48 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -3.8 tender joints | Standard Deviation 7.16 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -4.5 tender joints | Standard Deviation 7.17 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -2.0 tender joints | Standard Deviation 4.06 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.8 tender joints | Standard Deviation 6.88 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -2.8 tender joints | Standard Deviation 6.8 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -4.2 tender joints | Standard Deviation 7.32 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -2.8 tender joints | Standard Deviation 6.65 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -5.5 tender joints | Standard Deviation 5.99 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -2.5 tender joints | Standard Deviation 6.83 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -4.7 tender joints | Standard Deviation 7.04 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -2.6 tender joints | Standard Deviation 6.79 |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -3.1 tender joints | Standard Deviation 5.92 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -5.8 tender joints | Standard Deviation 9.9 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 11.6 tender joints | Standard Deviation 8.67 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -1.3 tender joints | Standard Deviation 3.77 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -3.1 tender joints | Standard Deviation 5.74 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -3.8 tender joints | Standard Deviation 9.72 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -3.5 tender joints | Standard Deviation 9.05 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -4.9 tender joints | Standard Deviation 7.82 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -3.9 tender joints | Standard Deviation 9.81 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -5.0 tender joints | Standard Deviation 8.93 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -5.1 tender joints | Standard Deviation 8.56 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -5.5 tender joints | Standard Deviation 9.37 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -6.3 tender joints | Standard Deviation 10.25 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -4.5 tender joints | Standard Deviation 7.33 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -2.6 tender joints | Standard Deviation 6.41 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -4.6 tender joints | Standard Deviation 8.03 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -5.5 tender joints | Standard Deviation 9.03 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -4.8 tender joints | Standard Deviation 5.38 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -4.5 tender joints | Standard Deviation 10.32 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -3.9 tender joints | Standard Deviation 9.08 |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -5.5 tender joints | Standard Deviation 8.99 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -2.9 tender joints | Standard Deviation 8.2 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -2.6 tender joints | Standard Deviation 5.84 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -2.0 tender joints | Standard Deviation 4.65 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -3.5 tender joints | Standard Deviation 7.61 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -1.8 tender joints | Standard Deviation 6.3 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -4.1 tender joints | Standard Deviation 8.27 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -2.5 tender joints | Standard Deviation 6.29 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -3.6 tender joints | Standard Deviation 7.89 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -1.3 tender joints | Standard Deviation 6.06 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 9.5 tender joints | Standard Deviation 4.75 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -1.8 tender joints | Standard Deviation 5.8 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -3.8 tender joints | Standard Deviation 7.93 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -3.2 tender joints | Standard Deviation 7.72 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -2.4 tender joints | Standard Deviation 7.54 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -3.5 tender joints | Standard Deviation 8.33 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -2.8 tender joints | Standard Deviation 8 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -2.8 tender joints | Standard Deviation 6.72 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.9 tender joints | Standard Deviation 7.71 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -3.5 tender joints | Standard Deviation 8.42 |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -3.5 tender joints | Standard Deviation 8.12 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -6.5 tender joints | Standard Deviation 5.72 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -4.4 tender joints | Standard Deviation 8.29 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -3.0 tender joints | Standard Deviation 4.83 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -4.4 tender joints | Standard Deviation 7.52 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -4.1 tender joints | Standard Deviation 7.05 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -4.5 tender joints | Standard Deviation 8.1 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -4.1 tender joints | Standard Deviation 6.72 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -4.1 tender joints | Standard Deviation 7.46 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -5.3 tender joints | Standard Deviation 6.52 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -3.9 tender joints | Standard Deviation 5.92 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -4.7 tender joints | Standard Deviation 4.69 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -6.3 tender joints | Standard Deviation 4.16 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -4.5 tender joints | Standard Deviation 7.74 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -6.1 tender joints | Standard Deviation 4.2 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -5.2 tender joints | Standard Deviation 2.97 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -6.2 tender joints | Standard Deviation 6.89 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -4.9 tender joints | Standard Deviation 6.94 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -2.9 tender joints | Standard Deviation 6.72 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 10.3 tender joints | Standard Deviation 5.1 |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -4.5 tender joints | Standard Deviation 7.59 |
Secondary
Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count-CRP based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \<=5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 2 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 3 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 1 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 2 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 14 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 9 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 6 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 3 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 10 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 6 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 4 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 4 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 1 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 9 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 3 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 8 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 6 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 4 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 0 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 10 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 1 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 9 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 2 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 7 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 5 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 13 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 9 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 9 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 8 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 9 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 10 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 9 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 9 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 11 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 7 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 3 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 6 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 8 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 6 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 9 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 12 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 9 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 0 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 4 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 4 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 8 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 8 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 10 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 8 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 9 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 10 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 9 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 9 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a EULAR Good, Moderate or No Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 4 Participants |
Secondary
Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 \<=3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to \<=5.1 or change from baseline \>0.6 to \<=1.2 with DAS28 \<=5.1; non-responders: change from baseline \<=0.6 or change from baseline \>0.6 and \<=1.2 with DAS28 \>5.1. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 1 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 4 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 1 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 3 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 2 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 8 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 5 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 13 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 9 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 2 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 3 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 10 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 8 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 3 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 7 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 5 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 2 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 4 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 5 Participants |
| Core Treatment Phase: Placebo | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 1 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 7 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 6 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 8 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 1 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 8 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 10 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 6 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 8 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 8 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 10 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 9 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 8 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 9 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 7 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 1 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 7 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 7 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 6 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 2 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 8 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 7 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 5 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 4 Participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 11 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 9 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | No Response | 4 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 9 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Moderate Response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | No Response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Moderate Response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | No Response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Good Response | 3 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Moderate Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Moderate Response | 8 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | No Response | 4 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Moderate Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Moderate Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Moderate Response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Moderate Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Good Response | 0 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Moderate Response | 7 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | No Response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 8 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 7 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Good Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Moderate Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | No Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Good Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Moderate Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Good Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Moderate Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Good Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Moderate Response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Good Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Moderate Response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Good Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Moderate Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Good Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Moderate Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Good Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Moderate Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | No Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 5 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Good Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 8 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 3 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 0 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 6 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Good Response | 2 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 1 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 4 Participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Moderate Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Moderate Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | No Response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Moderate Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | No Response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Moderate Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Moderate Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | No Response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 9 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Moderate Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 9 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | No Response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | No Response | 8 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Moderate Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | No Response | 9 Participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | No Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Moderate Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Moderate Response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | No Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Moderate Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Moderate Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 36 | No Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Moderate Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | No Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 64 | Moderate Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | No Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | No Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | No Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 40 | No Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Good Response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 4 | Good Response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | No Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | No Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | No Response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | No Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 44 | No Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | No Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 16 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | No Response | 6 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Moderate Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 28 | Good Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 20 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 60 | Good Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 56 | Moderate Response | 3 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 48 | No Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 24 | Moderate Response | 5 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 52 | Good Response | 1 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 68 | Moderate Response | 2 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 12 | Good Response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 2 | Moderate Response | 4 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 72 | No Response | 7 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 8 | Good Response | 0 Participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR Response at Week 32 | Good Response | 3 Participants |
Secondary
Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR20 response was defined as if the following 3 criteria (ACR components) were met: \>=20% reduction from baseline in the TJC in 68 joints (TJC68); \>=20% reduction from baseline in the SJC in 66 joints (SJC66); \>=20% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 16, 20, 24; Extension Phase: Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 26.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 13.3 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 20.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 13.3 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 46.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 46.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 28.6 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 28.6 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 28.6 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 28.6 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 35.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 28.6 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 28.6 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 21.4 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 42.9 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 35.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 50.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 33.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 50.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 25.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 25.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 46.2 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 61.5 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 61.5 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 53.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 38.5 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 53.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 46.2 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 46.2 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 38.5 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 38.5 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 30.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 53.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 53.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 53.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 61.5 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 36.4 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 36.4 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 54.5 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 45.5 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 45.5 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 36.4 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 54.5 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 45.5 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 36.4 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 36.4 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 45.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 46.2 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 53.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 53.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 46.2 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 23.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 38.5 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 53.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 50.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 40.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 50.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 30.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 30.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 50.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 60.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 50.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 40.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 30.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 50.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 40.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR50 response was defined as if the following 3 criteria (ACR components) were met: \>=50% reduction from baseline in the TJC in 68 joints (TJC68); \>=50% reduction from baseline in the SJC in 66 joints (SJC66); \>=50% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 20.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 20.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 14.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 14.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 16.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 16.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 16.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 16.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 30.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 30.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 30.8 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 23.1 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 27.3 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 23.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 23.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 23.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 23.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 30.8 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 23.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 30.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 10.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI
The ACR70 response was defined as if the following 3 criteria (ACR components) were met: \>=70% reduction from baseline in the TJC in 68 joints (TJC68); \>=70% reduction from baseline in the SJC in 66 joints (SJC66); \>=70% reduction from baseline in at least 3 of the following 5 assessments: Physician's Global Assessment of Disease Activity (VAS), Participant's Global Assessment of Disease Activity (VAS), Participant's Assessment of Pain (VAS), HAQ-DI, and CRP. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 18.2 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 44 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 36 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 52 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 20 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 72 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 60 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 68 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 56 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 24 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 12 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 40 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 28 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 64 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 48 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 32 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72 Based on NRI | Response at Week 16 | 0.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI
Boolean remission criteria was defined as: tender joint count 68 \<=1; swollen joint count 66 \<=1; CRP \<=1 mg/dL; and disease activity assessments VAS (mm) by participants \<=10. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 13.3 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 6.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 36 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 15.4 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 32 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 48 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 36 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 32 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 48 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 9.1 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 32 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 36 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 48 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 32 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 36 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 48 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 10.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI
The CDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), and physician global assessment of disease activity score (score range as 0-10). Total score ranged between 0-76. CDAI score of 76 or above=high disease activity, a value \>10 and \<=22=moderate disease activity, a value \>2.9 and \<=10=low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score \<=2.8. Data for the Core Treatment Phase from Week 0-10 is reported according to the participant's re-randomization in four arms at Week 12. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Core Treatment Phase, but excluding the participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 6.7 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 10.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI
The SDAI was calculated from tender joint counts of 28 (score range as 0-28), swollen joint counts of 28 (score range as 0-28), participant's global assessment of disease activity (score range as 0-10), physician global assessment of disease activity score (score range as 0-10), and CRP value (score range as 0-10). Total score ranged between 0-86. SDAI score of 86 or above=high disease activity, a value \>11 and \<=26=moderate disease activity, a value \>=3.4 and \<=11=low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score \<=3.3. Data for Core Treatment Phase from Week 0-10 is reported according to participant's re-randomization in four arms at Week 12. Data reported for Extension Phase from Week 2 to Week 24, is same data for Core Treatment Phase, but excluding participants who received at least 1 dose of study drug after Week 24 and had at least 1 postdose primary efficacy measurement after Week 24 to Week 72.
Time frame: Core Treatment Phase: Weeks 2, 4, 8, 12, 16, 20 and 24; Extension Phase: Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68 and 72
Population: FAS included all re-randomized participants who received at least 1 dose of study drug, and had at least 1 primary efficacy measurement. Here number analyzed n were the participants who were evaluable for the outcome measure for given time points. Non-responders (due to early discontinuation or other reasons were considered non-responders) imputation was applied for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 6.7 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.1 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 8.3 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Core Treatment Phase: E6011 400 mg Then E6011 400 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.7 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 27.3 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 9.1 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 18.2 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: Placebo Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 27.3 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 15.4 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 200 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 7.7 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 0.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 10.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 20.0 percentage of participants |
| Extension Phase: E6011 400 mg Then E6011 400 mg Then E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 10.0 percentage of participants |