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 methotrexate.
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 greater than or equal to (\>=) 18 and less than (\<)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 methotrexate (MTX) treatment at 6 to 16 milligram (mg)/week for \>=12 weeks before screening and 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 MTX at 6 to 16 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 * Erosions at \>=3 sites in radiographic image in the Screening Phase, or those with erosions at \>=1 site and either positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (CCP) antibody 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 (example, 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 (example, 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®TB Gold Test or T-SPOT®.TB 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 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 |
|---|---|---|
| Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) 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 |
|---|---|---|
| Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Weeks 2, 4, 8, 16, 20, and 24 | 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. |
| Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Weeks 2, 4, 8, 16, 20, and 24 | 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. |
| Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | 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, 72, 76, 80, and 84 | A total of 68 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | A total of 66 joints (minus 2 hip joints from evaluated tender 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | 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. 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | The degree of disability was self-evaluated by the participant using the HAQ-DI. The assessment was made based on the activities capable without any aids or devices. The 20-question instrument assessed the degree of difficulty a 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 a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | CRP of each participants was measured as a part of blood biochemical tests. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | 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, 72, 76, 80,and 84 | ESR were a type of blood test. An ESR was used to monitor the arthritis condition. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Weeks 2, 4, 8, 16, 20, and 24 | 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. |
| Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | 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 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \<2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | The SDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-86. SDAI score of 26 or above = high disease activity, a value between 11 and 26 = moderate disease activity and value less than or equal to (\<=) 11 = low disease activity, value \<=33 = disease remission. Higher scores indicated higher disease activity. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | The CDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-76. CDAI score of 22 or above = high disease activity, a value between 10 and 22 = moderate disease activity and value less than or equal to \<=10 = low disease activity, value \<=2.8 = disease remission. Higher scores indicated higher disease activity. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | Treatment Phase: 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, 72, 76, 80, and 84 | The Disease Activity Score Based on 28-joints Count 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 reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | Treatment Phase: 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, 72, 76, 80, and 84 | The Disease Activity Score Based on 28-joints Count 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 reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Treatment Phase: 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, 72, 76, 80, 84, 88, 92, 96, 100, and 104 | The SDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-86. SDAI score of 26 or above = high disease activity, a value between 11 and 26 = moderate disease activity and value \<=11 = low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score \<=3.3. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | 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, 72, 76, 80, and 84 | The CDAI was calculated from tender joint counts of 28, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-76. CDAI score of 22 or above = high disease activity, a value between 10 and 22 = moderate disease activity and value less than or equal to \<=10 = low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score \<=2.8. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | 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, 72, 76, 80, and 84 | Boolean remission criteria was defined as: tender joint count 68 \<=1; swollen joint count 68 \<=1; CRP \<=1 mg/dL; and disease activity assessments VAS (mm) by participants \<=1. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Treatment Phase: Baseline and Week 24; Extension Phase: Baseline, Weeks 24, 52, 76, and 104 | The mTSS was a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \[normal\] to 528 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of \<=0.5. Data reported for the Extension Phase from Baseline and Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
| Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | 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, 72, 76, 80, and 84 | 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 between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \<2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 91 investigative sites in Japan from 20 October 2016 to 17 September 2019.
Pre-assignment details
A total of 273 participants were screened and enrolled (signed informed consent form), of which 79 were screen failures, and 194 were randomized out which 190 received study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo During Treatment Phase, participants received E6011-matched placebo, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102. | 54 |
| E6011 100 mg During Treatment Phase, participants received E6011 100 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102. | 28 |
| E6011 200 mg During Treatment Phase, participants received E6011 200 mg, infusion, subcutaneously, at Weeks 0, 1, and 2 and then every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102. | 54 |
| E6011 400/200 mg During Treatment Phase, participants received E6011 400 mg, infusion, subcutaneously, at Weeks 0, 1, 4, 6, 8, 10 and then E6011 200 mg, infusion, subcutaneously, every 2 weeks up to Week 22. Following completion of evaluations of the Treatment Phase at Week 24, participants entered the Extension Phase and received E6011 200 mg, infusion, subcutaneously, every 2 weeks until Week 102. | 54 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Extension Phase (Open-label): 80 Weeks | Adverse Event | 1 | 2 | 4 | 1 |
| Extension Phase (Open-label): 80 Weeks | Inadequate Therapeutic Effect | 7 | 5 | 7 | 6 |
| Extension Phase (Open-label): 80 Weeks | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Extension Phase (Open-label): 80 Weeks | Other | 0 | 0 | 1 | 1 |
| Extension Phase (Open-label): 80 Weeks | Progression of Disease | 2 | 1 | 1 | 2 |
| Extension Phase (Open-label): 80 Weeks | Withdrawal by Subject | 1 | 1 | 0 | 1 |
| Treatment Phase (Double-blind): 24 Weeks | Adverse Event | 2 | 1 | 0 | 3 |
| Treatment Phase (Double-blind): 24 Weeks | Inadequate Therapeutic Effect | 2 | 1 | 2 | 5 |
| Treatment Phase (Double-blind): 24 Weeks | Not Treated | 2 | 1 | 0 | 1 |
| Treatment Phase (Double-blind): 24 Weeks | Other | 0 | 0 | 1 | 0 |
| Treatment Phase (Double-blind): 24 Weeks | Progression of Disease | 2 | 0 | 0 | 0 |
| Treatment Phase (Double-blind): 24 Weeks | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | E6011 100 mg | E6011 200 mg | E6011 400/200 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 9.86 | 56.5 years STANDARD_DEVIATION 10.4 | 56.5 years STANDARD_DEVIATION 10.39 | 55.2 years STANDARD_DEVIATION 9.13 | 56.4 years STANDARD_DEVIATION 9.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 28 Participants | 54 Participants | 54 Participants | 190 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Japanese | 54 Participants | 28 Participants | 54 Participants | 54 Participants | 190 Participants |
| Sex: Female, Male Female | 45 Participants | 22 Participants | 44 Participants | 39 Participants | 150 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 10 Participants | 15 Participants | 40 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 |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 28 | 0 / 54 | 0 / 54 | 0 / 47 | 0 / 26 | 0 / 50 | 0 / 46 |
| other Total, other adverse events | 34 / 54 | 19 / 28 | 38 / 54 | 43 / 54 | 46 / 47 | 26 / 26 | 50 / 50 | 45 / 46 |
| serious Total, serious adverse events | 2 / 54 | 1 / 28 | 2 / 54 | 3 / 54 | 4 / 47 | 1 / 26 | 7 / 50 | 6 / 46 |
Outcome results
Primary
Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) 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 was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) Response at Week 12 Based on Non-responder Imputation (NRI) | 37.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) Response at Week 12 Based on Non-responder Imputation (NRI) | 39.3 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) Response at Week 12 Based on Non-responder Imputation (NRI) | 48.1 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an American College of Rheumatology 20 (ACR20) Response at Week 12 Based on Non-responder Imputation (NRI) | 46.3 percentage of participants |
p-value: 0.37495% CI: [-19.96, 24.46]Regression, Logistic
p-value: 0.10295% CI: [-7.42, 29.64]Regression, Logistic
p-value: 0.18895% CI: [-9.25, 27.77]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, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-76. CDAI score of 22 or above = high disease activity, a value between 10 and 22 = moderate disease activity and value less than or equal to \<=10 = low disease activity, value \<=2.8 = disease remission. Higher scores indicated higher disease activity. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.700 score on a scale | Standard Deviation 12.4359 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -9.469 score on a scale | Standard Deviation 12.5253 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -9.231 score on a scale | Standard Deviation 14.0979 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.007 score on a scale | Standard Deviation 7.9447 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -5.787 score on a scale | Standard Deviation 8.3763 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -7.456 score on a scale | Standard Deviation 11.9815 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -9.080 score on a scale | Standard Deviation 13.2957 |
| Treatment Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 29.198 score on a scale | Standard Deviation 10.1188 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -12.279 score on a scale | Standard Deviation 10.359 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.786 score on a scale | Standard Deviation 10.2476 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 29.104 score on a scale | Standard Deviation 11.3057 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -5.093 score on a scale | Standard Deviation 6.9306 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.336 score on a scale | Standard Deviation 6.0158 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -12.411 score on a scale | Standard Deviation 10.6684 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.900 score on a scale | Standard Deviation 10.741 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -7.754 score on a scale | Standard Deviation 8.3585 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.785 score on a scale | Standard Deviation 6.8641 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -7.983 score on a scale | Standard Deviation 7.0449 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -14.815 score on a scale | Standard Deviation 11.3164 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 30.563 score on a scale | Standard Deviation 9.326 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -13.548 score on a scale | Standard Deviation 11.4067 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -13.698 score on a scale | Standard Deviation 9.5039 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -9.824 score on a scale | Standard Deviation 9.4091 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -12.391 score on a scale | Standard Deviation 9.5546 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.243 score on a scale | Standard Deviation 14.049 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -13.335 score on a scale | Standard Deviation 13.752 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.424 score on a scale | Standard Deviation 9.5389 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -10.152 score on a scale | Standard Deviation 10.7576 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -15.361 score on a scale | Standard Deviation 14.0888 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -12.809 score on a scale | Standard Deviation 12.4854 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 33.169 score on a scale | Standard Deviation 12.022 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -15.113 score on a scale | Standard Deviation 14.318 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -14.981 score on a scale | Standard Deviation 11.8964 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -14.687 score on a scale | Standard Deviation 13.6997 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -13.440 score on a scale | Standard Deviation 12.6798 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.640 score on a scale | Standard Deviation 6.8069 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -13.977 score on a scale | Standard Deviation 14.2191 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -14.032 score on a scale | Standard Deviation 12.9707 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -13.577 score on a scale | Standard Deviation 13.4474 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -14.019 score on a scale | Standard Deviation 12.9269 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -14.679 score on a scale | Standard Deviation 13.9556 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -6.421 score on a scale | Standard Deviation 7.7106 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -9.364 score on a scale | Standard Deviation 9.0361 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 28.900 score on a scale | Standard Deviation 9.9333 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -14.091 score on a scale | Standard Deviation 14.0501 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.666 score on a scale | Standard Deviation 9.4769 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.853 score on a scale | Standard Deviation 9.2509 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -14.536 score on a scale | Standard Deviation 13.4853 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -11.857 score on a scale | Standard Deviation 11.3698 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -11.683 score on a scale | Standard Deviation 10.2413 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -14.536 score on a scale | Standard Deviation 13.7461 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -13.753 score on a scale | Standard Deviation 11.1661 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -15.291 score on a scale | Standard Deviation 13.2786 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -13.917 score on a scale | Standard Deviation 13.0248 |
| Extension Phase: Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -14.226 score on a scale | Standard Deviation 13.3556 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -14.346 score on a scale | Standard Deviation 10.9159 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -7.704 score on a scale | Standard Deviation 8.2942 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -15.565 score on a scale | Standard Deviation 10.789 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -4.904 score on a scale | Standard Deviation 6.6827 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -14.462 score on a scale | Standard Deviation 10.8608 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -14.315 score on a scale | Standard Deviation 10.3937 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -13.004 score on a scale | Standard Deviation 10.5902 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -14.031 score on a scale | Standard Deviation 10.7633 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -14.015 score on a scale | Standard Deviation 10.449 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -14.058 score on a scale | Standard Deviation 10.6267 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -14.519 score on a scale | Standard Deviation 11.5712 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.142 score on a scale | Standard Deviation 6.0961 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -13.958 score on a scale | Standard Deviation 12.008 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -14.658 score on a scale | Standard Deviation 11.0874 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -15.108 score on a scale | Standard Deviation 11.2046 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -15.400 score on a scale | Standard Deviation 10.4881 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -12.273 score on a scale | Standard Deviation 10.1616 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -14.600 score on a scale | Standard Deviation 10.424 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 29.196 score on a scale | Standard Deviation 11.7439 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -10.177 score on a scale | Standard Deviation 10.7463 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -15.150 score on a scale | Standard Deviation 10.5316 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -12.862 score on a scale | Standard Deviation 10.2616 |
| Extension Phase: E6011 100 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -15.031 score on a scale | Standard Deviation 10.8769 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -15.476 score on a scale | Standard Deviation 11.0172 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 29.918 score on a scale | Standard Deviation 8.2741 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.518 score on a scale | Standard Deviation 6.7345 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -8.080 score on a scale | Standard Deviation 6.8543 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -9.946 score on a scale | Standard Deviation 9.3095 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -13.012 score on a scale | Standard Deviation 8.9533 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.220 score on a scale | Standard Deviation 9.118 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -14.108 score on a scale | Standard Deviation 11.1938 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -16.604 score on a scale | Standard Deviation 11.5179 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -15.606 score on a scale | Standard Deviation 12.5181 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -17.134 score on a scale | Standard Deviation 10.9034 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -16.980 score on a scale | Standard Deviation 9.3329 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -17.060 score on a scale | Standard Deviation 9.89 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -16.884 score on a scale | Standard Deviation 11.0023 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -16.764 score on a scale | Standard Deviation 9.4282 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -16.228 score on a scale | Standard Deviation 10.8175 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -16.592 score on a scale | Standard Deviation 11.8366 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -15.924 score on a scale | Standard Deviation 11.5956 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -16.422 score on a scale | Standard Deviation 11.7994 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -16.828 score on a scale | Standard Deviation 11.2797 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -17.556 score on a scale | Standard Deviation 11.5861 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -17.090 score on a scale | Standard Deviation 11.0248 |
| Extension Phase: E6011 200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -17.344 score on a scale | Standard Deviation 11.2309 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -20.450 score on a scale | Standard Deviation 13.8226 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -20.139 score on a scale | Standard Deviation 13.4967 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -20.215 score on a scale | Standard Deviation 12.0216 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -18.478 score on a scale | Standard Deviation 13.6585 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -18.700 score on a scale | Standard Deviation 13.213 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -20.420 score on a scale | Standard Deviation 12.9597 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -20.917 score on a scale | Standard Deviation 12.3462 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -18.000 score on a scale | Standard Deviation 12.858 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -17.487 score on a scale | Standard Deviation 13.3908 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.663 score on a scale | Standard Deviation 9.957 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -20.063 score on a scale | Standard Deviation 12.2151 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -16.541 score on a scale | Standard Deviation 13.2391 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -14.617 score on a scale | Standard Deviation 14.3068 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Baseline | 32.848 score on a scale | Standard Deviation 11.4735 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -20.289 score on a scale | Standard Deviation 11.8557 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -19.076 score on a scale | Standard Deviation 12.7465 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -13.778 score on a scale | Standard Deviation 13.1305 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -20.167 score on a scale | Standard Deviation 12.7089 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -19.624 score on a scale | Standard Deviation 13.4005 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -19.941 score on a scale | Standard Deviation 14.6274 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -10.713 score on a scale | Standard Deviation 11.3327 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -20.354 score on a scale | Standard Deviation 12.8739 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Clinical Disease Activity Index (CDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -19.274 score on a scale | Standard Deviation 13.4909 |
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. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.21 milligram per deciliter (mg/dL) | Standard Deviation 1.192 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.06 milligram per deciliter (mg/dL) | Standard Deviation 1.235 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.09 milligram per deciliter (mg/dL) | Standard Deviation 0.909 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.15 milligram per deciliter (mg/dL) | Standard Deviation 1.503 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.39 milligram per deciliter (mg/dL) | Standard Deviation 2.063 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.50 milligram per deciliter (mg/dL) | Standard Deviation 1.633 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.24 milligram per deciliter (mg/dL) | Standard Deviation 1.686 |
| Treatment Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.17 milligram per deciliter (mg/dL) | Standard Deviation 1.429 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.26 milligram per deciliter (mg/dL) | Standard Deviation 1.626 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.12 milligram per deciliter (mg/dL) | Standard Deviation 1.75 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.20 milligram per deciliter (mg/dL) | Standard Deviation 1.279 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | -0.26 milligram per deciliter (mg/dL) | Standard Deviation 1.887 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.17 milligram per deciliter (mg/dL) | Standard Deviation 1.683 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.23 milligram per deciliter (mg/dL) | Standard Deviation 1.429 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.44 milligram per deciliter (mg/dL) | Standard Deviation 1.868 |
| Treatment Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.28 milligram per deciliter (mg/dL) | Standard Deviation 1.148 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.08 milligram per deciliter (mg/dL) | Standard Deviation 0.84 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.29 milligram per deciliter (mg/dL) | Standard Deviation 1.407 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.01 milligram per deciliter (mg/dL) | Standard Deviation 1.155 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.18 milligram per deciliter (mg/dL) | Standard Deviation 1.071 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.11 milligram per deciliter (mg/dL) | Standard Deviation 1.214 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.06 milligram per deciliter (mg/dL) | Standard Deviation 1.263 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.04 milligram per deciliter (mg/dL) | Standard Deviation 0.707 |
| Treatment Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.08 milligram per deciliter (mg/dL) | Standard Deviation 0.707 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.24 milligram per deciliter (mg/dL) | Standard Deviation 1.634 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.07 milligram per deciliter (mg/dL) | Standard Deviation 0.777 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.33 milligram per deciliter (mg/dL) | Standard Deviation 1.383 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | -0.03 milligram per deciliter (mg/dL) | Standard Deviation 1.343 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.05 milligram per deciliter (mg/dL) | Standard Deviation 1.403 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.09 milligram per deciliter (mg/dL) | Standard Deviation 1.737 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.01 milligram per deciliter (mg/dL) | Standard Deviation 1.332 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.38 milligram per deciliter (mg/dL) | Standard Deviation 2.22 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 80 | -0.20 milligram per deciliter (mg/dL) | Standard Deviation 2.297 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | -0.14 milligram per deciliter (mg/dL) | Standard Deviation 1.134 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 84 | -0.23 milligram per deciliter (mg/dL) | Standard Deviation 2.332 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | -0.04 milligram per deciliter (mg/dL) | Standard Deviation 2.062 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | 0.01 milligram per deciliter (mg/dL) | Standard Deviation 1.485 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.42 milligram per deciliter (mg/dL) | Standard Deviation 1.682 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | -0.09 milligram per deciliter (mg/dL) | Standard Deviation 1.967 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | 0.00 milligram per deciliter (mg/dL) | Standard Deviation 1.412 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 76 | -0.09 milligram per deciliter (mg/dL) | Standard Deviation 2.382 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | 0.33 milligram per deciliter (mg/dL) | Standard Deviation 2.13 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | -0.13 milligram per deciliter (mg/dL) | Standard Deviation 1.956 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | -0.17 milligram per deciliter (mg/dL) | Standard Deviation 1.852 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | 0.00 milligram per deciliter (mg/dL) | Standard Deviation 1.652 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.16 milligram per deciliter (mg/dL) | Standard Deviation 0.93 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | 0.14 milligram per deciliter (mg/dL) | Standard Deviation 1.91 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.18 milligram per deciliter (mg/dL) | Standard Deviation 2.106 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | -0.17 milligram per deciliter (mg/dL) | Standard Deviation 2.414 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | -0.24 milligram per deciliter (mg/dL) | Standard Deviation 1.792 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | -0.10 milligram per deciliter (mg/dL) | Standard Deviation 2.067 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | -0.10 milligram per deciliter (mg/dL) | Standard Deviation 1.939 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | -0.26 milligram per deciliter (mg/dL) | Standard Deviation 2.207 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | -0.10 milligram per deciliter (mg/dL) | Standard Deviation 1.839 |
| Extension Phase: Placebo | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.04 milligram per deciliter (mg/dL) | Standard Deviation 1.103 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | -0.27 milligram per deciliter (mg/dL) | Standard Deviation 2.167 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | -0.25 milligram per deciliter (mg/dL) | Standard Deviation 2.131 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | -0.32 milligram per deciliter (mg/dL) | Standard Deviation 1.617 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | -0.14 milligram per deciliter (mg/dL) | Standard Deviation 2.375 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | -0.30 milligram per deciliter (mg/dL) | Standard Deviation 1.801 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.26 milligram per deciliter (mg/dL) | Standard Deviation 1.481 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.15 milligram per deciliter (mg/dL) | Standard Deviation 1.268 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 76 | -0.38 milligram per deciliter (mg/dL) | Standard Deviation 2.115 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | -0.35 milligram per deciliter (mg/dL) | Standard Deviation 1.924 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | -0.44 milligram per deciliter (mg/dL) | Standard Deviation 2.001 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | -0.32 milligram per deciliter (mg/dL) | Standard Deviation 1.176 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | -0.34 milligram per deciliter (mg/dL) | Standard Deviation 2.115 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | -0.35 milligram per deciliter (mg/dL) | Standard Deviation 1.908 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.29 milligram per deciliter (mg/dL) | Standard Deviation 1.684 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.41 milligram per deciliter (mg/dL) | Standard Deviation 1.901 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.08 milligram per deciliter (mg/dL) | Standard Deviation 1.787 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | -0.23 milligram per deciliter (mg/dL) | Standard Deviation 2.288 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 80 | -0.32 milligram per deciliter (mg/dL) | Standard Deviation 2.065 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | -0.34 milligram per deciliter (mg/dL) | Standard Deviation 1.603 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 84 | -0.39 milligram per deciliter (mg/dL) | Standard Deviation 2.097 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | -0.23 milligram per deciliter (mg/dL) | Standard Deviation 2.276 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.25 milligram per deciliter (mg/dL) | Standard Deviation 1.712 |
| Extension Phase: E6011 100 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | -0.13 milligram per deciliter (mg/dL) | Standard Deviation 2.311 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | -0.03 milligram per deciliter (mg/dL) | Standard Deviation 1.161 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.04 milligram per deciliter (mg/dL) | Standard Deviation 0.843 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.08 milligram per deciliter (mg/dL) | Standard Deviation 0.715 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.03 milligram per deciliter (mg/dL) | Standard Deviation 0.694 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | 0.28 milligram per deciliter (mg/dL) | Standard Deviation 1.452 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.07 milligram per deciliter (mg/dL) | Standard Deviation 1.309 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.10 milligram per deciliter (mg/dL) | Standard Deviation 1.249 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.23 milligram per deciliter (mg/dL) | Standard Deviation 1.06 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | -0.21 milligram per deciliter (mg/dL) | Standard Deviation 0.997 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | 0.13 milligram per deciliter (mg/dL) | Standard Deviation 1.585 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | -0.04 milligram per deciliter (mg/dL) | Standard Deviation 1.301 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | -0.10 milligram per deciliter (mg/dL) | Standard Deviation 1.1 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | 0.26 milligram per deciliter (mg/dL) | Standard Deviation 1.798 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | -0.04 milligram per deciliter (mg/dL) | Standard Deviation 1.103 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | -0.10 milligram per deciliter (mg/dL) | Standard Deviation 1.134 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | -0.03 milligram per deciliter (mg/dL) | Standard Deviation 1.264 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | -0.03 milligram per deciliter (mg/dL) | Standard Deviation 1.266 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | 0.54 milligram per deciliter (mg/dL) | Standard Deviation 4.066 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | 0.13 milligram per deciliter (mg/dL) | Standard Deviation 1.662 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | 0.04 milligram per deciliter (mg/dL) | Standard Deviation 1.55 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 76 | 0.07 milligram per deciliter (mg/dL) | Standard Deviation 1.593 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 80 | 0.02 milligram per deciliter (mg/dL) | Standard Deviation 1.524 |
| Extension Phase: E6011 200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 84 | 0.11 milligram per deciliter (mg/dL) | Standard Deviation 1.754 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 36 | -0.24 milligram per deciliter (mg/dL) | Standard Deviation 1.691 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 84 | -0.35 milligram per deciliter (mg/dL) | Standard Deviation 1.417 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 64 | -0.40 milligram per deciliter (mg/dL) | Standard Deviation 1.307 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 32 | -0.35 milligram per deciliter (mg/dL) | Standard Deviation 1.371 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 28 | -0.19 milligram per deciliter (mg/dL) | Standard Deviation 1.677 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 80 | -0.40 milligram per deciliter (mg/dL) | Standard Deviation 1.26 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 68 | -0.36 milligram per deciliter (mg/dL) | Standard Deviation 1.414 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 24 | 0.30 milligram per deciliter (mg/dL) | Standard Deviation 2.269 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 20 | -0.14 milligram per deciliter (mg/dL) | Standard Deviation 1.154 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 2 | 0.12 milligram per deciliter (mg/dL) | Standard Deviation 0.769 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 72 | -0.28 milligram per deciliter (mg/dL) | Standard Deviation 1.437 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 16 | -0.08 milligram per deciliter (mg/dL) | Standard Deviation 1.713 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 12 | -0.24 milligram per deciliter (mg/dL) | Standard Deviation 1.314 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Baseline | 1.07 milligram per deciliter (mg/dL) | Standard Deviation 1.291 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 76 | -0.41 milligram per deciliter (mg/dL) | Standard Deviation 1.329 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 52 | -0.14 milligram per deciliter (mg/dL) | Standard Deviation 1.162 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 8 | -0.15 milligram per deciliter (mg/dL) | Standard Deviation 1.392 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 56 | -0.27 milligram per deciliter (mg/dL) | Standard Deviation 1.124 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 48 | -0.32 milligram per deciliter (mg/dL) | Standard Deviation 1.416 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 44 | -0.17 milligram per deciliter (mg/dL) | Standard Deviation 1.47 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 4 | 0.28 milligram per deciliter (mg/dL) | Standard Deviation 1.443 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 60 | -0.39 milligram per deciliter (mg/dL) | Standard Deviation 1.276 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in C-reactive Protein (CRP) Values at Each Visit Based on LOCF | Change at Week 40 | -0.25 milligram per deciliter (mg/dL) | Standard Deviation 1.539 |
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 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \<2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.692 score on a scale | Standard Deviation 1.2057 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -0.913 score on a scale | Standard Deviation 1.2429 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -0.889 score on a scale | Standard Deviation 1.345 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.474 score on a scale | Standard Deviation 0.75 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.514 score on a scale | Standard Deviation 0.8858 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.607 score on a scale | Standard Deviation 1.064 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -0.825 score on a scale | Standard Deviation 1.3502 |
| Treatment Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.039 score on a scale | Standard Deviation 0.8789 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.186 score on a scale | Standard Deviation 1.0136 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.160 score on a scale | Standard Deviation 1.0453 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 4.993 score on a scale | Standard Deviation 1.0096 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.407 score on a scale | Standard Deviation 0.6521 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.464 score on a scale | Standard Deviation 0.5214 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.212 score on a scale | Standard Deviation 1.1955 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.028 score on a scale | Standard Deviation 1.0399 |
| Treatment Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.679 score on a scale | Standard Deviation 0.8212 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.531 score on a scale | Standard Deviation 0.6404 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.675 score on a scale | Standard Deviation 0.6705 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.449 score on a scale | Standard Deviation 1.1679 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.079 score on a scale | Standard Deviation 0.729 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.397 score on a scale | Standard Deviation 1.238 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.339 score on a scale | Standard Deviation 1.019 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.885 score on a scale | Standard Deviation 0.8535 |
| Treatment Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.206 score on a scale | Standard Deviation 1.0564 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.250 score on a scale | Standard Deviation 1.4208 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.164 score on a scale | Standard Deviation 1.3302 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.430 score on a scale | Standard Deviation 0.7393 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.704 score on a scale | Standard Deviation 0.9959 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.400 score on a scale | Standard Deviation 1.4462 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -1.059 score on a scale | Standard Deviation 1.1604 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.202 score on a scale | Standard Deviation 0.9283 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.437 score on a scale | Standard Deviation 1.444 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -1.438 score on a scale | Standard Deviation 1.2821 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -1.380 score on a scale | Standard Deviation 1.3475 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -1.286 score on a scale | Standard Deviation 1.2637 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.534 score on a scale | Standard Deviation 0.737 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -1.338 score on a scale | Standard Deviation 1.408 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -1.392 score on a scale | Standard Deviation 1.4082 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.293 score on a scale | Standard Deviation 1.4043 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -1.425 score on a scale | Standard Deviation 1.3826 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 84 | -1.524 score on a scale | Standard Deviation 1.5688 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.591 score on a scale | Standard Deviation 0.8735 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.767 score on a scale | Standard Deviation 0.9529 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 4.997 score on a scale | Standard Deviation 0.8561 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 80 | -1.438 score on a scale | Standard Deviation 1.529 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -0.855 score on a scale | Standard Deviation 1.0981 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.125 score on a scale | Standard Deviation 1.1056 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 76 | -1.445 score on a scale | Standard Deviation 1.5266 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.133 score on a scale | Standard Deviation 1.1959 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.058 score on a scale | Standard Deviation 1.2175 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -1.434 score on a scale | Standard Deviation 1.4852 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.363 score on a scale | Standard Deviation 1.2248 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -1.520 score on a scale | Standard Deviation 1.4072 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.319 score on a scale | Standard Deviation 1.2935 |
| Extension Phase: Placebo | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -1.343 score on a scale | Standard Deviation 1.317 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -1.398 score on a scale | Standard Deviation 1.124 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.684 score on a scale | Standard Deviation 0.7985 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 80 | -1.544 score on a scale | Standard Deviation 1.1475 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.391 score on a scale | Standard Deviation 0.6202 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -1.438 score on a scale | Standard Deviation 1.1264 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -1.359 score on a scale | Standard Deviation 1.1999 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.292 score on a scale | Standard Deviation 1.1959 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.407 score on a scale | Standard Deviation 1.155 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.329 score on a scale | Standard Deviation 1.2331 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -1.334 score on a scale | Standard Deviation 1.1039 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.386 score on a scale | Standard Deviation 1.2327 |
| Extension Phase: E6011 100 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 0.5043 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -1.414 score on a scale | Standard Deviation 1.2456 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -1.475 score on a scale | Standard Deviation 1.2492 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -1.461 score on a scale | Standard Deviation 1.1617 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -1.557 score on a scale | Standard Deviation 1.1507 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.222 score on a scale | Standard Deviation 1.042 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 76 | -1.489 score on a scale | Standard Deviation 1.1022 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 4.978 score on a scale | Standard Deviation 1.0458 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.071 score on a scale | Standard Deviation 1.0433 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -1.530 score on a scale | Standard Deviation 1.1474 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.264 score on a scale | Standard Deviation 1.0004 |
| Extension Phase: E6011 100 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 84 | -1.596 score on a scale | Standard Deviation 1.2642 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.518 score on a scale | Standard Deviation 1.1251 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.034 score on a scale | Standard Deviation 0.6676 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.514 score on a scale | Standard Deviation 0.6403 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.678 score on a scale | Standard Deviation 0.6539 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -0.905 score on a scale | Standard Deviation 0.8341 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.260 score on a scale | Standard Deviation 1.0062 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.385 score on a scale | Standard Deviation 0.9817 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.461 score on a scale | Standard Deviation 1.2066 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.645 score on a scale | Standard Deviation 1.249 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -1.545 score on a scale | Standard Deviation 1.4075 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.729 score on a scale | Standard Deviation 1.2139 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -1.688 score on a scale | Standard Deviation 1.0828 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -1.702 score on a scale | Standard Deviation 1.2073 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -1.658 score on a scale | Standard Deviation 1.1945 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.660 score on a scale | Standard Deviation 1.1057 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -1.603 score on a scale | Standard Deviation 1.2139 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -1.697 score on a scale | Standard Deviation 1.325 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -1.579 score on a scale | Standard Deviation 1.2837 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -1.627 score on a scale | Standard Deviation 1.3523 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -1.698 score on a scale | Standard Deviation 1.2813 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 76 | -1.783 score on a scale | Standard Deviation 1.2366 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 80 | -1.688 score on a scale | Standard Deviation 1.1779 |
| Extension Phase: E6011 200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 84 | -1.750 score on a scale | Standard Deviation 1.2376 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 36 | -1.910 score on a scale | Standard Deviation 1.4317 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 84 | -2.090 score on a scale | Standard Deviation 1.4318 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 64 | -2.039 score on a scale | Standard Deviation 1.2069 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 32 | -1.724 score on a scale | Standard Deviation 1.4062 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 28 | -1.770 score on a scale | Standard Deviation 1.3779 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 80 | -2.069 score on a scale | Standard Deviation 1.3821 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 68 | -2.092 score on a scale | Standard Deviation 1.2697 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 24 | -1.666 score on a scale | Standard Deviation 1.3715 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 20 | -1.692 score on a scale | Standard Deviation 1.3754 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 2 | -0.433 score on a scale | Standard Deviation 0.7731 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 72 | -1.946 score on a scale | Standard Deviation 1.3801 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 16 | -1.473 score on a scale | Standard Deviation 1.3859 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 12 | -1.321 score on a scale | Standard Deviation 1.3768 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Baseline | 5.138 score on a scale | Standard Deviation 0.8998 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 76 | -2.029 score on a scale | Standard Deviation 1.2583 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 52 | -1.815 score on a scale | Standard Deviation 1.2919 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 8 | -1.136 score on a scale | Standard Deviation 1.2236 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 56 | -1.999 score on a scale | Standard Deviation 1.3047 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 48 | -1.904 score on a scale | Standard Deviation 1.3723 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 44 | -1.915 score on a scale | Standard Deviation 1.5062 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 4 | -0.747 score on a scale | Standard Deviation 1.0501 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 60 | -2.015 score on a scale | Standard Deviation 1.3216 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in DAS28-CRP Values at Each Visit Based on LOCF | Change at Week 40 | -1.835 score on a scale | Standard Deviation 1.4415 |
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 between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value \<2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.763 score on a scale | Standard Deviation 1.2561 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.022 score on a scale | Standard Deviation 1.3026 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -0.977 score on a scale | Standard Deviation 1.3914 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.520 score on a scale | Standard Deviation 0.7531 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.571 score on a scale | Standard Deviation 0.8416 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.674 score on a scale | Standard Deviation 1.1682 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -0.950 score on a scale | Standard Deviation 1.4587 |
| Treatment Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.709 score on a scale | Standard Deviation 0.9161 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.156 score on a scale | Standard Deviation 1.0949 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.134 score on a scale | Standard Deviation 1.1573 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.687 score on a scale | Standard Deviation 0.9278 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.434 score on a scale | Standard Deviation 0.6825 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.402 score on a scale | Standard Deviation 0.5058 |
| Treatment Phase: E6011 100 mg | 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 1.2704 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.007 score on a scale | Standard Deviation 1.0644 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.642 score on a scale | Standard Deviation 0.8081 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.554 score on a scale | Standard Deviation 0.6165 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.702 score on a scale | Standard Deviation 0.6534 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.470 score on a scale | Standard Deviation 1.1853 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.819 score on a scale | Standard Deviation 0.7696 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.449 score on a scale | Standard Deviation 1.2393 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.391 score on a scale | Standard Deviation 1.0674 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.919 score on a scale | Standard Deviation 0.8813 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.237 score on a scale | Standard Deviation 1.0536 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.349 score on a scale | Standard Deviation 1.4847 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.277 score on a scale | Standard Deviation 1.4323 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.420 score on a scale | Standard Deviation 0.6906 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.833 score on a scale | Standard Deviation 1.0092 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.536 score on a scale | Standard Deviation 1.534 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -1.217 score on a scale | Standard Deviation 1.1963 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.984 score on a scale | Standard Deviation 0.8865 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.525 score on a scale | Standard Deviation 1.4998 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -1.512 score on a scale | Standard Deviation 1.3217 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -1.483 score on a scale | Standard Deviation 1.4218 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -1.367 score on a scale | Standard Deviation 1.3085 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.580 score on a scale | Standard Deviation 0.7398 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -1.438 score on a scale | Standard Deviation 1.4786 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -1.528 score on a scale | Standard Deviation 1.4876 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.387 score on a scale | Standard Deviation 1.4577 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -1.516 score on a scale | Standard Deviation 1.4242 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 84 | -1.599 score on a scale | Standard Deviation 1.5656 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.641 score on a scale | Standard Deviation 0.8217 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.839 score on a scale | Standard Deviation 1.0703 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.653 score on a scale | Standard Deviation 0.9149 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 80 | -1.580 score on a scale | Standard Deviation 1.6735 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -0.934 score on a scale | Standard Deviation 1.1527 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.242 score on a scale | Standard Deviation 1.1588 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 76 | -1.547 score on a scale | Standard Deviation 1.6002 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.215 score on a scale | Standard Deviation 1.24 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.185 score on a scale | Standard Deviation 1.3317 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -1.528 score on a scale | Standard Deviation 1.574 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.452 score on a scale | Standard Deviation 1.3306 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -1.598 score on a scale | Standard Deviation 1.4828 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.443 score on a scale | Standard Deviation 1.39 |
| Extension Phase: Placebo | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -1.409 score on a scale | Standard Deviation 1.3896 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -1.402 score on a scale | Standard Deviation 1.2321 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.653 score on a scale | Standard Deviation 0.7871 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 80 | -1.544 score on a scale | Standard Deviation 1.2228 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.423 score on a scale | Standard Deviation 0.6709 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -1.398 score on a scale | Standard Deviation 1.2493 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -1.362 score on a scale | Standard Deviation 1.3332 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.214 score on a scale | Standard Deviation 1.2817 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.364 score on a scale | Standard Deviation 1.2433 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.336 score on a scale | Standard Deviation 1.316 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -1.391 score on a scale | Standard Deviation 1.2689 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.397 score on a scale | Standard Deviation 1.389 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.392 score on a scale | Standard Deviation 0.4917 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -1.411 score on a scale | Standard Deviation 1.3355 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -1.447 score on a scale | Standard Deviation 1.327 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -1.457 score on a scale | Standard Deviation 1.2777 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -1.579 score on a scale | Standard Deviation 1.3403 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.195 score on a scale | Standard Deviation 1.1625 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 76 | -1.458 score on a scale | Standard Deviation 1.1877 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.674 score on a scale | Standard Deviation 0.9625 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.053 score on a scale | Standard Deviation 1.0693 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -1.538 score on a scale | Standard Deviation 1.2862 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.226 score on a scale | Standard Deviation 1.0921 |
| Extension Phase: E6011 100 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 84 | -1.584 score on a scale | Standard Deviation 1.3414 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.546 score on a scale | Standard Deviation 1.1363 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.775 score on a scale | Standard Deviation 0.698 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.541 score on a scale | Standard Deviation 0.6199 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.710 score on a scale | Standard Deviation 0.6435 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -0.947 score on a scale | Standard Deviation 0.8681 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.302 score on a scale | Standard Deviation 0.9895 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.445 score on a scale | Standard Deviation 1.0294 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.524 score on a scale | Standard Deviation 1.1984 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.652 score on a scale | Standard Deviation 1.2452 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -1.617 score on a scale | Standard Deviation 1.422 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.718 score on a scale | Standard Deviation 1.2962 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -1.672 score on a scale | Standard Deviation 1.1859 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -1.727 score on a scale | Standard Deviation 1.2501 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -1.734 score on a scale | Standard Deviation 1.2812 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.682 score on a scale | Standard Deviation 1.128 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -1.678 score on a scale | Standard Deviation 1.2286 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -1.764 score on a scale | Standard Deviation 1.4278 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -1.652 score on a scale | Standard Deviation 1.3363 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -1.729 score on a scale | Standard Deviation 1.4047 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -1.742 score on a scale | Standard Deviation 1.3978 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 76 | -1.833 score on a scale | Standard Deviation 1.3346 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 80 | -1.773 score on a scale | Standard Deviation 1.2908 |
| Extension Phase: E6011 200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 84 | -1.812 score on a scale | Standard Deviation 1.3174 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 36 | -1.994 score on a scale | Standard Deviation 1.533 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 84 | -2.206 score on a scale | Standard Deviation 1.5263 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 64 | -2.188 score on a scale | Standard Deviation 1.4525 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 32 | -1.856 score on a scale | Standard Deviation 1.5063 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 28 | -1.913 score on a scale | Standard Deviation 1.451 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 80 | -2.194 score on a scale | Standard Deviation 1.4738 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 68 | -2.221 score on a scale | Standard Deviation 1.4155 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 24 | -1.815 score on a scale | Standard Deviation 1.4668 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 20 | -1.787 score on a scale | Standard Deviation 1.4405 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 2 | -0.436 score on a scale | Standard Deviation 0.7121 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 72 | -2.100 score on a scale | Standard Deviation 1.493 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 16 | -1.581 score on a scale | Standard Deviation 1.4581 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 12 | -1.443 score on a scale | Standard Deviation 1.4777 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Baseline | 5.931 score on a scale | Standard Deviation 0.849 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 76 | -2.133 score on a scale | Standard Deviation 1.3671 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 52 | -1.956 score on a scale | Standard Deviation 1.4547 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 8 | -1.306 score on a scale | Standard Deviation 1.2425 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 56 | -2.122 score on a scale | Standard Deviation 1.458 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 48 | -2.004 score on a scale | Standard Deviation 1.4325 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 44 | -2.063 score on a scale | Standard Deviation 1.5432 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 4 | -0.896 score on a scale | Standard Deviation 1.0426 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 60 | -2.145 score on a scale | Standard Deviation 1.499 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Values at Each Visit Based on LOCF | Change at Week 40 | -1.947 score on a scale | Standard Deviation 1.5247 |
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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80,and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | 0.2 millimeter per hour (mm/hr) | Standard Deviation 17.72 |
| Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -1.9 millimeter per hour (mm/hr) | Standard Deviation 15.78 |
| Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 41.6 millimeter per hour (mm/hr) | Standard Deviation 26.37 |
| Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | -3.8 millimeter per hour (mm/hr) | Standard Deviation 10.4 |
| Treatment Phase: Placebo | 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 22.08 |
| Treatment Phase: Placebo | 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 23.16 |
| Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -2.3 millimeter per hour (mm/hr) | Standard Deviation 14.51 |
| Treatment Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -0.3 millimeter per hour (mm/hr) | Standard Deviation 16.46 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 1.0 millimeter per hour (mm/hr) | Standard Deviation 8.25 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -2.9 millimeter per hour (mm/hr) | Standard Deviation 15.53 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 37.9 millimeter per hour (mm/hr) | Standard Deviation 16.62 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -1.3 millimeter per hour (mm/hr) | Standard Deviation 18.75 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.3 millimeter per hour (mm/hr) | Standard Deviation 18.53 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | 0.6 millimeter per hour (mm/hr) | Standard Deviation 20.14 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 1.3 millimeter per hour (mm/hr) | Standard Deviation 11.79 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -0.3 millimeter per hour (mm/hr) | Standard Deviation 11.62 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -5.5 millimeter per hour (mm/hr) | Standard Deviation 20.68 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -6.6 millimeter per hour (mm/hr) | Standard Deviation 20.32 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -2.6 millimeter per hour (mm/hr) | Standard Deviation 7.42 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -4.0 millimeter per hour (mm/hr) | Standard Deviation 21.67 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 40.8 millimeter per hour (mm/hr) | Standard Deviation 20.06 |
| Treatment Phase: 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 18.39 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -1.8 millimeter per hour (mm/hr) | Standard Deviation 14.43 |
| Treatment Phase: 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 7.53 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -3.5 millimeter per hour (mm/hr) | Standard Deviation 17.83 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 0.7 millimeter per hour (mm/hr) | Standard Deviation 10.38 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -4.0 millimeter per hour (mm/hr) | Standard Deviation 19.17 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 40.1 millimeter per hour (mm/hr) | Standard Deviation 20.45 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -1.1 millimeter per hour (mm/hr) | Standard Deviation 13.38 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -2.9 millimeter per hour (mm/hr) | Standard Deviation 20.41 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -2.2 millimeter per hour (mm/hr) | Standard Deviation 19.92 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -3.7 millimeter per hour (mm/hr) | Standard Deviation 15.09 |
| Extension Phase: Placebo | 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 19.46 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | -4.1 millimeter per hour (mm/hr) | Standard Deviation 24.32 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | -3.2 millimeter per hour (mm/hr) | Standard Deviation 20.19 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | -4.1 millimeter per hour (mm/hr) | Standard Deviation 10.49 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | -2.0 millimeter per hour (mm/hr) | Standard Deviation 19.12 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | -4.9 millimeter per hour (mm/hr) | Standard Deviation 22 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | -0.6 millimeter per hour (mm/hr) | Standard Deviation 19.64 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | -4.6 millimeter per hour (mm/hr) | Standard Deviation 21.59 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 84 | -5.9 millimeter per hour (mm/hr) | Standard Deviation 25.74 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 14.07 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -1.5 millimeter per hour (mm/hr) | Standard Deviation 16.9 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 80 | -5.7 millimeter per hour (mm/hr) | Standard Deviation 27.22 |
| Extension Phase: Placebo | 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 15.28 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 39.6 millimeter per hour (mm/hr) | Standard Deviation 26.47 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.6 millimeter per hour (mm/hr) | Standard Deviation 14.47 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 76 | -4.2 millimeter per hour (mm/hr) | Standard Deviation 26.28 |
| Extension 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 21.23 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -1.8 millimeter per hour (mm/hr) | Standard Deviation 22.56 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | -4.5 millimeter per hour (mm/hr) | Standard Deviation 27.08 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | -4.6 millimeter per hour (mm/hr) | Standard Deviation 20.04 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 21.5 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | -4.0 millimeter per hour (mm/hr) | Standard Deviation 24.77 |
| Extension Phase: Placebo | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -4.7 millimeter per hour (mm/hr) | Standard Deviation 20.43 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 80 | -4.6 millimeter per hour (mm/hr) | Standard Deviation 19.36 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | -3.7 millimeter per hour (mm/hr) | Standard Deviation 20.94 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | 1.3 millimeter per hour (mm/hr) | Standard Deviation 12.22 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | -4.4 millimeter per hour (mm/hr) | Standard Deviation 20.37 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | -1.8 millimeter per hour (mm/hr) | Standard Deviation 21.69 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 1.7 millimeter per hour (mm/hr) | Standard Deviation 8 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | -3.2 millimeter per hour (mm/hr) | Standard Deviation 22.29 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -0.3 millimeter per hour (mm/hr) | Standard Deviation 20.57 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 84 | -5.1 millimeter per hour (mm/hr) | Standard Deviation 19.08 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | -3.5 millimeter per hour (mm/hr) | Standard Deviation 19.77 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -4.5 millimeter per hour (mm/hr) | Standard Deviation 20.44 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | -4.3 millimeter per hour (mm/hr) | Standard Deviation 19.51 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | -2.0 millimeter per hour (mm/hr) | Standard Deviation 20.91 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | -3.2 millimeter per hour (mm/hr) | Standard Deviation 22.21 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | -4.4 millimeter per hour (mm/hr) | Standard Deviation 21.73 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 37.6 millimeter per hour (mm/hr) | Standard Deviation 17.21 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | -5.0 millimeter per hour (mm/hr) | Standard Deviation 16.34 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -3.8 millimeter per hour (mm/hr) | Standard Deviation 19.14 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 76 | -4.8 millimeter per hour (mm/hr) | Standard Deviation 18.96 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 16 |
| Extension Phase: E6011 100 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 11.55 |
| Extension Phase: E6011 100 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | -2.6 millimeter per hour (mm/hr) | Standard Deviation 23.13 |
| Extension Phase: E6011 100 mg | 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 19 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | -2.1 millimeter per hour (mm/hr) | Standard Deviation 7.7 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 40.0 millimeter per hour (mm/hr) | Standard Deviation 19.67 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | -4.3 millimeter per hour (mm/hr) | Standard Deviation 24.37 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -2.8 millimeter per hour (mm/hr) | Standard Deviation 7.62 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -2.7 millimeter per hour (mm/hr) | Standard Deviation 14.19 |
| Extension Phase: 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 18.38 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 16 | -6.0 millimeter per hour (mm/hr) | Standard Deviation 21.05 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -8.0 millimeter per hour (mm/hr) | Standard Deviation 19.8 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -5.2 millimeter per hour (mm/hr) | Standard Deviation 21.47 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | -3.4 millimeter per hour (mm/hr) | Standard Deviation 23.67 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 32 | -3.9 millimeter per hour (mm/hr) | Standard Deviation 23.5 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -1.9 millimeter per hour (mm/hr) | Standard Deviation 23.56 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | -3.1 millimeter per hour (mm/hr) | Standard Deviation 24 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 44 | -3.2 millimeter per hour (mm/hr) | Standard Deviation 24.65 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | -4.2 millimeter per hour (mm/hr) | Standard Deviation 20.41 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | -2.5 millimeter per hour (mm/hr) | Standard Deviation 25.04 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | -3.9 millimeter per hour (mm/hr) | Standard Deviation 23.46 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | -3.6 millimeter per hour (mm/hr) | Standard Deviation 26.27 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | -5.5 millimeter per hour (mm/hr) | Standard Deviation 24.06 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | -5.9 millimeter per hour (mm/hr) | Standard Deviation 22.68 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 76 | -4.4 millimeter per hour (mm/hr) | Standard Deviation 22.94 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 80 | -6.1 millimeter per hour (mm/hr) | Standard Deviation 24.45 |
| Extension Phase: E6011 200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 84 | -3.0 millimeter per hour (mm/hr) | Standard Deviation 24.74 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 40 | -5.8 millimeter per hour (mm/hr) | Standard Deviation 21.58 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 36 | -4.8 millimeter per hour (mm/hr) | Standard Deviation 20.81 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 80 | -9.1 millimeter per hour (mm/hr) | Standard Deviation 18.06 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 64 | -8.0 millimeter per hour (mm/hr) | Standard Deviation 18.98 |
| Extension Phase: E6011 400/200 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 20.18 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 28 | -8.0 millimeter per hour (mm/hr) | Standard Deviation 18.76 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 2 | 0.4 millimeter per hour (mm/hr) | Standard Deviation 10.92 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 68 | -8.7 millimeter per hour (mm/hr) | Standard Deviation 17.98 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 24 | -5.4 millimeter per hour (mm/hr) | Standard Deviation 20.52 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 20 | -6.8 millimeter per hour (mm/hr) | Standard Deviation 18.86 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 72 | -7.8 millimeter per hour (mm/hr) | Standard Deviation 20.01 |
| Extension Phase: E6011 400/200 mg | 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 20.03 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 12 | -5.7 millimeter per hour (mm/hr) | Standard Deviation 17.77 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Baseline | 38.3 millimeter per hour (mm/hr) | Standard Deviation 16.91 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 76 | -7.9 millimeter per hour (mm/hr) | Standard Deviation 18.92 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 8 | -5.3 millimeter per hour (mm/hr) | Standard Deviation 15.29 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 52 | -4.9 millimeter per hour (mm/hr) | Standard Deviation 20.18 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 4 | -2.2 millimeter per hour (mm/hr) | Standard Deviation 13.49 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 56 | -6.2 millimeter per hour (mm/hr) | Standard Deviation 19.83 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 48 | -5.5 millimeter per hour (mm/hr) | Standard Deviation 19.42 |
| Extension Phase: E6011 400/200 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 22.59 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 84 | -8.1 millimeter per hour (mm/hr) | Standard Deviation 18.95 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Values at Each Visit Based on LOCF | Change at Week 60 | -7.6 millimeter per hour (mm/hr) | Standard Deviation 19.37 |
Secondary
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF
The degree of disability was self-evaluated by the participant using the HAQ-DI. The assessment was made based on the activities capable without any aids or devices. The 20-question instrument assessed the degree of difficulty a 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 a task in that area. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range: 0-3 where 0 = least difficulty and 3 = extreme difficulty. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | 0.01 units on a scale | Standard Deviation 0.493 |
| 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 0.469 |
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | 0.02 units on a scale | Standard Deviation 0.519 |
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | 0.00 units on a scale | Standard Deviation 0.281 |
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | 0.02 units on a scale | Standard Deviation 0.352 |
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | 0.00 units on a scale | Standard Deviation 0.432 |
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.02 units on a scale | Standard Deviation 0.494 |
| Treatment Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.77 units on a scale | Standard Deviation 0.526 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.10 units on a scale | Standard Deviation 0.285 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.08 units on a scale | Standard Deviation 0.33 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.73 units on a scale | Standard Deviation 0.527 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | 0.01 units on a scale | Standard Deviation 0.277 |
| Treatment Phase: E6011 100 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 0.236 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.09 units on a scale | Standard Deviation 0.3 |
| Treatment Phase: E6011 100 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 0.356 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.03 units on a scale | Standard Deviation 0.298 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.06 units on a scale | Standard Deviation 0.295 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.07 units on a scale | Standard Deviation 0.299 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.17 units on a scale | Standard Deviation 0.337 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.75 units on a scale | Standard Deviation 0.602 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.17 units on a scale | Standard Deviation 0.335 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.19 units on a scale | Standard Deviation 0.33 |
| Treatment Phase: 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 0.323 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.13 units on a scale | Standard Deviation 0.321 |
| Treatment Phase: E6011 400/200 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 0.411 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.14 units on a scale | Standard Deviation 0.402 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.06 units on a scale | Standard Deviation 0.301 |
| Treatment Phase: E6011 400/200 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 0.303 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.17 units on a scale | Standard Deviation 0.446 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.12 units on a scale | Standard Deviation 0.329 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.80 units on a scale | Standard Deviation 0.611 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.14 units on a scale | Standard Deviation 0.435 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | -0.11 units on a scale | Standard Deviation 0.544 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.09 units on a scale | Standard Deviation 0.518 |
| Extension Phase: Placebo | 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 0.544 |
| Extension Phase: Placebo | 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 0.223 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.08 units on a scale | Standard Deviation 0.546 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | -0.10 units on a scale | Standard Deviation 0.551 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.06 units on a scale | Standard Deviation 0.535 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.09 units on a scale | Standard Deviation 0.525 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 84 | -0.15 units on a scale | Standard Deviation 0.567 |
| Extension Phase: Placebo | 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 0.265 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.03 units on a scale | Standard Deviation 0.379 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.75 units on a scale | Standard Deviation 0.519 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 80 | -0.11 units on a scale | Standard Deviation 0.555 |
| Extension Phase: Placebo | 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 0.463 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.06 units on a scale | Standard Deviation 0.434 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 76 | -0.16 units on a scale | Standard Deviation 0.557 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.03 units on a scale | Standard Deviation 0.485 |
| Extension Phase: Placebo | 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 0.45 |
| Extension Phase: Placebo | 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 0.542 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | -0.07 units on a scale | Standard Deviation 0.523 |
| Extension Phase: Placebo | 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 0.559 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.05 units on a scale | Standard Deviation 0.547 |
| Extension Phase: Placebo | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.05 units on a scale | Standard Deviation 0.531 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | -0.06 units on a scale | Standard Deviation 0.357 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.03 units on a scale | Standard Deviation 0.296 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 80 | -0.12 units on a scale | Standard Deviation 0.325 |
| Extension Phase: E6011 100 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 0.281 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.06 units on a scale | Standard Deviation 0.303 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.08 units on a scale | Standard Deviation 0.337 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.08 units on a scale | Standard Deviation 0.3 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.04 units on a scale | Standard Deviation 0.318 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.06 units on a scale | Standard Deviation 0.396 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | -0.11 units on a scale | Standard Deviation 0.38 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | -0.09 units on a scale | Standard Deviation 0.278 |
| Extension Phase: E6011 100 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 0.24 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | -0.09 units on a scale | Standard Deviation 0.356 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.06 units on a scale | Standard Deviation 0.366 |
| Extension Phase: E6011 100 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 0.314 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | -0.09 units on a scale | Standard Deviation 0.297 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.06 units on a scale | Standard Deviation 0.315 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 76 | -0.11 units on a scale | Standard Deviation 0.309 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.72 units on a scale | Standard Deviation 0.541 |
| Extension Phase: E6011 100 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 0.351 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.06 units on a scale | Standard Deviation 0.366 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.09 units on a scale | Standard Deviation 0.285 |
| Extension Phase: E6011 100 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 84 | -0.08 units on a scale | Standard Deviation 0.332 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.16 units on a scale | Standard Deviation 0.339 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.74 units on a scale | Standard Deviation 0.618 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.05 units on a scale | Standard Deviation 0.297 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.06 units on a scale | Standard Deviation 0.301 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.08 units on a scale | Standard Deviation 0.319 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.11 units on a scale | Standard Deviation 0.321 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.18 units on a scale | Standard Deviation 0.332 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.17 units on a scale | Standard Deviation 0.337 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 28 | -0.21 units on a scale | Standard Deviation 0.407 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | -0.18 units on a scale | Standard Deviation 0.392 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.20 units on a scale | Standard Deviation 0.381 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.17 units on a scale | Standard Deviation 0.318 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | -0.19 units on a scale | Standard Deviation 0.415 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.20 units on a scale | Standard Deviation 0.434 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.22 units on a scale | Standard Deviation 0.385 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.20 units on a scale | Standard Deviation 0.425 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 60 | -0.19 units on a scale | Standard Deviation 0.422 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.13 units on a scale | Standard Deviation 0.457 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | -0.16 units on a scale | Standard Deviation 0.508 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | -0.19 units on a scale | Standard Deviation 0.5 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 76 | -0.18 units on a scale | Standard Deviation 0.475 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 80 | -0.16 units on a scale | Standard Deviation 0.514 |
| Extension Phase: E6011 200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 84 | -0.19 units on a scale | Standard Deviation 0.467 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 36 | -0.17 units on a scale | Standard Deviation 0.614 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 84 | -0.25 units on a scale | Standard Deviation 0.586 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 64 | -0.25 units on a scale | Standard Deviation 0.591 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 32 | -0.10 units on a scale | Standard Deviation 0.67 |
| Extension Phase: E6011 400/200 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 0.479 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 80 | -0.25 units on a scale | Standard Deviation 0.579 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 68 | -0.24 units on a scale | Standard Deviation 0.597 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 24 | -0.20 units on a scale | Standard Deviation 0.47 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 20 | -0.16 units on a scale | Standard Deviation 0.461 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 2 | -0.05 units on a scale | Standard Deviation 0.306 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 72 | -0.23 units on a scale | Standard Deviation 0.596 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 16 | -0.15 units on a scale | Standard Deviation 0.433 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 12 | -0.16 units on a scale | Standard Deviation 0.422 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Baseline | 0.71 units on a scale | Standard Deviation 0.543 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 76 | -0.26 units on a scale | Standard Deviation 0.602 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 52 | -0.19 units on a scale | Standard Deviation 0.549 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 8 | -0.13 units on a scale | Standard Deviation 0.35 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 56 | -0.20 units on a scale | Standard Deviation 0.539 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 48 | -0.20 units on a scale | Standard Deviation 0.592 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 44 | -0.19 units on a scale | Standard Deviation 0.561 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 4 | -0.12 units on a scale | Standard Deviation 0.304 |
| Extension Phase: E6011 400/200 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 0.567 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Each Visit Based on LOCF | Change at Week 40 | -0.19 units on a scale | Standard Deviation 0.594 |
Secondary
Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC)
The mTSS was a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \[normal\] to 528 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of \<=0.5. Data reported for the Extension Phase from Baseline and Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: Treatment Phase: Baseline and Week 24; Extension Phase: Baseline, Weeks 24, 52, 76, and 104
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using OC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 27.20 units on a scale | Standard Deviation 46.948 |
| Treatment Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 1.31 units on a scale | Standard Deviation 2.639 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 30.00 units on a scale | Standard Deviation 36.582 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 2.54 units on a scale | Standard Deviation 4.768 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 37.55 units on a scale | Standard Deviation 56.095 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 1.82 units on a scale | Standard Deviation 4.075 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 1.34 units on a scale | Standard Deviation 3.106 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 27.64 units on a scale | Standard Deviation 40.621 |
| Extension Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 17.08 units on a scale | Standard Deviation 25.897 |
| Extension Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 76 | 3.00 units on a scale | Standard Deviation 5.931 |
| Extension Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 1.01 units on a scale | Standard Deviation 1.929 |
| Extension Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 104 | 3.49 units on a scale | Standard Deviation 6.643 |
| Extension Phase: Placebo | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 52 | 2.37 units on a scale | Standard Deviation 4.302 |
| Extension Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 29.11 units on a scale | Standard Deviation 34.551 |
| Extension Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 1.20 units on a scale | Standard Deviation 3.092 |
| Extension Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 52 | 3.11 units on a scale | Standard Deviation 4.711 |
| Extension Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 76 | 3.61 units on a scale | Standard Deviation 5.631 |
| Extension Phase: E6011 100 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 104 | 4.02 units on a scale | Standard Deviation 5.598 |
| Extension Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 0.95 units on a scale | Standard Deviation 3.392 |
| Extension Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 31.61 units on a scale | Standard Deviation 47.092 |
| Extension Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 52 | 3.35 units on a scale | Standard Deviation 10.366 |
| Extension Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 76 | 3.96 units on a scale | Standard Deviation 14.378 |
| Extension Phase: E6011 200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 104 | 4.70 units on a scale | Standard Deviation 17.549 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 76 | 1.63 units on a scale | Standard Deviation 3.992 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 24 | 0.49 units on a scale | Standard Deviation 1.438 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Baseline | 26.19 units on a scale | Standard Deviation 35.524 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 52 | 1.33 units on a scale | Standard Deviation 3.559 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Each Visit Based on Observed Cases (OC) | Change at Week 104 | 1.57 units on a scale | Standard Deviation 3.885 |
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. 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 | -7.5 units on a scale | Standard Deviation 26.09 |
| 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 | -10.8 units on a scale | Standard Deviation 27.25 |
| 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 | -9.1 units on a scale | Standard Deviation 29.43 |
| 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 | -4.0 units on a scale | Standard Deviation 17.96 |
| 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 | -5.8 units on a scale | Standard Deviation 22.47 |
| 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 | -7.8 units on a scale | Standard Deviation 20.76 |
| 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 | -9.4 units on a scale | Standard Deviation 28.49 |
| Treatment Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 53.6 units on a scale | Standard Deviation 23.03 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -13.5 units on a scale | Standard Deviation 19.33 |
| Treatment Phase: E6011 100 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 units on a scale | Standard Deviation 19.69 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 47.9 units on a scale | Standard Deviation 26.37 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -6.4 units on a scale | Standard Deviation 20.68 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.5 units on a scale | Standard Deviation 12.64 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -13.9 units on a scale | Standard Deviation 21.59 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -12.2 units on a scale | Standard Deviation 18.19 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -4.9 units on a scale | Standard Deviation 19.96 |
| Treatment Phase: 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 | -6.2 units on a scale | Standard Deviation 17.22 |
| Treatment Phase: 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 | -4.1 units on a scale | Standard Deviation 18.36 |
| Treatment Phase: 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 | -14.4 units on a scale | Standard Deviation 20.85 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 46.6 units on a scale | Standard Deviation 23.03 |
| Treatment Phase: 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 units on a scale | Standard Deviation 21.08 |
| Treatment Phase: 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 | -13.6 units on a scale | Standard Deviation 20.87 |
| Treatment Phase: 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 | -10.0 units on a scale | Standard Deviation 18.29 |
| Treatment Phase: 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 | -12.9 units on a scale | Standard Deviation 21.24 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -15.1 units on a scale | Standard Deviation 25.78 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -13.7 units on a scale | Standard Deviation 25.24 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -5.9 units on a scale | Standard Deviation 16.91 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -9.0 units on a scale | Standard Deviation 18.93 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -18.5 units on a scale | Standard Deviation 24.29 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -16.6 units on a scale | Standard Deviation 22.58 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 52.9 units on a scale | Standard Deviation 24.38 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -16.6 units on a scale | Standard Deviation 26.04 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -17.9 units on a scale | Standard Deviation 27.27 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -21.2 units on a scale | Standard Deviation 26.46 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -16.7 units on a scale | Standard Deviation 26.93 |
| Extension 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 | -5.2 units on a scale | Standard Deviation 18.88 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -20.0 units on a scale | Standard Deviation 27.74 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -22.6 units on a scale | Standard Deviation 28.21 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -17.2 units on a scale | Standard Deviation 28.24 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -20.8 units on a scale | Standard Deviation 27.88 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 84 | -23.2 units on a scale | Standard Deviation 28.58 |
| Extension 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 | -9.0 units on a scale | Standard Deviation 21.34 |
| Extension 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 | -10.5 units on a scale | Standard Deviation 18.73 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 54.2 units on a scale | Standard Deviation 21.89 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 80 | -21.4 units on a scale | Standard Deviation 29.2 |
| Extension 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 | -11.0 units on a scale | Standard Deviation 25.1 |
| Extension 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 | -14.1 units on a scale | Standard Deviation 26.26 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 76 | -21.4 units on a scale | Standard Deviation 27.7 |
| Extension 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 | -12.9 units on a scale | Standard Deviation 28.35 |
| Extension 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 | -13.2 units on a scale | Standard Deviation 27.17 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -23.3 units on a scale | Standard Deviation 27.81 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -18.0 units on a scale | Standard Deviation 26.34 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -24.6 units on a scale | Standard Deviation 27.59 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -15.5 units on a scale | Standard Deviation 28.89 |
| Extension Phase: Placebo | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -15.3 units on a scale | Standard Deviation 28.08 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -16.7 units on a scale | Standard Deviation 24.96 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -5.7 units on a scale | Standard Deviation 20.51 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 80 | -19.3 units on a scale | Standard Deviation 25.29 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -6.6 units on a scale | Standard Deviation 21.47 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -16.0 units on a scale | Standard Deviation 25.02 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -15.5 units on a scale | Standard Deviation 23.14 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 24 | -14.8 units on a scale | Standard Deviation 22.11 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -15.3 units on a scale | Standard Deviation 25.63 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -14.4 units on a scale | Standard Deviation 23.58 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -17.8 units on a scale | Standard Deviation 21.77 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -12.9 units on a scale | Standard Deviation 25.13 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -4.4 units on a scale | Standard Deviation 13.08 |
| Extension Phase: E6011 100 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 units on a scale | Standard Deviation 25.96 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -17.6 units on a scale | Standard Deviation 24.36 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -16.9 units on a scale | Standard Deviation 23.06 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -16.2 units on a scale | Standard Deviation 23.69 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 16 | -11.7 units on a scale | Standard Deviation 20.42 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 76 | -19.0 units on a scale | Standard Deviation 26.29 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 46.6 units on a scale | Standard Deviation 26.94 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -12.8 units on a scale | Standard Deviation 18.75 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -16.1 units on a scale | Standard Deviation 24.34 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -14.4 units on a scale | Standard Deviation 19.75 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 84 | -18.3 units on a scale | Standard Deviation 26.01 |
| Extension Phase: 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 | -16.0 units on a scale | Standard Deviation 20.47 |
| Extension Phase: E6011 200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 46.7 units on a scale | Standard Deviation 22.95 |
| Extension Phase: 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 | -6.4 units on a scale | Standard Deviation 17.81 |
| Extension Phase: 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 | -4.4 units on a scale | Standard Deviation 18.77 |
| Extension Phase: 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 | -11.0 units on a scale | Standard Deviation 18.45 |
| Extension Phase: 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 | -14.6 units on a scale | Standard Deviation 20.72 |
| Extension Phase: 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 | -14.8 units on a scale | Standard Deviation 20.91 |
| Extension Phase: 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 | -16.6 units on a scale | Standard Deviation 20.67 |
| Extension Phase: 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 | -14.0 units on a scale | Standard Deviation 22.45 |
| Extension Phase: 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 | -14.6 units on a scale | Standard Deviation 22.57 |
| Extension Phase: 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 | -16.8 units on a scale | Standard Deviation 25.04 |
| Extension Phase: 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 | -17.7 units on a scale | Standard Deviation 23.93 |
| Extension Phase: 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 | -17.5 units on a scale | Standard Deviation 23.27 |
| Extension Phase: 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 | -17.6 units on a scale | Standard Deviation 22.5 |
| Extension Phase: 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 | -16.9 units on a scale | Standard Deviation 25.39 |
| Extension Phase: 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 | -18.7 units on a scale | Standard Deviation 22.74 |
| Extension Phase: 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 | -18.0 units on a scale | Standard Deviation 23.76 |
| Extension Phase: 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 | -17.5 units on a scale | Standard Deviation 26.63 |
| Extension Phase: 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 | -16.2 units on a scale | Standard Deviation 25.65 |
| Extension Phase: 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 | -16.2 units on a scale | Standard Deviation 25.49 |
| Extension Phase: 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 76 | -16.9 units on a scale | Standard Deviation 25.92 |
| Extension Phase: 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 80 | -16.2 units on a scale | Standard Deviation 25.09 |
| Extension Phase: 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 84 | -17.1 units on a scale | Standard Deviation 24.5 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 36 | -22.2 units on a scale | Standard Deviation 31.15 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 84 | -24.4 units on a scale | Standard Deviation 27.29 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 64 | -22.0 units on a scale | Standard Deviation 26.8 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 32 | -21.0 units on a scale | Standard Deviation 33.28 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 28 | -22.3 units on a scale | Standard Deviation 27.16 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 80 | -24.8 units on a scale | Standard Deviation 25.53 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 68 | -24.1 units on a scale | Standard Deviation 27.79 |
| Extension Phase: E6011 400/200 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 units on a scale | Standard Deviation 24.35 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 20 | -19.3 units on a scale | Standard Deviation 26.67 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 2 | -5.1 units on a scale | Standard Deviation 17 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 72 | -24.5 units on a scale | Standard Deviation 27.82 |
| Extension Phase: E6011 400/200 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 units on a scale | Standard Deviation 26.62 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 12 | -15.2 units on a scale | Standard Deviation 26.57 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Baseline | 49.6 units on a scale | Standard Deviation 24.25 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 76 | -24.2 units on a scale | Standard Deviation 28 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 52 | -22.7 units on a scale | Standard Deviation 24.17 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 8 | -17.0 units on a scale | Standard Deviation 23.5 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 56 | -21.8 units on a scale | Standard Deviation 24.98 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 48 | -23.4 units on a scale | Standard Deviation 28.36 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 44 | -23.1 units on a scale | Standard Deviation 29.58 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 4 | -8.3 units on a scale | Standard Deviation 19.19 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 60 | -24.6 units on a scale | Standard Deviation 26.9 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Assessment of Pain Based on VAS Score at Each Visit Based on LOCF | Change at Week 40 | -22.7 units on a scale | Standard Deviation 29.17 |
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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 | -10.0 units on a scale | Standard Deviation 30.67 |
| 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 | -11.6 units on a scale | Standard Deviation 27.4 |
| 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 | -6.4 units on a scale | Standard Deviation 24.49 |
| 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 | 53.1 units on a scale | Standard Deviation 25.74 |
| 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 | -5.5 units on a scale | Standard Deviation 23.48 |
| 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 | -8.8 units on a scale | Standard Deviation 30.97 |
| 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 | -2.9 units on a scale | Standard Deviation 20.03 |
| 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 | -7.3 units on a scale | Standard Deviation 27.83 |
| Treatment Phase: E6011 100 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 units on a scale | Standard Deviation 14.32 |
| Treatment Phase: E6011 100 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 | -6.6 units on a scale | Standard Deviation 17.03 |
| Treatment Phase: E6011 100 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 | -14.6 units on a scale | Standard Deviation 18.22 |
| Treatment Phase: E6011 100 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 | -14.0 units on a scale | Standard Deviation 20.19 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 50.1 units on a scale | Standard Deviation 25.04 |
| Treatment Phase: E6011 100 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 | -15.3 units on a scale | Standard Deviation 23.29 |
| Treatment Phase: E6011 100 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 | -7.3 units on a scale | Standard Deviation 18.62 |
| Treatment Phase: E6011 100 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 | -15.3 units on a scale | Standard Deviation 19.24 |
| Treatment Phase: 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 units on a scale | Standard Deviation 18.67 |
| Treatment Phase: 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 | -15.2 units on a scale | Standard Deviation 18.5 |
| Treatment Phase: 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 | -8.3 units on a scale | Standard Deviation 17.32 |
| Treatment Phase: 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 | -17.8 units on a scale | Standard Deviation 20.27 |
| Treatment Phase: 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 | 49.0 units on a scale | Standard Deviation 22.37 |
| Treatment Phase: 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 | -7.2 units on a scale | Standard Deviation 16.29 |
| Treatment Phase: 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 | -17.4 units on a scale | Standard Deviation 21.43 |
| Treatment Phase: 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 | -16.1 units on a scale | Standard Deviation 20.49 |
| Treatment Phase: E6011 400/200 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 | -16.6 units on a scale | Standard Deviation 27.22 |
| Treatment Phase: E6011 400/200 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 | -20.4 units on a scale | Standard Deviation 24.9 |
| Treatment Phase: E6011 400/200 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 | -6.4 units on a scale | Standard Deviation 16.4 |
| Treatment Phase: E6011 400/200 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 | -9.8 units on a scale | Standard Deviation 19.73 |
| Treatment Phase: E6011 400/200 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 | -18.1 units on a scale | Standard Deviation 23.66 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 54.5 units on a scale | Standard Deviation 23.97 |
| Treatment Phase: E6011 400/200 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 | -15.1 units on a scale | Standard Deviation 27.23 |
| Treatment Phase: E6011 400/200 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 | -17.8 units on a scale | Standard Deviation 28.14 |
| Extension 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 80 | -21.0 units on a scale | Standard Deviation 30.98 |
| Extension 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 48 | -18.5 units on a scale | Standard Deviation 28.84 |
| Extension 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 68 | -22.9 units on a scale | Standard Deviation 28.89 |
| Extension 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 52 | -16.1 units on a scale | Standard Deviation 31.2 |
| Extension 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 56 | -20.0 units on a scale | Standard Deviation 29.52 |
| Extension 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 64 | -20.1 units on a scale | Standard Deviation 27.01 |
| Extension 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 60 | -21.3 units on a scale | Standard Deviation 28.76 |
| Extension 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 | -9.4 units on a scale | Standard Deviation 23.96 |
| Extension 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 | -7.5 units on a scale | Standard Deviation 22.61 |
| Extension Phase: Placebo | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 53.4 units on a scale | Standard Deviation 25.3 |
| Extension 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 | -10.0 units on a scale | Standard Deviation 27.59 |
| Extension 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 | -14.7 units on a scale | Standard Deviation 26.47 |
| Extension 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 84 | -21.1 units on a scale | Standard Deviation 31.62 |
| Extension 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 | -13.6 units on a scale | Standard Deviation 29.69 |
| Extension 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 | -12.3 units on a scale | Standard Deviation 30.2 |
| Extension 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 | -3.8 units on a scale | Standard Deviation 21.28 |
| Extension 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 28 | -17.1 units on a scale | Standard Deviation 30.18 |
| Extension 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 32 | -19.3 units on a scale | Standard Deviation 29.27 |
| Extension 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 76 | -21.3 units on a scale | Standard Deviation 29.79 |
| Extension 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 36 | -15.7 units on a scale | Standard Deviation 28.4 |
| Extension 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 40 | -15.8 units on a scale | Standard Deviation 30.76 |
| Extension 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 72 | -21.7 units on a scale | Standard Deviation 31.19 |
| Extension 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 44 | -16.9 units on a scale | Standard Deviation 27.2 |
| Extension Phase: E6011 100 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 | -18.0 units on a scale | Standard Deviation 23.09 |
| Extension Phase: E6011 100 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 | -17.0 units on a scale | Standard Deviation 22.63 |
| Extension Phase: E6011 100 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 | -17.0 units on a scale | Standard Deviation 23.3 |
| Extension Phase: E6011 100 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 | -19.1 units on a scale | Standard Deviation 23.63 |
| Extension Phase: E6011 100 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 | -19.6 units on a scale | Standard Deviation 22.9 |
| Extension Phase: E6011 100 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 | -19.0 units on a scale | Standard Deviation 24.98 |
| Extension Phase: E6011 100 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 | -17.0 units on a scale | Standard Deviation 24.5 |
| Extension Phase: E6011 100 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 | -17.0 units on a scale | Standard Deviation 23.15 |
| Extension Phase: E6011 100 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 76 | -20.9 units on a scale | Standard Deviation 24.88 |
| Extension Phase: E6011 100 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 | -20.3 units on a scale | Standard Deviation 20.23 |
| Extension Phase: E6011 100 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 | -19.8 units on a scale | Standard Deviation 20.81 |
| Extension Phase: E6011 100 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 84 | -19.6 units on a scale | Standard Deviation 24.67 |
| Extension Phase: E6011 100 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 | -4.5 units on a scale | Standard Deviation 14.7 |
| Extension Phase: E6011 100 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 | -15.3 units on a scale | Standard Deviation 20.31 |
| Extension Phase: E6011 100 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 49.2 units on a scale | Standard Deviation 25.77 |
| Extension Phase: E6011 100 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 | -18.6 units on a scale | Standard Deviation 21.01 |
| Extension Phase: E6011 100 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 | -19.5 units on a scale | Standard Deviation 25.09 |
| Extension Phase: E6011 100 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 | -17.0 units on a scale | Standard Deviation 18.89 |
| Extension Phase: E6011 100 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 | -15.8 units on a scale | Standard Deviation 18.36 |
| Extension Phase: E6011 100 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 80 | -20.4 units on a scale | Standard Deviation 24.23 |
| Extension Phase: E6011 100 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 | -8.5 units on a scale | Standard Deviation 18.82 |
| Extension Phase: E6011 100 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 units on a scale | Standard Deviation 17.5 |
| Extension Phase: E6011 100 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 | -19.0 units on a scale | Standard Deviation 21.14 |
| Extension Phase: 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 | -18.5 units on a scale | Standard Deviation 21.28 |
| Extension Phase: 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 | 49.2 units on a scale | Standard Deviation 22.19 |
| Extension Phase: 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 | -8.5 units on a scale | Standard Deviation 17.84 |
| Extension Phase: 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 | -7.6 units on a scale | Standard Deviation 16.64 |
| Extension Phase: 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 | -12.8 units on a scale | Standard Deviation 18.8 |
| Extension Phase: 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 | -17.0 units on a scale | Standard Deviation 17.62 |
| Extension Phase: 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 | -17.4 units on a scale | Standard Deviation 20.46 |
| Extension Phase: 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 | -19.2 units on a scale | Standard Deviation 21.03 |
| Extension Phase: 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 | -19.6 units on a scale | Standard Deviation 19.72 |
| Extension Phase: 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 | -16.7 units on a scale | Standard Deviation 24.64 |
| Extension Phase: 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 | -19.6 units on a scale | Standard Deviation 24.05 |
| Extension Phase: 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 | -20.4 units on a scale | Standard Deviation 23.4 |
| Extension Phase: 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 | -20.2 units on a scale | Standard Deviation 23.05 |
| Extension Phase: 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 | -20.3 units on a scale | Standard Deviation 20.8 |
| Extension Phase: 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 | -19.4 units on a scale | Standard Deviation 23.97 |
| Extension Phase: 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 | -20.3 units on a scale | Standard Deviation 21.95 |
| Extension Phase: 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 | -20.8 units on a scale | Standard Deviation 23.05 |
| Extension Phase: 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 | -19.9 units on a scale | Standard Deviation 24.04 |
| Extension Phase: 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 | -18.6 units on a scale | Standard Deviation 24.69 |
| Extension Phase: 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 | -18.6 units on a scale | Standard Deviation 25.14 |
| Extension Phase: 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 76 | -20.3 units on a scale | Standard Deviation 25.11 |
| Extension Phase: 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 80 | -19.2 units on a scale | Standard Deviation 23.56 |
| Extension Phase: 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 84 | -19.6 units on a scale | Standard Deviation 22.45 |
| Extension Phase: E6011 400/200 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 | -25.0 units on a scale | Standard Deviation 29.55 |
| Extension Phase: E6011 400/200 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 84 | -27.0 units on a scale | Standard Deviation 28.96 |
| Extension Phase: E6011 400/200 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 | -26.9 units on a scale | Standard Deviation 28.56 |
| Extension Phase: E6011 400/200 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 | -24.6 units on a scale | Standard Deviation 29.17 |
| Extension Phase: E6011 400/200 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 | -24.2 units on a scale | Standard Deviation 31.25 |
| Extension Phase: E6011 400/200 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 | -18.8 units on a scale | Standard Deviation 24.76 |
| Extension Phase: E6011 400/200 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 | -26.4 units on a scale | Standard Deviation 28.61 |
| Extension Phase: E6011 400/200 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 | -23.2 units on a scale | Standard Deviation 32.64 |
| Extension Phase: E6011 400/200 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 | -24.8 units on a scale | Standard Deviation 27.56 |
| Extension Phase: E6011 400/200 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 | -9.5 units on a scale | Standard Deviation 20.26 |
| Extension Phase: E6011 400/200 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 76 | -26.2 units on a scale | Standard Deviation 28.19 |
| Extension Phase: E6011 400/200 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 | -23.8 units on a scale | Standard Deviation 25.11 |
| Extension Phase: E6011 400/200 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 | -20.7 units on a scale | Standard Deviation 29.3 |
| Extension Phase: E6011 400/200 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 | -5.5 units on a scale | Standard Deviation 16.45 |
| Extension Phase: E6011 400/200 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 80 | -27.3 units on a scale | Standard Deviation 27.01 |
| Extension Phase: E6011 400/200 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 | -19.3 units on a scale | Standard Deviation 28.4 |
| Extension Phase: E6011 400/200 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 | -17.3 units on a scale | Standard Deviation 28.74 |
| Extension Phase: E6011 400/200 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 | -26.3 units on a scale | Standard Deviation 27.92 |
| Extension Phase: E6011 400/200 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 | -25.2 units on a scale | Standard Deviation 27.24 |
| Extension Phase: E6011 400/200 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 | -24.6 units on a scale | Standard Deviation 25.27 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Participant's Global Assessment of Disease Activity Based on VAS Score at Each Visit Based on LOCF | Baseline | 51.3 units on a scale | Standard Deviation 23.89 |
| Extension Phase: E6011 400/200 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 | -24.5 units on a scale | Standard Deviation 27.89 |
| Extension Phase: E6011 400/200 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 | -24.8 units on a scale | Standard Deviation 29.19 |
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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 | 54.3 units on a scale | Standard Deviation 19.07 |
| 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 | -16.1 units on a scale | Standard Deviation 23.49 |
| 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 | -14.9 units on a scale | Standard Deviation 24.14 |
| 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 | -10.1 units on a scale | Standard Deviation 15.95 |
| 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 | -8.4 units on a scale | Standard Deviation 16.83 |
| 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 | -13.6 units on a scale | Standard Deviation 21.08 |
| 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 | -15.3 units on a scale | Standard Deviation 25.97 |
| 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 | -15.5 units on a scale | Standard Deviation 26.23 |
| Treatment Phase: E6011 100 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 | -20.0 units on a scale | Standard Deviation 21.27 |
| Treatment Phase: E6011 100 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 | -19.3 units on a scale | Standard Deviation 20.88 |
| Treatment Phase: E6011 100 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 | -7.6 units on a scale | Standard Deviation 14.11 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 53.1 units on a scale | Standard Deviation 21.88 |
| Treatment Phase: E6011 100 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 | -17.8 units on a scale | Standard Deviation 24.33 |
| Treatment Phase: E6011 100 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 | -11.3 units on a scale | Standard Deviation 16.87 |
| Treatment Phase: E6011 100 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 | -9.5 units on a scale | Standard Deviation 16.32 |
| Treatment Phase: E6011 100 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 | -16.9 units on a scale | Standard Deviation 24.74 |
| Treatment Phase: 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 | -16.6 units on a scale | Standard Deviation 20.75 |
| Treatment Phase: 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 units on a scale | Standard Deviation 20.21 |
| Treatment Phase: 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 | 55.2 units on a scale | Standard Deviation 17.27 |
| Treatment Phase: 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 | -21.6 units on a scale | Standard Deviation 18.54 |
| Treatment Phase: 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 | -22.7 units on a scale | Standard Deviation 20.32 |
| Treatment Phase: 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 | -11.1 units on a scale | Standard Deviation 15.59 |
| Treatment Phase: 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 | -24.6 units on a scale | Standard Deviation 21.38 |
| Treatment Phase: 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 | -15.2 units on a scale | Standard Deviation 16.36 |
| Treatment Phase: E6011 400/200 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 | -13.2 units on a scale | Standard Deviation 20.76 |
| Treatment Phase: E6011 400/200 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 | -7.9 units on a scale | Standard Deviation 16.61 |
| Treatment Phase: E6011 400/200 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 | -20.8 units on a scale | Standard Deviation 27.39 |
| Treatment Phase: E6011 400/200 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 | -16.1 units on a scale | Standard Deviation 21.51 |
| Treatment Phase: E6011 400/200 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 | -18.9 units on a scale | Standard Deviation 28.39 |
| Treatment Phase: E6011 400/200 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 | -18.1 units on a scale | Standard Deviation 26.27 |
| Treatment Phase: E6011 400/200 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 | -19.3 units on a scale | Standard Deviation 25.83 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 54.2 units on a scale | Standard Deviation 22.02 |
| Extension 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 80 | -24.0 units on a scale | Standard Deviation 28.33 |
| Extension 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 52 | -23.3 units on a scale | Standard Deviation 28.22 |
| Extension 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 48 | -27.3 units on a scale | Standard Deviation 29.35 |
| Extension 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 32 | -25.9 units on a scale | Standard Deviation 25.28 |
| Extension 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 44 | -25.8 units on a scale | Standard Deviation 28.22 |
| Extension 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 40 | -25.2 units on a scale | Standard Deviation 26.39 |
| Extension 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 36 | -23.9 units on a scale | Standard Deviation 25.96 |
| Extension 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 | -9.9 units on a scale | Standard Deviation 15.99 |
| Extension 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 | -17.1 units on a scale | Standard Deviation 21.36 |
| Extension 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 | -10.4 units on a scale | Standard Deviation 14.73 |
| Extension 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 | -15.5 units on a scale | Standard Deviation 17.7 |
| Extension 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 84 | -25.9 units on a scale | Standard Deviation 28.47 |
| Extension 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 28 | -24.4 units on a scale | Standard Deviation 22.28 |
| Extension 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 | -19.1 units on a scale | Standard Deviation 21.49 |
| Extension 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 | 53.7 units on a scale | Standard Deviation 19.17 |
| Extension 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 76 | -23.5 units on a scale | Standard Deviation 28.17 |
| Extension 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 72 | -25.0 units on a scale | Standard Deviation 28.1 |
| Extension 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 | -18.8 units on a scale | Standard Deviation 24.2 |
| Extension 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 68 | -27.9 units on a scale | Standard Deviation 27.73 |
| Extension 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 64 | -26.4 units on a scale | Standard Deviation 28.15 |
| Extension 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 | -19.0 units on a scale | Standard Deviation 24.49 |
| Extension 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 60 | -23.9 units on a scale | Standard Deviation 28.72 |
| Extension 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 56 | -23.6 units on a scale | Standard Deviation 25.87 |
| Extension Phase: E6011 100 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 80 | -24.9 units on a scale | Standard Deviation 26.05 |
| Extension Phase: E6011 100 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 | -6.7 units on a scale | Standard Deviation 13.23 |
| Extension Phase: E6011 100 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 52.0 units on a scale | Standard Deviation 22.2 |
| Extension Phase: E6011 100 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 | -7.3 units on a scale | Standard Deviation 14.59 |
| Extension Phase: E6011 100 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 | -19.3 units on a scale | Standard Deviation 20.91 |
| Extension Phase: E6011 100 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 | -20.9 units on a scale | Standard Deviation 21.65 |
| Extension Phase: E6011 100 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 | -18.4 units on a scale | Standard Deviation 24.96 |
| Extension Phase: E6011 100 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 | -20.1 units on a scale | Standard Deviation 24.68 |
| Extension Phase: E6011 100 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 | -21.7 units on a scale | Standard Deviation 26.24 |
| Extension Phase: E6011 100 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 | -19.3 units on a scale | Standard Deviation 23.02 |
| Extension Phase: E6011 100 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 units on a scale | Standard Deviation 25.52 |
| Extension Phase: E6011 100 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 | -19.8 units on a scale | Standard Deviation 22.76 |
| Extension Phase: E6011 100 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 | -21.6 units on a scale | Standard Deviation 25.58 |
| Extension Phase: E6011 100 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 | -19.9 units on a scale | Standard Deviation 24.81 |
| Extension Phase: E6011 100 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 | -20.8 units on a scale | Standard Deviation 24.91 |
| Extension Phase: E6011 100 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 | -21.1 units on a scale | Standard Deviation 23.93 |
| Extension Phase: E6011 100 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 | -20.1 units on a scale | Standard Deviation 22.32 |
| Extension Phase: E6011 100 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 | -21.6 units on a scale | Standard Deviation 26.92 |
| Extension Phase: E6011 100 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 | -20.2 units on a scale | Standard Deviation 22.55 |
| Extension Phase: E6011 100 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 76 | -22.4 units on a scale | Standard Deviation 22.89 |
| Extension Phase: E6011 100 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 84 | -21.8 units on a scale | Standard Deviation 24.09 |
| Extension Phase: E6011 100 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 | -9.3 units on a scale | Standard Deviation 15.25 |
| Extension Phase: E6011 100 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 | -16.8 units on a scale | Standard Deviation 25.04 |
| Extension Phase: 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 | -27.8 units on a scale | Standard Deviation 20.44 |
| Extension Phase: 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 | -28.1 units on a scale | Standard Deviation 19.69 |
| Extension Phase: 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 | -26.7 units on a scale | Standard Deviation 20.55 |
| Extension Phase: 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 | -10.3 units on a scale | Standard Deviation 15.78 |
| Extension Phase: 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 | -26.8 units on a scale | Standard Deviation 19.72 |
| Extension Phase: 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 | -25.4 units on a scale | Standard Deviation 20.91 |
| Extension Phase: 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 | -27.0 units on a scale | Standard Deviation 21.24 |
| Extension Phase: 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 | -24.9 units on a scale | Standard Deviation 21.16 |
| Extension Phase: 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 | -23.3 units on a scale | Standard Deviation 19.81 |
| Extension Phase: 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 | 54.2 units on a scale | Standard Deviation 17.3 |
| Extension Phase: 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 | -27.4 units on a scale | Standard Deviation 21.1 |
| Extension Phase: 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 | -27.1 units on a scale | Standard Deviation 22.45 |
| Extension Phase: 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 units on a scale | Standard Deviation 20 |
| Extension Phase: 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 | -15.0 units on a scale | Standard Deviation 16.68 |
| Extension Phase: 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 76 | -27.6 units on a scale | Standard Deviation 21.89 |
| Extension Phase: 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 | -16.7 units on a scale | Standard Deviation 21 |
| Extension Phase: 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 80 | -26.9 units on a scale | Standard Deviation 21.29 |
| Extension Phase: 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 | -25.3 units on a scale | Standard Deviation 20.46 |
| Extension Phase: 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 | -27.8 units on a scale | Standard Deviation 16.77 |
| Extension Phase: 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 | -24.4 units on a scale | Standard Deviation 21.13 |
| Extension Phase: 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 | -22.3 units on a scale | Standard Deviation 17.53 |
| Extension Phase: 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 | -27.6 units on a scale | Standard Deviation 19.34 |
| Extension Phase: 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 84 | -27.3 units on a scale | Standard Deviation 20.49 |
| Extension Phase: E6011 400/200 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 | -29.2 units on a scale | Standard Deviation 27.19 |
| Extension Phase: E6011 400/200 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 | -29.0 units on a scale | Standard Deviation 25.74 |
| Extension Phase: E6011 400/200 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 84 | -30.1 units on a scale | Standard Deviation 25.7 |
| Extension Phase: E6011 400/200 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 | -25.9 units on a scale | Standard Deviation 26.01 |
| Extension Phase: E6011 400/200 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 | -26.8 units on a scale | Standard Deviation 28.3 |
| Extension Phase: E6011 400/200 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 | -25.7 units on a scale | Standard Deviation 25.19 |
| Extension Phase: E6011 400/200 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 | -8.1 units on a scale | Standard Deviation 17.63 |
| Extension Phase: E6011 400/200 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 units on a scale | Standard Deviation 29.34 |
| Extension Phase: E6011 400/200 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 | -28.2 units on a scale | Standard Deviation 26.27 |
| Extension Phase: E6011 400/200 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 76 | -31.2 units on a scale | Standard Deviation 26.22 |
| Extension Phase: E6011 400/200 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 | -19.5 units on a scale | Standard Deviation 26.63 |
| Extension Phase: E6011 400/200 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 | -19.0 units on a scale | Standard Deviation 21.63 |
| Extension Phase: E6011 400/200 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 | -29.7 units on a scale | Standard Deviation 26.7 |
| Extension Phase: E6011 400/200 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 | -23.1 units on a scale | Standard Deviation 27.08 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Physician's Global Assessment of Disease Activity Scale Based on VAS Score at Each Visit Based on LOCF | Baseline | 53.9 units on a scale | Standard Deviation 21.28 |
| Extension Phase: E6011 400/200 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 | -27.0 units on a scale | Standard Deviation 27.64 |
| Extension Phase: E6011 400/200 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 | -29.4 units on a scale | Standard Deviation 25.93 |
| Extension Phase: E6011 400/200 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 | -29.2 units on a scale | Standard Deviation 28.51 |
| Extension Phase: E6011 400/200 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 80 | -31.5 units on a scale | Standard Deviation 25.95 |
| Extension Phase: E6011 400/200 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 | -27.4 units on a scale | Standard Deviation 26.36 |
| Extension Phase: E6011 400/200 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 | -30.3 units on a scale | Standard Deviation 27.03 |
| Extension Phase: E6011 400/200 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 | -23.7 units on a scale | Standard Deviation 23.8 |
| Extension Phase: E6011 400/200 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 | -13.8 units on a scale | Standard Deviation 21.74 |
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, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-86. SDAI score of 26 or above = high disease activity, a value between 11 and 26 = moderate disease activity and value less than or equal to (\<=) 11 = low disease activity, value \<=33 = disease remission. Higher scores indicated higher disease activity. Data reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 30.694 score on a scale | Standard Deviation 10.7598 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -5.722 score on a scale | Standard Deviation 8.8627 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -8.691 score on a scale | Standard Deviation 14.3072 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -8.996 score on a scale | Standard Deviation 14.778 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -9.294 score on a scale | Standard Deviation 13.2176 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -7.546 score on a scale | Standard Deviation 13.0215 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.093 score on a scale | Standard Deviation 8.0941 |
| Treatment Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -7.241 score on a scale | Standard Deviation 12.4374 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -10.132 score on a scale | Standard Deviation 10.8337 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -4.889 score on a scale | Standard Deviation 7.3568 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 30.546 score on a scale | Standard Deviation 12.5152 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -7.636 score on a scale | Standard Deviation 9.0091 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -12.446 score on a scale | Standard Deviation 11.0107 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.618 score on a scale | Standard Deviation 6.0585 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -12.043 score on a scale | Standard Deviation 10.7104 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -12.671 score on a scale | Standard Deviation 11.6001 |
| Treatment Phase: 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 9.8357 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -14.743 score on a scale | Standard Deviation 11.6082 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.704 score on a scale | Standard Deviation 6.997 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -7.948 score on a scale | Standard Deviation 7.1614 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -9.531 score on a scale | Standard Deviation 9.5254 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -12.089 score on a scale | Standard Deviation 10.0806 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 31.646 score on a scale | Standard Deviation 9.3821 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -13.724 score on a scale | Standard Deviation 11.8173 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -12.839 score on a scale | Standard Deviation 13.1334 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -15.011 score on a scale | Standard Deviation 14.9433 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -14.883 score on a scale | Standard Deviation 14.9074 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.152 score on a scale | Standard Deviation 14.9552 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -13.383 score on a scale | Standard Deviation 14.5075 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -9.819 score on a scale | Standard Deviation 11.2688 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 34.413 score on a scale | Standard Deviation 12.6292 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.352 score on a scale | Standard Deviation 9.5528 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -9.660 score on a scale | Standard Deviation 9.8693 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 30.317 score on a scale | Standard Deviation 10.5425 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -13.251 score on a scale | Standard Deviation 14.2737 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -13.832 score on a scale | Standard Deviation 14.8785 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -13.996 score on a scale | Standard Deviation 12.0029 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -9.323 score on a scale | Standard Deviation 9.2809 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -15.079 score on a scale | Standard Deviation 12.8557 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -11.853 score on a scale | Standard Deviation 9.8578 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -13.538 score on a scale | Standard Deviation 13.2755 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -14.391 score on a scale | Standard Deviation 14.155 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -11.506 score on a scale | Standard Deviation 11.2985 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -14.706 score on a scale | Standard Deviation 14.9924 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -14.017 score on a scale | Standard Deviation 13.817 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -6.560 score on a scale | Standard Deviation 8.0631 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -15.549 score on a scale | Standard Deviation 14.3214 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -14.621 score on a scale | Standard Deviation 14.7575 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -14.732 score on a scale | Standard Deviation 14.5591 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.800 score on a scale | Standard Deviation 6.9371 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -14.166 score on a scale | Standard Deviation 13.8122 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -14.113 score on a scale | Standard Deviation 13.7397 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -14.289 score on a scale | Standard Deviation 15.0957 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -14.906 score on a scale | Standard Deviation 15.1056 |
| Extension Phase: Placebo | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -11.857 score on a scale | Standard Deviation 11.8911 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -5.458 score on a scale | Standard Deviation 6.1238 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 30.604 score on a scale | Standard Deviation 12.9983 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -4.754 score on a scale | Standard Deviation 7.0439 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -7.627 score on a scale | Standard Deviation 8.9115 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -10.438 score on a scale | Standard Deviation 10.8236 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -12.565 score on a scale | Standard Deviation 10.6334 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -13.112 score on a scale | Standard Deviation 10.9374 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -13.354 score on a scale | Standard Deviation 11.5619 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -14.858 score on a scale | Standard Deviation 12.5133 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -15.423 score on a scale | Standard Deviation 12.0649 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -14.150 score on a scale | Standard Deviation 11.6401 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -14.612 score on a scale | Standard Deviation 11.392 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -14.404 score on a scale | Standard Deviation 11.6971 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -14.912 score on a scale | Standard Deviation 12.1638 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -14.265 score on a scale | Standard Deviation 11.9806 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -14.904 score on a scale | Standard Deviation 11.8237 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -15.538 score on a scale | Standard Deviation 11.5883 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -15.492 score on a scale | Standard Deviation 11.6393 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -14.185 score on a scale | Standard Deviation 13.1359 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -14.619 score on a scale | Standard Deviation 12.0768 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -14.977 score on a scale | Standard Deviation 11.463 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -15.888 score on a scale | Standard Deviation 11.9316 |
| Extension Phase: E6011 100 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -15.419 score on a scale | Standard Deviation 11.9932 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.434 score on a scale | Standard Deviation 6.8409 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -14.322 score on a scale | Standard Deviation 9.4641 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -16.800 score on a scale | Standard Deviation 10.1413 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -17.514 score on a scale | Standard Deviation 12.1319 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -16.926 score on a scale | Standard Deviation 11.5097 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -12.688 score on a scale | Standard Deviation 9.5421 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -16.856 score on a scale | Standard Deviation 9.6991 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -16.258 score on a scale | Standard Deviation 11.2435 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -9.668 score on a scale | Standard Deviation 9.4114 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -17.233 score on a scale | Standard Deviation 11.9661 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -16.628 score on a scale | Standard Deviation 12.4186 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -17.069 score on a scale | Standard Deviation 11.6199 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -15.386 score on a scale | Standard Deviation 12.5672 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -8.050 score on a scale | Standard Deviation 6.9054 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -16.294 score on a scale | Standard Deviation 12.4571 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -15.442 score on a scale | Standard Deviation 11.2609 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 30.962 score on a scale | Standard Deviation 8.2366 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -16.818 score on a scale | Standard Deviation 11.9239 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -16.788 score on a scale | Standard Deviation 11.9283 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -15.476 score on a scale | Standard Deviation 13.3711 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -14.342 score on a scale | Standard Deviation 11.5579 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -17.282 score on a scale | Standard Deviation 11.4617 |
| Extension Phase: E6011 200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -17.076 score on a scale | Standard Deviation 9.496 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 36 | -20.687 score on a scale | Standard Deviation 14.6462 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 40 | -19.520 score on a scale | Standard Deviation 14.2756 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 28 | -18.889 score on a scale | Standard Deviation 13.9459 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 84 | -20.485 score on a scale | Standard Deviation 14.2038 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 64 | -20.611 score on a scale | Standard Deviation 12.3814 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 44 | -20.109 score on a scale | Standard Deviation 15.3423 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 12 | -14.861 score on a scale | Standard Deviation 15.0025 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 20 | -17.626 score on a scale | Standard Deviation 13.9147 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 80 | -20.822 score on a scale | Standard Deviation 13.5723 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 48 | -19.939 score on a scale | Standard Deviation 14.1463 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 72 | -20.348 score on a scale | Standard Deviation 12.9401 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 76 | -20.696 score on a scale | Standard Deviation 12.4896 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 68 | -21.280 score on a scale | Standard Deviation 12.9457 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 52 | -19.215 score on a scale | Standard Deviation 13.0405 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 8 | -13.926 score on a scale | Standard Deviation 13.7928 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Baseline | 33.915 score on a scale | Standard Deviation 11.9378 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 2 | -6.539 score on a scale | Standard Deviation 9.995 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 56 | -20.439 score on a scale | Standard Deviation 13.0531 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 24 | -17.698 score on a scale | Standard Deviation 13.726 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 16 | -16.617 score on a scale | Standard Deviation 14.1166 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 32 | -18.833 score on a scale | Standard Deviation 14.4014 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 60 | -20.746 score on a scale | Standard Deviation 13.3296 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Simple Disease Activity Index (SDAI) Values at Each Visit Based on LOCF | Change at Week 4 | -10.433 score on a scale | Standard Deviation 11.8548 |
Secondary
Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF
A total of 66 joints (minus 2 hip joints from evaluated tender 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.0 swollen joints | Standard Deviation 5.36 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -4.2 swollen joints | Standard Deviation 7.05 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -5.1 swollen joints | Standard Deviation 8.73 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -4.3 swollen joints | Standard Deviation 7.38 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -4.1 swollen joints | Standard Deviation 7.33 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.2 swollen joints | Standard Deviation 4.7 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -5.1 swollen joints | Standard Deviation 8.32 |
| Treatment Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 12.7 swollen joints | Standard Deviation 6.81 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -6.1 swollen joints | Standard Deviation 4.32 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -4.7 swollen joints | Standard Deviation 4.16 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.8 swollen joints | Standard Deviation 3.33 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -6.3 swollen joints | Standard Deviation 4.28 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -6.4 swollen joints | Standard Deviation 4.65 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 11.3 swollen joints | Standard Deviation 5.27 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -5.1 swollen joints | Standard Deviation 4.91 |
| Treatment Phase: E6011 100 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 3.42 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 12.4 swollen joints | Standard Deviation 4.89 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -5.6 swollen joints | Standard Deviation 5.71 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.9 swollen joints | Standard Deviation 4.18 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.3 swollen joints | Standard Deviation 4.66 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -5.9 swollen joints | Standard Deviation 6.38 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -5.2 swollen joints | Standard Deviation 5.3 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -4.9 swollen joints | Standard Deviation 5.39 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -3.8 swollen joints | Standard Deviation 5.82 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 13.5 swollen joints | Standard Deviation 6.41 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -3.4 swollen joints | Standard Deviation 5.25 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -5.0 swollen joints | Standard Deviation 4.95 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -6.0 swollen joints | Standard Deviation 5.81 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -5.7 swollen joints | Standard Deviation 6.41 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -6.6 swollen joints | Standard Deviation 6.6 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -6.4 swollen joints | Standard Deviation 7.26 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -6.2 swollen joints | Standard Deviation 6.65 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 80 | -7.2 swollen joints | Standard Deviation 7.5 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 84 | -7.7 swollen joints | Standard Deviation 7.38 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -7.3 swollen joints | Standard Deviation 7.18 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -7.5 swollen joints | Standard Deviation 7.67 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -5.9 swollen joints | Standard Deviation 4.11 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 12.7 swollen joints | Standard Deviation 6.48 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -6.0 swollen joints | Standard Deviation 4.65 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 76 | -7.7 swollen joints | Standard Deviation 7.21 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -7.2 swollen joints | Standard Deviation 7.19 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -7.4 swollen joints | Standard Deviation 6.83 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.9 swollen joints | Standard Deviation 4.21 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -7.4 swollen joints | Standard Deviation 7.55 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -7.0 swollen joints | Standard Deviation 6.5 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -7.2 swollen joints | Standard Deviation 8.04 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -7.0 swollen joints | Standard Deviation 5.86 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.8 swollen joints | Standard Deviation 3.94 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -7.9 swollen joints | Standard Deviation 7.49 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -7.2 swollen joints | Standard Deviation 6.77 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -7.9 swollen joints | Standard Deviation 7.04 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -6.9 swollen joints | Standard Deviation 7.75 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -8.0 swollen joints | Standard Deviation 7.3 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -7.2 swollen joints | Standard Deviation 7.52 |
| Extension Phase: Placebo | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -5.7 swollen joints | Standard Deviation 4.7 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -7.0 swollen joints | Standard Deviation 4.76 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -7.5 swollen joints | Standard Deviation 4.64 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -7.3 swollen joints | Standard Deviation 4.32 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -6.5 swollen joints | Standard Deviation 4.54 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -7.2 swollen joints | Standard Deviation 4.43 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -5.2 swollen joints | Standard Deviation 5.08 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -7.6 swollen joints | Standard Deviation 4.63 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 76 | -6.3 swollen joints | Standard Deviation 4.77 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -7.0 swollen joints | Standard Deviation 3.77 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -2.9 swollen joints | Standard Deviation 3.46 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -6.7 swollen joints | Standard Deviation 4.54 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -7.3 swollen joints | Standard Deviation 4.61 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -6.5 swollen joints | Standard Deviation 4.38 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -6.3 swollen joints | Standard Deviation 4.43 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 11.5 swollen joints | Standard Deviation 5.38 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -3.8 swollen joints | Standard Deviation 3.51 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -4.7 swollen joints | Standard Deviation 4.32 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 80 | -7.1 swollen joints | Standard Deviation 4.89 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -7.8 swollen joints | Standard Deviation 5.05 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 84 | -7.2 swollen joints | Standard Deviation 4.92 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -6.5 swollen joints | Standard Deviation 5.21 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -6.6 swollen joints | Standard Deviation 4.78 |
| Extension Phase: E6011 100 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -6.7 swollen joints | Standard Deviation 4.48 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -6.2 swollen joints | Standard Deviation 5.93 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 12.1 swollen joints | Standard Deviation 4.63 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -3.0 swollen joints | Standard Deviation 3.84 |
| Extension Phase: 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 4.03 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -3.8 swollen joints | Standard Deviation 5.42 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -5.2 swollen joints | Standard Deviation 4.93 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -5.5 swollen joints | Standard Deviation 4.81 |
| Extension Phase: E6011 200 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 5.28 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -6.9 swollen joints | Standard Deviation 5.71 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -7.0 swollen joints | Standard Deviation 6.17 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -7.1 swollen joints | Standard Deviation 5.9 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -6.8 swollen joints | Standard Deviation 5.1 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -6.8 swollen joints | Standard Deviation 5.44 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -6.4 swollen joints | Standard Deviation 6.11 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -6.3 swollen joints | Standard Deviation 5.03 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -6.3 swollen joints | Standard Deviation 5.89 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -6.5 swollen joints | Standard Deviation 6.4 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -6.4 swollen joints | Standard Deviation 6.21 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -6.9 swollen joints | Standard Deviation 5.79 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -6.9 swollen joints | Standard Deviation 5.93 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 76 | -7.1 swollen joints | Standard Deviation 5.81 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 80 | -6.7 swollen joints | Standard Deviation 6.18 |
| Extension Phase: E6011 200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 84 | -6.9 swollen joints | Standard Deviation 6.08 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 36 | -9.0 swollen joints | Standard Deviation 5.75 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 84 | -8.2 swollen joints | Standard Deviation 6.25 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 64 | -8.5 swollen joints | Standard Deviation 5.75 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 32 | -8.6 swollen joints | Standard Deviation 6.31 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 28 | -8.5 swollen joints | Standard Deviation 5.98 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 80 | -8.4 swollen joints | Standard Deviation 6.07 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 68 | -8.6 swollen joints | Standard Deviation 5.78 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 24 | -7.6 swollen joints | Standard Deviation 5.74 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 20 | -7.7 swollen joints | Standard Deviation 6.61 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 2 | -3.7 swollen joints | Standard Deviation 5.17 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 72 | -8.8 swollen joints | Standard Deviation 5.68 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 16 | -8.0 swollen joints | Standard Deviation 5.68 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 12 | -6.4 swollen joints | Standard Deviation 6.34 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Baseline | 13.8 swollen joints | Standard Deviation 6.18 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 76 | -8.3 swollen joints | Standard Deviation 5.59 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 52 | -8.3 swollen joints | Standard Deviation 5.3 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 8 | -6.7 swollen joints | Standard Deviation 5.74 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 56 | -8.6 swollen joints | Standard Deviation 5.7 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 48 | -8.5 swollen joints | Standard Deviation 5.82 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 44 | -8.3 swollen joints | Standard Deviation 6.32 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 4 | -5.5 swollen joints | Standard Deviation 5.01 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 60 | -8.5 swollen joints | Standard Deviation 6.17 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Swollen Joint Counts (SJC) at Each Visit Based on LOCF | Change at Week 40 | -8.4 swollen joints | Standard Deviation 5.64 |
Secondary
Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF)
A total of 68 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 reported for the Extension Phase from Baseline to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using LOCF imputation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 | -4.2 tender joints | Standard Deviation 7.4 |
| 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 | -5.3 tender joints | Standard Deviation 7.51 |
| 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 | -5.6 tender joints | Standard Deviation 8.5 |
| 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 | -2.9 tender joints | Standard Deviation 5.63 |
| 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 | -2.9 tender joints | Standard Deviation 6.04 |
| 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 | -3.9 tender joints | Standard Deviation 7 |
| 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 | -5.6 tender joints | Standard Deviation 7.97 |
| Treatment Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 13.7 tender joints | Standard Deviation 6.81 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -6.9 tender joints | Standard Deviation 7.33 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -6.4 tender joints | Standard Deviation 7.34 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 14.1 tender joints | Standard Deviation 7.24 |
| Treatment Phase: E6011 100 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 4.47 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -2.7 tender joints | Standard Deviation 5.05 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -6.9 tender joints | Standard Deviation 7.55 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -5.2 tender joints | Standard Deviation 6.83 |
| Treatment Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -4.6 tender joints | Standard Deviation 5.55 |
| Treatment Phase: 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 | -3.6 tender joints | Standard Deviation 5.99 |
| Treatment Phase: 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 | -4.5 tender joints | Standard Deviation 5.34 |
| Treatment Phase: 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 | -8.6 tender joints | Standard Deviation 7.38 |
| Treatment Phase: E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 16.3 tender joints | Standard Deviation 7.15 |
| Treatment Phase: 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 | -7.6 tender joints | Standard Deviation 7.72 |
| Treatment Phase: 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 | -8.4 tender joints | Standard Deviation 6.53 |
| Treatment Phase: 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 | -5.7 tender joints | Standard Deviation 6.14 |
| Treatment Phase: 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 | -7.1 tender joints | Standard Deviation 7.42 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -7.9 tender joints | Standard Deviation 10.33 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -7.9 tender joints | Standard Deviation 9.77 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -3.9 tender joints | Standard Deviation 6 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -5.8 tender joints | Standard Deviation 7.68 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -8.7 tender joints | Standard Deviation 9.93 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -6.7 tender joints | Standard Deviation 9.3 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 16.6 tender joints | Standard Deviation 9.61 |
| Treatment Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -8.5 tender joints | Standard Deviation 9.68 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -8.4 tender joints | Standard Deviation 7.94 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -8.4 tender joints | Standard Deviation 8.7 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -7.5 tender joints | Standard Deviation 8.12 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -3.2 tender joints | Standard Deviation 4.88 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -7.3 tender joints | Standard Deviation 9.3 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -8.0 tender joints | Standard Deviation 8.03 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -7.6 tender joints | Standard Deviation 7.9 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -7.9 tender joints | Standard Deviation 7.65 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 84 | -8.2 tender joints | Standard Deviation 8.08 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -3.0 tender joints | Standard Deviation 5.63 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -4.7 tender joints | Standard Deviation 6.12 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 13.6 tender joints | Standard Deviation 6.72 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 80 | -8.2 tender joints | Standard Deviation 8.29 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -5.0 tender joints | Standard Deviation 6.54 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -6.3 tender joints | Standard Deviation 6.53 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 76 | -8.2 tender joints | Standard Deviation 8.12 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -6.8 tender joints | Standard Deviation 7.7 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -6.8 tender joints | Standard Deviation 7.02 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -8.3 tender joints | Standard Deviation 8.23 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -7.6 tender joints | Standard Deviation 7.85 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -8.5 tender joints | Standard Deviation 8.15 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -8.1 tender joints | Standard Deviation 9.25 |
| Extension Phase: Placebo | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -8.3 tender joints | Standard Deviation 8.98 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -7.9 tender joints | Standard Deviation 6.39 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -4.6 tender joints | Standard Deviation 5.36 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 80 | -8.5 tender joints | Standard Deviation 6.37 |
| Extension Phase: E6011 100 mg | 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 4.44 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -7.7 tender joints | Standard Deviation 6.71 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -7.5 tender joints | Standard Deviation 6.59 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -7.2 tender joints | Standard Deviation 7.55 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -8.0 tender joints | Standard Deviation 6.68 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -7.6 tender joints | Standard Deviation 6.86 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -7.4 tender joints | Standard Deviation 6.33 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -7.5 tender joints | Standard Deviation 7.4 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -2.5 tender joints | Standard Deviation 5.01 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -7.5 tender joints | Standard Deviation 6.84 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -8.2 tender joints | Standard Deviation 6.59 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -7.9 tender joints | Standard Deviation 7 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -8.4 tender joints | Standard Deviation 6.24 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -6.6 tender joints | Standard Deviation 7.36 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 76 | -8.2 tender joints | Standard Deviation 6.63 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 14.3 tender joints | Standard Deviation 7.49 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -5.3 tender joints | Standard Deviation 6.83 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -8.7 tender joints | Standard Deviation 6.24 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -7.2 tender joints | Standard Deviation 7.31 |
| Extension Phase: E6011 100 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 84 | -8.0 tender joints | Standard Deviation 6.26 |
| Extension Phase: 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 | -8.9 tender joints | Standard Deviation 7.13 |
| Extension Phase: E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 15.7 tender joints | Standard Deviation 6.7 |
| Extension Phase: 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 | -3.4 tender joints | Standard Deviation 5.99 |
| Extension Phase: 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 | -4.5 tender joints | Standard Deviation 5.29 |
| Extension Phase: 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 | -5.7 tender joints | Standard Deviation 5.98 |
| Extension Phase: 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 | -7.3 tender joints | Standard Deviation 7.18 |
| Extension Phase: 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 | -8.6 tender joints | Standard Deviation 6.2 |
| Extension Phase: 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 | -7.8 tender joints | Standard Deviation 7.59 |
| Extension Phase: 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 | -9.5 tender joints | Standard Deviation 7.74 |
| Extension Phase: 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 | -8.6 tender joints | Standard Deviation 7.94 |
| Extension Phase: 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 | -9.4 tender joints | Standard Deviation 6.85 |
| Extension Phase: 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 | -9.9 tender joints | Standard Deviation 6.79 |
| Extension Phase: 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 | -9.9 tender joints | Standard Deviation 7.53 |
| Extension Phase: 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 | -9.4 tender joints | Standard Deviation 7.98 |
| Extension Phase: 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 | -10.2 tender joints | Standard Deviation 6.44 |
| Extension Phase: 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 | -9.1 tender joints | Standard Deviation 7.62 |
| Extension Phase: 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 | -10.0 tender joints | Standard Deviation 8.14 |
| Extension Phase: 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 | -9.0 tender joints | Standard Deviation 7.86 |
| Extension Phase: 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 | -9.7 tender joints | Standard Deviation 8.45 |
| Extension Phase: 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 | -9.8 tender joints | Standard Deviation 7.8 |
| Extension Phase: E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 76 | -10.5 tender joints | Standard Deviation 7.88 |
| Extension Phase: E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 80 | -10.5 tender joints | Standard Deviation 7.77 |
| Extension Phase: E6011 200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 84 | -10.5 tender joints | Standard Deviation 7.79 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 36 | -11.3 tender joints | Standard Deviation 10.32 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 84 | -11.7 tender joints | Standard Deviation 9.99 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 64 | -12.1 tender joints | Standard Deviation 8.76 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 32 | -10.0 tender joints | Standard Deviation 9.64 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 28 | -10.1 tender joints | Standard Deviation 9.92 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 80 | -11.8 tender joints | Standard Deviation 9.74 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 68 | -12.0 tender joints | Standard Deviation 9.58 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 24 | -10.4 tender joints | Standard Deviation 9.36 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 20 | -10.0 tender joints | Standard Deviation 9.06 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 2 | -4.5 tender joints | Standard Deviation 6.27 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 72 | -11.2 tender joints | Standard Deviation 10.02 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 16 | -9.3 tender joints | Standard Deviation 9.95 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 12 | -8.9 tender joints | Standard Deviation 10.1 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Baseline | 16.6 tender joints | Standard Deviation 9.07 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 76 | -11.8 tender joints | Standard Deviation 9.1 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 52 | -10.7 tender joints | Standard Deviation 9.44 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 8 | -7.6 tender joints | Standard Deviation 9.55 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 56 | -11.0 tender joints | Standard Deviation 8.98 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 48 | -10.9 tender joints | Standard Deviation 10.33 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 44 | -11.4 tender joints | Standard Deviation 10.59 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 4 | -6.7 tender joints | Standard Deviation 7.62 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 60 | -11.5 tender joints | Standard Deviation 9.18 |
| Extension Phase: E6011 400/200 mg | Change From Baseline in Tender Joint Counts (TJC) at Each Visit Based on Last Observation Carried Forward (LOCF) | Change at Week 40 | -10.7 tender joints | Standard Deviation 9.95 |
Secondary
Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI
The Disease Activity Score Based on 28-joints Count 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 reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: Treatment Phase: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 17 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 5 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 8 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 39 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 29 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 13 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 3 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 31 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 8 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 9 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 17 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 14 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 35 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 29 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 7 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 25 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 2 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 40 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 16 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 20 Participants |
| Treatment Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 11 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 0 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 15 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 12 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 6 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 6 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 10 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 5 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 8 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 21 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 20 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 15 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 1 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 6 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 12 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 8 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 1 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 7 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 5 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 11 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 13 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 14 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 27 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 23 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 12 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 19 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 8 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 18 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 2 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 23 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 21 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 17 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 13 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 18 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 22 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 15 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 14 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 34 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 14 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 17 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 19 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 3 Participants |
| Treatment Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 39 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 12 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 33 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 17 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 22 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 21 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 23 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 17 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 14 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 24 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 6 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 42 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 8 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 25 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 18 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 18 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 23 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 12 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 15 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 25 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 3 Participants |
| Treatment Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | No response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 3 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 10 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 34 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 2 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 13 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 12 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 33 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 5 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 18 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 12 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 19 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 23 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 12 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 11 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 8 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 20 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 11 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 19 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 19 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 11 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 21 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 9 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 11 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 20 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 13 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 18 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 25 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 22 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 12 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 18 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 9 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 14 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 12 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 8 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 17 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 19 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 23 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Good response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 7 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Moderate response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Good response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Moderate response | 14 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | No response | 18 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 22 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Good response | 15 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 29 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Moderate response | 16 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 13 Participants |
| Extension Phase: Placebo | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | No response | 16 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 0 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Good response | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 1 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | No response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Moderate response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 20 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Moderate response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 1 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | No response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 14 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 13 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 13 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Good response | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Moderate response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 19 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | No response | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 13 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 14 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 9 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 12 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 21 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 14 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 14 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 18 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 18 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 21 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 13 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 14 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 22 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 12 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 22 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 13 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 20 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 14 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 18 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 12 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 21 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 18 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 18 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Good response | 18 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Moderate response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | No response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Good response | 14 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Moderate response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | No response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Good response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Moderate response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | No response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 2 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 10 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 38 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 3 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 16 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 31 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 7 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 19 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 24 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 13 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 17 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 20 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 12 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 23 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 15 Participants |
| Extension Phase: E6011 200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | No response | 12 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Moderate response | 12 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 84 | Good response | 22 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | No response | 12 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Good response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | No response | 19 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Moderate response | 12 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 80 | Good response | 22 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | No response | 11 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Moderate response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 76 | Good response | 20 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | No response | 13 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | No response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Good response | 8 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Moderate response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 72 | Good response | 18 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | No response | 9 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Moderate response | 19 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 68 | Good response | 18 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | No response | 10 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Moderate response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | Moderate response | 21 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Moderate response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 64 | Good response | 19 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | No response | 12 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Moderate response | 16 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 60 | Good response | 18 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | No response | 11 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | Good response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 12 | No response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Moderate response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 56 | Good response | 21 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | No response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Moderate response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 52 | Good response | 18 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | No response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Moderate response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Good response | 12 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Moderate response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 48 | Good response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | No response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Moderate response | 16 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 44 | Good response | 16 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | No response | 11 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 24 | Good response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | Moderate response | 16 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Moderate response | 21 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 40 | Good response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | No response | 9 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Moderate response | 20 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 36 | Good response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | No response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 20 | No response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 16 | No response | 18 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Moderate response | 15 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 32 | Good response | 16 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | No response | 14 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Good response | 6 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | No response | 26 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Moderate response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 4 | Good response | 3 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | No response | 35 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 28 | Moderate response | 17 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 8 | Moderate response | 21 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Moderate response | 11 Participants |
| Extension Phase: E6011 400/200 mg | Number of Participants With a EULAR Good or Moderate Response Using DAS28-CRP at Each Visit Based on NRI | EULAR response at Week 2 | Good response | 0 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 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 reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: Treatment Phase: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI imputation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 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 | 5 Participants |
| 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 | 30 Participants |
| 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 | 7 Participants |
| 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 | 28 Participants |
| 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 | 19 Participants |
| 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 | 28 Participants |
| 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 | 20 Participants |
| 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 | 38 Participants |
| 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 |
| 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 | 6 Participants |
| 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 | 22 Participants |
| 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 | 15 Participants |
| 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 | 22 Participants |
| 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 | 37 Participants |
| 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 | 10 Participants |
| 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 | 18 Participants |
| 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 | 7 Participants |
| 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 | 29 Participants |
| 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 | 3 Participants |
| 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 | 19 Participants |
| 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 | 12 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 4 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 14 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 4 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 6 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 1 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 3 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 14 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 13 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 9 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 5 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 9 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 21 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 19 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 15 Participants |
| Treatment Phase: E6011 100 mg | Number of Participants With 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 | 13 Participants |
| Treatment Phase: 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 | 13 Participants |
| Treatment Phase: 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 | 13 Participants |
| Treatment Phase: 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 | 4 Participants |
| Treatment Phase: 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 |
| Treatment Phase: 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 | 27 Participants |
| Treatment Phase: 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 | 26 Participants |
| Treatment Phase: 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 | 15 Participants |
| Treatment Phase: 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 | 18 Participants |
| Treatment Phase: 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 | 22 Participants |
| Treatment Phase: 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 | 10 Participants |
| Treatment Phase: 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 | 29 Participants |
| Treatment Phase: 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 | 39 Participants |
| Treatment Phase: 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 | 26 Participants |
| Treatment Phase: 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 | 31 Participants |
| Treatment Phase: 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 | 24 Participants |
| Treatment Phase: 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 | 18 Participants |
| Treatment Phase: 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 | 10 Participants |
| Treatment Phase: 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 | 2 Participants |
| Treatment Phase: 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 | 10 Participants |
| Treatment Phase: 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 | 17 Participants |
| Treatment Phase: 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 | 23 Participants |
| Treatment Phase: E6011 400/200 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 | 42 Participants |
| Treatment Phase: E6011 400/200 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 | 21 Participants |
| Treatment Phase: E6011 400/200 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 | 20 Participants |
| Treatment Phase: E6011 400/200 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 |
| Treatment Phase: E6011 400/200 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 |
| Treatment Phase: E6011 400/200 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 | 20 Participants |
| Treatment Phase: E6011 400/200 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 | 32 Participants |
| Treatment Phase: E6011 400/200 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 | 7 Participants |
| Treatment Phase: E6011 400/200 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 | 28 Participants |
| Treatment Phase: E6011 400/200 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 | 19 Participants |
| Treatment Phase: E6011 400/200 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 | 11 Participants |
| Treatment Phase: E6011 400/200 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 | 19 Participants |
| Treatment Phase: E6011 400/200 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 | 11 Participants |
| Treatment Phase: E6011 400/200 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 | 24 Participants |
| Treatment Phase: E6011 400/200 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 | 9 Participants |
| Treatment Phase: E6011 400/200 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 | 24 Participants |
| Treatment Phase: E6011 400/200 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 | 21 Participants |
| Treatment Phase: E6011 400/200 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 | 13 Participants |
| Treatment Phase: E6011 400/200 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 | 23 Participants |
| Treatment Phase: E6011 400/200 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 | 18 Participants |
| Treatment Phase: E6011 400/200 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 | 13 Participants |
| Extension 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 | 16 Participants |
| Extension 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 36 | Moderate response | 25 Participants |
| Extension 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 60 | Good response | 14 Participants |
| Extension 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 68 | Moderate response | 17 Participants |
| Extension 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 68 | No response | 15 Participants |
| Extension 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 84 | Moderate response | 21 Participants |
| Extension 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 | 5 Participants |
| Extension 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 40 | No response | 16 Participants |
| Extension 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 | 24 Participants |
| Extension 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 | 11 Participants |
| Extension 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 56 | No response | 16 Participants |
| Extension 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 56 | Moderate response | 16 Participants |
| Extension 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 72 | Good response | 11 Participants |
| Extension 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 72 | Moderate response | 18 Participants |
| Extension 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 84 | No response | 14 Participants |
| Extension 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 40 | Moderate response | 19 Participants |
| Extension 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 | 10 Participants |
| Extension 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 | 31 Participants |
| Extension 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 56 | Good response | 15 Participants |
| Extension 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 52 | No response | 18 Participants |
| Extension 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 72 | No response | 18 Participants |
| Extension 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 76 | Good response | 11 Participants |
| Extension 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 | 14 Participants |
| Extension 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 | 32 Participants |
| Extension 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 | 21 Participants |
| Extension 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 84 | Good response | 12 Participants |
| Extension 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 52 | Moderate response | 15 Participants |
| Extension 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 52 | Good response | 14 Participants |
| Extension 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 76 | Moderate response | 19 Participants |
| Extension 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 76 | No response | 17 Participants |
| Extension 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 | 3 Participants |
| Extension 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 | 19 Participants |
| Extension 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 | 16 Participants |
| Extension 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 80 | No response | 18 Participants |
| Extension 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 48 | No response | 13 Participants |
| Extension 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 48 | Moderate response | 23 Participants |
| Extension 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 |
| Extension 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 80 | Good response | 13 Participants |
| Extension 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 28 | Moderate response | 22 Participants |
| Extension 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 36 | No response | 11 Participants |
| Extension 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 | 6 Participants |
| Extension 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 28 | No response | 14 Participants |
| Extension 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 48 | Good response | 11 Participants |
| Extension 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 44 | No response | 16 Participants |
| Extension 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 32 | Good response | 12 Participants |
| Extension 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 80 | Moderate response | 16 Participants |
| Extension 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 28 | Good response | 11 Participants |
| Extension 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 40 | Good response | 12 Participants |
| Extension 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 | 20 Participants |
| Extension 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 32 | Moderate response | 19 Participants |
| Extension 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 44 | Moderate response | 19 Participants |
| Extension 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 44 | Good response | 12 Participants |
| Extension 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 32 | No response | 16 Participants |
| Extension 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 | 21 Participants |
| Extension 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 36 | Good response | 11 Participants |
| Extension 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 64 | Good response | 14 Participants |
| Extension 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 64 | Moderate response | 18 Participants |
| Extension 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 | 7 Participants |
| Extension 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 | 7 Participants |
| Extension 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 | 25 Participants |
| Extension 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 60 | No response | 16 Participants |
| Extension 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 60 | Moderate response | 17 Participants |
| Extension 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 64 | No response | 15 Participants |
| Extension 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 68 | Good response | 15 Participants |
| Extension 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 | 17 Participants |
| Extension 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 | 21 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 100 mg | Number of Participants With 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 | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 17 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 100 mg | Number of Participants With 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 | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 18 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 13 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 3 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 13 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 4 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 14 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 4 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 13 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 4 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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: E6011 100 mg | Number of Participants With 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 | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 12 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 4 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With 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 | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 76 | Good response | 6 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 76 | Moderate response | 9 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 76 | No response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 80 | Good response | 5 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 80 | Moderate response | 11 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 80 | No response | 10 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 84 | Good response | 8 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 84 | Moderate response | 7 Participants |
| Extension Phase: E6011 100 mg | Number of Participants With a European League Against Rheumatism (EULAR) Good, Moderate or No Response Using DAS28-ESR at Each Visit Based on NRI | EULAR response at Week 84 | No response | 11 Participants |
| Extension Phase: 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 | 21 Participants |
| Extension Phase: 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 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 | 16 Participants |
| Extension Phase: 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 | 23 Participants |
| Extension Phase: 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 | 16 Participants |
| Extension Phase: 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 | 10 Participants |
| Extension Phase: 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 | 26 Participants |
| Extension Phase: 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 | 1 Participants |
| Extension Phase: 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 | 15 Participants |
| Extension Phase: 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 84 | Moderate response | 21 Participants |
| Extension Phase: 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 | 9 Participants |
| Extension Phase: 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 80 | No response | 17 Participants |
| Extension Phase: 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 | 19 Participants |
| Extension Phase: 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 | 11 Participants |
| Extension Phase: 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 | 3 Participants |
| Extension Phase: 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 | 11 Participants |
| Extension Phase: 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 | 16 Participants |
| Extension Phase: 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 80 | Good response | 12 Participants |
| Extension Phase: 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 | 27 Participants |
| Extension Phase: 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 | 14 Participants |
| Extension Phase: 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 | 13 Participants |
| Extension Phase: 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 84 | No response | 16 Participants |
| Extension Phase: 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 | 28 Participants |
| Extension Phase: 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 | 15 Participants |
| Extension Phase: 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 | 29 Participants |
| Extension Phase: 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 | 13 Participants |
| Extension Phase: 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 | 14 Participants |
| Extension Phase: 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 | 19 Participants |
| Extension Phase: 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 | 9 Participants |
| Extension Phase: 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 | 24 Participants |
| Extension Phase: 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 | 12 Participants |
| Extension Phase: 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 | 26 Participants |
| Extension Phase: 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 | 13 Participants |
| Extension Phase: 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 | 13 Participants |
| Extension Phase: 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 | 17 Participants |
| Extension Phase: 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 76 | No response | 18 Participants |
| Extension Phase: 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 | 26 Participants |
| Extension Phase: 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 | 12 Participants |
| Extension Phase: 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 | 13 Participants |
| Extension Phase: 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 84 | Good response | 13 Participants |
| Extension Phase: 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 | 11 Participants |
| Extension Phase: 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 | 35 Participants |
| Extension Phase: 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 | 17 Participants |
| Extension Phase: 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 | 18 Participants |
| Extension Phase: 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 | 12 Participants |
| Extension Phase: 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 | 23 Participants |
| Extension Phase: 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 | 27 Participants |
| Extension Phase: 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 | 9 Participants |
| Extension Phase: 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 | 29 Participants |
| Extension Phase: 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 | 29 Participants |
| Extension Phase: 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 | 16 Participants |
| Extension Phase: 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 | 21 Participants |
| Extension Phase: 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 | 9 Participants |
| Extension Phase: 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 | 14 Participants |
| Extension Phase: 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 | 10 Participants |
| Extension Phase: 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 | 22 Participants |
| Extension Phase: 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 | 15 Participants |
| Extension Phase: 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 80 | Moderate response | 21 Participants |
| Extension Phase: 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 | 13 Participants |
| Extension Phase: 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 76 | Good response | 16 Participants |
| Extension Phase: 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 | 24 Participants |
| Extension Phase: 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 | 15 Participants |
| Extension Phase: 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 | 14 Participants |
| Extension Phase: 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 | 21 Participants |
| Extension Phase: 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 | 11 Participants |
| Extension Phase: 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 76 | Moderate response | 16 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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: E6011 400/200 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 | 13 Participants |
| Extension Phase: E6011 400/200 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 400/200 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 | 22 Participants |
| Extension Phase: E6011 400/200 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 | 13 Participants |
| Extension Phase: E6011 400/200 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 | 11 Participants |
| Extension Phase: E6011 400/200 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 76 | Moderate response | 19 Participants |
| Extension Phase: E6011 400/200 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 | 14 Participants |
| Extension Phase: E6011 400/200 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 | 14 Participants |
| Extension Phase: E6011 400/200 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 | 20 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 23 Participants |
| Extension Phase: E6011 400/200 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 | 16 Participants |
| Extension Phase: E6011 400/200 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 76 | No response | 9 Participants |
| Extension Phase: E6011 400/200 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 | 18 Participants |
| Extension Phase: E6011 400/200 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 | 9 Participants |
| Extension Phase: E6011 400/200 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 | 35 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 14 Participants |
| Extension Phase: E6011 400/200 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 | 16 Participants |
| Extension Phase: E6011 400/200 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 | 23 Participants |
| Extension Phase: E6011 400/200 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 | 19 Participants |
| Extension Phase: E6011 400/200 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 | 9 Participants |
| Extension Phase: E6011 400/200 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 80 | Good response | 19 Participants |
| Extension Phase: E6011 400/200 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 | 15 Participants |
| Extension Phase: E6011 400/200 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 | 11 Participants |
| Extension Phase: E6011 400/200 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 | 19 Participants |
| Extension Phase: E6011 400/200 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 84 | Moderate response | 17 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 15 Participants |
| Extension Phase: E6011 400/200 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 | 15 Participants |
| Extension Phase: E6011 400/200 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 80 | Moderate response | 16 Participants |
| Extension Phase: E6011 400/200 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 | 23 Participants |
| Extension Phase: E6011 400/200 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 | 24 Participants |
| Extension Phase: E6011 400/200 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 | 10 Participants |
| Extension Phase: E6011 400/200 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 | 8 Participants |
| Extension Phase: E6011 400/200 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 | 17 Participants |
| Extension Phase: E6011 400/200 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 | 7 Participants |
| Extension Phase: E6011 400/200 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 | 20 Participants |
| Extension Phase: E6011 400/200 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 80 | No response | 11 Participants |
| Extension Phase: E6011 400/200 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 | 9 Participants |
| Extension Phase: E6011 400/200 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 | 26 Participants |
| Extension Phase: E6011 400/200 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 | 18 Participants |
| Extension Phase: E6011 400/200 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 84 | No response | 12 Participants |
| Extension Phase: E6011 400/200 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 | 23 Participants |
| Extension Phase: E6011 400/200 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 | 13 Participants |
| Extension Phase: E6011 400/200 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 | 10 Participants |
| Extension Phase: E6011 400/200 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 | 16 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 18 Participants |
| Extension Phase: E6011 400/200 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 | 22 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 21 Participants |
| Extension Phase: E6011 400/200 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 | 14 Participants |
| Extension Phase: E6011 400/200 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 | 12 Participants |
| Extension Phase: E6011 400/200 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 | 22 Participants |
| Extension Phase: E6011 400/200 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 | 13 Participants |
| Extension Phase: E6011 400/200 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 | 10 Participants |
| Extension Phase: E6011 400/200 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 84 | Good response | 17 Participants |
| Extension Phase: E6011 400/200 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 | 13 Participants |
| Extension Phase: E6011 400/200 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 | 10 Participants |
| Extension Phase: E6011 400/200 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 | 21 Participants |
| Extension Phase: E6011 400/200 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 76 | Good response | 18 Participants |
| Extension Phase: E6011 400/200 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 | 23 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 68 \<=1; CRP \<=1 mg/dL; and disease activity assessments VAS (mm) by participants \<=1. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| 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 |
| 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 |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 1.9 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 3.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 7.1 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 3.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 3.6 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 3.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 5.6 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 3.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 1.9 percentage of participants |
| Treatment Phase: 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 |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 3.7 percentage of participants |
| Treatment Phase: 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 |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 3.7 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 5.6 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 9.3 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 3.7 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 2.1 percentage of participants |
| Extension Phase: Placebo | 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 | 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 | 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 | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 0.0 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 4.3 percentage of participants |
| Extension Phase: Placebo | 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 | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 36 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 4.3 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 48 | 4.3 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 4.3 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 76 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 80 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 84 | 8.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 76 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 7.7 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 7.7 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 7.7 percentage of participants |
| Extension Phase: E6011 100 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 100 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 100 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 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 80 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 7.7 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 3.8 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 3.8 percentage of participants |
| Extension Phase: E6011 100 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 100 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 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 7.7 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 3.8 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 3.8 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 84 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 7.7 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 7.7 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 32 | 6.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 4.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 14.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 76 | 4.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 84 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 6.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 80 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 4.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 4.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 4 | 2.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 4.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 84 | 19.6 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 64 | 8.7 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 80 | 19.6 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 36 | 8.7 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 12 | 4.3 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 68 | 8.7 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 72 | 15.2 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 24 | 6.5 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 32 | 8.7 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 52 | 8.7 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 16 | 4.3 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 76 | 15.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 20 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 56 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 48 | 15.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 44 | 8.7 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 28 | 6.5 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 60 | 6.5 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved Boolean Remission at Each Visit Based on NRI | Remission at Week 40 | 8.7 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, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-76. CDAI score of 22 or above = high disease activity, a value between 10 and 22 = moderate disease activity and value less than or equal to \<=10 = low disease activity. Higher scores indicated higher disease activity. CDAI Remission was defined as CDAI score \<=2.8. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: 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, 72, 76, 80, and 84
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 3.7 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.4 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 5.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.1 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 10.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 7.1 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 10.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 5.6 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.4 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 3.7 percentage of participants |
| Treatment Phase: 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 |
| Treatment Phase: 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 |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.4 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 1.9 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 1.9 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 9.3 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 9.3 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 3.7 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 4.3 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 17.0 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 19.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 12.8 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 19.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 19.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 14.9 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 7.7 percentage of participants |
| Extension Phase: E6011 100 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: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 11.5 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 11.5 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 15.4 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 7.7 percentage of participants |
| Extension Phase: E6011 100 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 100 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 100 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 100 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 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 11.5 percentage of participants |
| Extension Phase: E6011 100 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 100 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: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 19.2 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 23.1 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 3.8 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 19.2 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 12.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 12.0 percentage of participants |
| Extension Phase: 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 |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 16.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 12.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 10.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 14.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 2.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 12.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 4.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 2.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 8.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 23.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 23.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 15.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 2.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 19.6 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 17.4 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 4.3 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 19.6 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 17.4 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 19.6 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 15.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved CDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 13.0 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, swollen joint counts of 28, participant's global assessment of disease activity, physician global assessment of disease activity score, and CRP value. Total score ranged between 0-86. SDAI score of 26 or above = high disease activity, a value between 11 and 26 = moderate disease activity and value \<=11 = low disease activity. Higher scores indicated higher disease activity. SDAI Remission was defined as SDAI score \<=3.3. Data reported for the Extension Phase from Week 2 to Week 24, is the same data for the Treatment Phase, but excluding the participants who did not gave consent to participate in Extension Phase.
Time frame: Treatment Phase: 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, 72, 76, 80, 84, 88, 92, 96, 100, and 104
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Here number analyzed n are the participants who were evaluable for the outcome measure for given time points. Missing data was imputed using NRI.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 3.7 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.4 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 1.9 percentage of participants |
| 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 |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 5.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.1 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 10.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 3.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 10.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 14.3 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 5.6 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 7.4 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 3.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 1.9 percentage of participants |
| Treatment Phase: 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 |
| Treatment Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 7.4 percentage of participants |
| Treatment Phase: 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 |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 1.9 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 11.1 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 9.3 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 3.7 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 2.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 2 | 2.1 percentage of participants |
| Extension Phase: Placebo | 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 | 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 | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 4.3 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 6.4 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 8.5 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 12.8 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 17.0 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 17.0 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 14.9 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 12.8 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 19.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 10.6 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 19.1 percentage of participants |
| Extension Phase: Placebo | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 17.0 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 19.2 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 19.2 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 19.2 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 8 | 3.8 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 15.4 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 15.4 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 11.5 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 11.5 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 11.5 percentage of participants |
| Extension Phase: E6011 100 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 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 15.4 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 23.1 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 23.1 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 7.7 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 19.2 percentage of participants |
| Extension Phase: E6011 100 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 19.2 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 14.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 10.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 14.0 percentage of participants |
| Extension Phase: 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 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 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 12.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 16.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 12.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 12.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 6.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 16.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 4.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 12.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 4.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 8.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 6.0 percentage of participants |
| Extension Phase: 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 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 4 | 2.0 percentage of participants |
| Extension Phase: E6011 200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 8.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 84 | 23.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 64 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 80 | 26.1 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 36 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 12 | 2.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 68 | 17.4 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 72 | 19.6 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 24 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 32 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 52 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 16 | 4.3 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 76 | 17.4 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 20 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 56 | 17.4 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 48 | 21.7 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 44 | 15.2 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 28 | 10.9 percentage of participants |
| Extension Phase: E6011 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 60 | 13.0 percentage of participants |
| Extension Phase: E6011 400/200 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 400/200 mg | Percentage of Participants Who Achieved SDAI Remission at Each Visit Based on NRI | Remission at Week 40 | 15.2 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 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.
Time frame: Weeks 2, 4, 8, 16, 20, and 24
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 13.0 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 18.5 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 40.7 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 46.3 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 33.3 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 35.2 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 39.3 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 46.4 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 14.3 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 35.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 28.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 50.0 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 24.1 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 37.0 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 51.9 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 53.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 59.3 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 22.2 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 55.6 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 57.4 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 31.5 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 53.7 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 20.4 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR20 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 46.3 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 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.
Time frame: Weeks 2, 4, 8, 16, 20, and 24
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 14.8 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 14.8 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 16.7 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 7.4 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 14.8 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 10.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 10.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 14.3 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 17.9 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 17.9 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 3.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 25.9 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 7.4 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 3.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 3.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 20.4 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 31.5 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 25.9 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 9.3 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 27.8 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 25.9 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 9.3 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 7.4 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 22.2 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR50 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 18.5 percentage of participants |
Secondary
Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 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.
Time frame: Weeks 2, 4, 8, 16, 20, and 24
Population: FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 postdose primary efficacy measurement. Missing data was imputed using NRI and this Outcome Measure was planned to be assessed only in Treatment Phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 5.6 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 5.6 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 5.6 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 1.9 percentage of participants |
| Treatment Phase: Placebo | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 3.7 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 7.1 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 3.6 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 7.1 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 14.3 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 100 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 9.3 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 1.9 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 0.0 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 0.0 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 3.7 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 11.1 percentage of participants |
| Treatment Phase: E6011 200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 11.1 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 8 | 5.6 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 24 | 13.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 20 | 14.8 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 4 | 1.9 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 2 | 0.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 16 | 13.0 percentage of participants |
| Treatment Phase: E6011 400/200 mg | Treatment Phase: Percentage of Participants Who Achieved an ACR70 Response at Weeks 2, 4, 8, 16, 20 and 24 Based on NRI | Response at Week 12 | 7.4 percentage of participants |