Arthritis, Rheumatoid
Conditions
Keywords
Smyraf, Rheumatoid Arthritis, Peficitinib, ASP015K
Brief summary
This study evaluated the safety and efficacy of long-term administration of ASP015K in patients who have completed Phase IIb or Phase III studies.
Detailed description
This study was an extension study conducted as an open-label multicenter study in rheumatoid arthritis (RA) participants who completed the Phase IIb Study of ASP015K \[015K-CL-RAJ1 (hereinafter referred to as study RAJ1)\], Phase III Study of ASP015K \[015K-CL-RAJ3 (RAJ3)\], or Phase III Study of ASP015K \[015K-CL-RAJ4 (RAJ4)\]. After the marketing approval in Japan on 26 Mar 2019, this study continued as post marketing clinical study in Japan. In Taiwan and Korea, this study continued as clinical study. Participants received oral ASP015K once daily (QD) after breakfast. The ASP015K dose was increased later for participants who have no safety problems but showed lack of efficacy. The duration of treatment with the study drug was differed depending upon the participants.
Interventions
DRUGPeficitinib
Oral Tablet
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as specified in the protocol * The subject himself/herself wishes to continue taking the study drug, and the investigator or sub-investigator deems continued administration to be necessary or appropriate
Exclusion criteria
* There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic infection, tuberculosis infection, or malignancy is suspected * Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for human immunodeficiency virus (HIV) infection * Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or a history of it * Subject has a clinically significant infection or disease (requiring hospitalization or parenteral therapy) * Subject has QTc \< 300 msec on ECG measurements performed at the study site at Week 52 of studies RAJ3 or RAJ4 and has QTc \< 300 msec at retest.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | Baseline up to end of study (EOS) (up to week 376) | AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an ACR50-CRP Response Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. |
| Percentage of Participants With an ACR70-CRP Response Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit. |
| Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit. |
| Percentage of Participants With an ACR50-ESR Response Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. |
| Percentage of Participants With an ACR70-ESR Response Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit. |
| Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. |
| Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. |
| Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission, DAS28-CRP \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity. |
| Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission, DAS28-ESR \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity. |
| Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission. |
| Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission. |
| Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity. |
| Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity. |
| Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | Higher CRP indicates greater disease activity. |
| Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | Higher ESR indicates greater disease activity. |
| Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). |
| Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | 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. Percentage of participants with good response have been reported in this outcome measure. |
| Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | 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. Percentage of participants with good response have been reported in the outcome measure. |
| Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | 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. Percentage of participants with good or moderate response have been reported in this outcome measure. |
| Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | 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. Percentage of participants with good or moderate response have been reported in this outcome measure. |
| Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3. |
| Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. |
| Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8. |
| Change From Baseline of Preceding Study CDAI Score Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. |
| Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOS | FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue. |
| Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline. |
| Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline. |
| Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. Negative values indicate improvement from baseline. |
| Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline. |
| Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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. |
| Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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. |
| Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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. |
| Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly. |
| Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. |
| Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain. |
| Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. |
| Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS | ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT. |
| Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. |
| Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. |
| Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. |
| Number of Participants Who Withdrew Due to Lack of Efficacy | Baseline up to week 372 | Participants who discontinued due to lack of efficacy have been reported. |
| Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. |
Countries
Japan, South Korea, Taiwan
Participant flow
Recruitment details
Participants who completed 015K-CL-RAJ1 (NCT01649999), 015K-CL-RAJ3 (NCT02308163), 015K-CL-RAJ4 (NCT02305849) and met eligible criteria were enrolled in this study. Participants in the etanercept group in study 015K-CL-RAJ3 (NCT01649999) were not included in this study.
Pre-assignment details
For participants who were on 50mg at the time of peficitinib approval, dose was increased to 100mg. Participants whose dose increment was not possible were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Participants Who Completed 015K-CL-RAJ1 Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved. | 201 |
| Participants Who Completed 015K-CL-RAJ3 Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved. | 224 |
| Participants Who Completed 015K-CL-RAJ4 Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved. | 412 |
| Total | 837 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 36 | 29 | 48 |
| Overall Study | Lack of Efficacy | 39 | 11 | 14 |
| Overall Study | Met discontinuation criteria | 4 | 0 | 7 |
| Overall Study | Miscellaneous | 25 | 19 | 23 |
| Overall Study | Not met inclusion or exclusion criteria | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 10 | 7 | 11 |
| Overall Study | Subject Lost to Follow up | 1 | 0 | 1 |
| Overall Study | Withdrawal of Consent | 16 | 12 | 16 |
Baseline characteristics
| Characteristic | Participants Who Completed 015K-CL-RAJ1 | Total | Participants Who Completed 015K-CL-RAJ4 | Participants Who Completed 015K-CL-RAJ3 |
|---|---|---|---|---|
| Age, Continuous | 52.7 Years STANDARD_DEVIATION 11.3 | 55.6 Years STANDARD_DEVIATION 11.9 | 57.2 Years STANDARD_DEVIATION 11.5 | 55.2 Years STANDARD_DEVIATION 12.8 |
| C-Reactive Protein (CRP) | 2.214 Milligram per deciliter STANDARD_DEVIATION 2.379 | 2.331 Milligram per deciliter STANDARD_DEVIATION 2.136 | 2.476 Milligram per deciliter STANDARD_DEVIATION 2.077 | 2.167 Milligram per deciliter STANDARD_DEVIATION 2 |
| Erythrocyte Sedimentation Rate (ESR) | 44.8 Millimeter per hour (mm/h) STANDARD_DEVIATION 22.2 | 48.3 Millimeter per hour (mm/h) STANDARD_DEVIATION 25.3 | 50.7 Millimeter per hour (mm/h) STANDARD_DEVIATION 26.2 | 47.0 Millimeter per hour (mm/h) STANDARD_DEVIATION 25.9 |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) | 0.89 Units on a scale STANDARD_DEVIATION 0.63 | 0.96 Units on a scale STANDARD_DEVIATION 0.65 | 1.00 Units on a scale STANDARD_DEVIATION 0.65 | 0.93 Units on a scale STANDARD_DEVIATION 0.67 |
| Physician's Global Assessment of Arthritis | 55.68 Units on a scale STANDARD_DEVIATION 20.66 | 58.3 Units on a scale STANDARD_DEVIATION 19.93 | 59.47 Units on a scale STANDARD_DEVIATION 19.7 | 58.52 Units on a scale STANDARD_DEVIATION 19.55 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 201 Participants | 837 Participants | 412 Participants | 224 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 158 Participants | 614 Participants | 293 Participants | 163 Participants |
| Sex: Female, Male Male | 43 Participants | 223 Participants | 119 Participants | 61 Participants |
| Subject's Global Assessment of Arthritis | 56.15 Units on a scale STANDARD_DEVIATION 25.1 | 55.81 Units on a scale STANDARD_DEVIATION 25.06 | 54.79 Units on a scale STANDARD_DEVIATION 24.94 | 57.40 Units on a scale STANDARD_DEVIATION 25.24 |
| Subject's Global Assessment of Arthritis Pain | 56.12 Units on a scale STANDARD_DEVIATION 24.71 | 55.35 Units on a scale STANDARD_DEVIATION 25.36 | 54.19 Units on a scale STANDARD_DEVIATION 25.63 | 56.79 Units on a scale STANDARD_DEVIATION 25.44 |
| Swollen Joint Count (66 Joints) | 12.0 Swollen joint count STANDARD_DEVIATION 6.1 | 12.7 Swollen joint count STANDARD_DEVIATION 6.7 | 13.1 Swollen joint count STANDARD_DEVIATION 6.9 | 12.4 Swollen joint count STANDARD_DEVIATION 6.7 |
| Tender Joint Count (68 Joints) | 15.1 Tender joint count STANDARD_DEVIATION 9.3 | 15 Tender joint count STANDARD_DEVIATION 9.2 | 14.9 Tender joint count STANDARD_DEVIATION 8.9 | 15.0 Tender joint count STANDARD_DEVIATION 9.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 201 | 1 / 225 | 1 / 417 |
| other Total, other adverse events | 181 / 201 | 174 / 225 | 358 / 417 |
| serious Total, serious adverse events | 59 / 201 | 56 / 225 | 84 / 417 |
Outcome results
Primary
Number of Participants With Adverse Events
AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug.
Time frame: Baseline up to end of study (EOS) (up to week 376)
Population: Safety Population: All participants who received at least 1 dose of the study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | AE leading to dose reduction of study drug | 4 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | AE leading to temporary discontinuation of drug | 81 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | DSAE leading to permanent discontinuation of drug | 11 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | Grade 3 or higher in severity AE | 75 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | DAE leading to temporary discontinuation of drug | 67 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | SAE leading to permanent discontinuation of drug | 23 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | AE leading to permanent discontinuation of study | 50 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | Drug Related serious AE (DSAE) | 22 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | DAE leading to permanent discontinuation of drug | 30 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | DAE leading to dose reduction of study drug | 4 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | Deaths | 0 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | Drug related AE (DAE) | 175 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | Adverse Events (AE) | 193 Participants |
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants With Adverse Events | Serious AE (SAE) | 59 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | AE leading to dose reduction of study drug | 8 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | Serious AE (SAE) | 56 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | SAE leading to permanent discontinuation of drug | 20 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | Adverse Events (AE) | 208 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | Drug related AE (DAE) | 160 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | Deaths | 1 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | Drug Related serious AE (DSAE) | 37 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | Grade 3 or higher in severity AE | 73 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | AE leading to permanent discontinuation of study | 34 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | DAE leading to permanent discontinuation of drug | 18 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | DSAE leading to permanent discontinuation of drug | 12 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | DAE leading to dose reduction of study drug | 8 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | AE leading to temporary discontinuation of drug | 86 Participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants With Adverse Events | DAE leading to temporary discontinuation of drug | 76 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | Drug Related serious AE (DSAE) | 54 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | AE leading to temporary discontinuation of drug | 191 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | Serious AE (SAE) | 84 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | Deaths | 1 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | AE leading to dose reduction of study drug | 6 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | Drug related AE (DAE) | 321 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | Adverse Events (AE) | 395 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | DAE leading to dose reduction of study drug | 6 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | DSAE leading to permanent discontinuation of drug | 27 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | AE leading to permanent discontinuation of study | 56 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | DAE leading to temporary discontinuation of drug | 158 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | DAE leading to permanent discontinuation of drug | 44 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | Grade 3 or higher in severity AE | 118 Participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants With Adverse Events | SAE leading to permanent discontinuation of drug | 32 Participants |
Secondary
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 276 | -2.84 units on a scale | Standard Deviation 1.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 132 | -2.67 units on a scale | Standard Deviation 1.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | EOT | -2.14 units on a scale | Standard Deviation 1.61 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 264 | -2.75 units on a scale | Standard Deviation 1.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 144 | -2.76 units on a scale | Standard Deviation 1.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 16 | -1.83 units on a scale | Standard Deviation 1.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 252 | -2.83 units on a scale | Standard Deviation 1.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 156 | -2.67 units on a scale | Standard Deviation 1.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 20 | -1.88 units on a scale | Standard Deviation 1.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 216 | -2.73 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 168 | -2.68 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 24 | -1.96 units on a scale | Standard Deviation 1.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 204 | -2.79 units on a scale | Standard Deviation 1.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 180 | -2.64 units on a scale | Standard Deviation 1.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 372 | -5.13 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 192 | -2.73 units on a scale | Standard Deviation 1.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 28 | -2.05 units on a scale | Standard Deviation 1.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 32 | -2.03 units on a scale | Standard Deviation 1.24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 36 | -2.14 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 0 | -0.70 units on a scale | Standard Deviation 1.09 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 360 | -3.07 units on a scale | Standard Deviation 1.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 40 | -2.18 units on a scale | Standard Deviation 1.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 44 | -2.28 units on a scale | Standard Deviation 1.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 48 | -2.28 units on a scale | Standard Deviation 1.22 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 228 | -2.80 units on a scale | Standard Deviation 1.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 348 | -2.52 units on a scale | Standard Deviation 1.33 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 60 | -2.32 units on a scale | Standard Deviation 1.26 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | EOS | -1.58 units on a scale | Standard Deviation 1.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 336 | -2.62 units on a scale | Standard Deviation 1.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 72 | -2.39 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 2 | -1.03 units on a scale | Standard Deviation 1.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 324 | -2.84 units on a scale | Standard Deviation 1.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 84 | -2.45 units on a scale | Standard Deviation 1.33 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 4 | -1.11 units on a scale | Standard Deviation 1.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 312 | -2.77 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 96 | -2.59 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 8 | -1.43 units on a scale | Standard Deviation 1.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 300 | -2.76 units on a scale | Standard Deviation 1.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 108 | -2.64 units on a scale | Standard Deviation 1.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 12 | -1.66 units on a scale | Standard Deviation 1.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 288 | -2.77 units on a scale | Standard Deviation 1.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 120 | -2.54 units on a scale | Standard Deviation 1.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 240 | -2.83 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 156 | -3.14 units on a scale | Standard Deviation 1.52 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 0 | -2.70 units on a scale | Standard Deviation 1.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 12 | -2.68 units on a scale | Standard Deviation 1.41 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 36 | -2.85 units on a scale | Standard Deviation 1.44 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 48 | -2.82 units on a scale | Standard Deviation 1.42 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 60 | -2.78 units on a scale | Standard Deviation 1.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 72 | -2.91 units on a scale | Standard Deviation 1.44 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 84 | -2.81 units on a scale | Standard Deviation 1.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 96 | -2.84 units on a scale | Standard Deviation 1.45 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 108 | -2.92 units on a scale | Standard Deviation 1.52 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 120 | -3.05 units on a scale | Standard Deviation 1.48 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 132 | -2.98 units on a scale | Standard Deviation 1.58 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 144 | -3.00 units on a scale | Standard Deviation 1.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 24 | -2.71 units on a scale | Standard Deviation 1.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 168 | -3.13 units on a scale | Standard Deviation 1.69 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 180 | -3.08 units on a scale | Standard Deviation 1.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 192 | -3.25 units on a scale | Standard Deviation 1.52 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 204 | -3.04 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | EOT | -2.69 units on a scale | Standard Deviation 1.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | EOS | -2.00 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 0 | -2.83 units on a scale | Standard Deviation 1.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 204 | -4.29 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 156 | -3.32 units on a scale | Standard Deviation 1.4 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 144 | -3.30 units on a scale | Standard Deviation 1.36 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 132 | -3.33 units on a scale | Standard Deviation 1.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 120 | -3.26 units on a scale | Standard Deviation 1.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 108 | -3.31 units on a scale | Standard Deviation 1.25 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 96 | -3.21 units on a scale | Standard Deviation 1.18 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 84 | -3.20 units on a scale | Standard Deviation 1.28 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 72 | -3.22 units on a scale | Standard Deviation 1.28 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 60 | -3.11 units on a scale | Standard Deviation 1.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 48 | -3.13 units on a scale | Standard Deviation 1.27 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 36 | -3.07 units on a scale | Standard Deviation 1.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 24 | -2.99 units on a scale | Standard Deviation 1.29 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 12 | -2.90 units on a scale | Standard Deviation 1.33 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | EOS | -2.13 units on a scale | Standard Deviation 1.41 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 180 | -3.38 units on a scale | Standard Deviation 1.31 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | EOT | -3.11 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 192 | -3.11 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372 | Week 168 | -3.18 units on a scale | Standard Deviation 1.27 |
Secondary
Change From Baseline of Preceding Study CDAI Score Through Week 372
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 24 | -17.37 units on a scale | Standard Deviation 11.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 264 | -22.86 units on a scale | Standard Deviation 12.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 144 | -21.97 units on a scale | Standard Deviation 11.87 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 2 | -9.38 units on a scale | Standard Deviation 10.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 252 | -22.98 units on a scale | Standard Deviation 12.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 156 | -21.77 units on a scale | Standard Deviation 11.89 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 372 | -50.85 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 240 | -23.11 units on a scale | Standard Deviation 11.88 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 168 | -22.06 units on a scale | Standard Deviation 12.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 28 | -18.06 units on a scale | Standard Deviation 11.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 228 | -22.73 units on a scale | Standard Deviation 11.89 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 180 | -21.90 units on a scale | Standard Deviation 12.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 32 | -17.36 units on a scale | Standard Deviation 11.37 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 216 | -22.62 units on a scale | Standard Deviation 11.84 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 192 | -22.24 units on a scale | Standard Deviation 12.55 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 36 | -18.29 units on a scale | Standard Deviation 10.42 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 204 | -22.95 units on a scale | Standard Deviation 11.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 4 | -10.19 units on a scale | Standard Deviation 11.36 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 360 | -25.05 units on a scale | Standard Deviation 10.77 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 40 | -18.90 units on a scale | Standard Deviation 10.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 44 | -19.60 units on a scale | Standard Deviation 10.58 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 48 | -19.80 units on a scale | Standard Deviation 11.03 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 8 | -13.30 units on a scale | Standard Deviation 11.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 348 | -21.08 units on a scale | Standard Deviation 11.11 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 60 | -19.79 units on a scale | Standard Deviation 11.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 12 | -15.11 units on a scale | Standard Deviation 11.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 336 | -22.23 units on a scale | Standard Deviation 11.56 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 72 | -20.19 units on a scale | Standard Deviation 12.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | EOS | -13.84 units on a scale | Standard Deviation 13.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 324 | -23.89 units on a scale | Standard Deviation 11.85 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 84 | -20.40 units on a scale | Standard Deviation 12.11 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 0 | -7.07 units on a scale | Standard Deviation 10.78 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 312 | -23.26 units on a scale | Standard Deviation 12.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 96 | -20.92 units on a scale | Standard Deviation 11.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | EOT | -18.05 units on a scale | Standard Deviation 13.98 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 300 | -23.02 units on a scale | Standard Deviation 12.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 108 | -21.17 units on a scale | Standard Deviation 11.87 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 16 | -16.35 units on a scale | Standard Deviation 10.88 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 288 | -23.13 units on a scale | Standard Deviation 12.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 120 | -20.68 units on a scale | Standard Deviation 12.79 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 20 | -16.87 units on a scale | Standard Deviation 11.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 276 | -23.58 units on a scale | Standard Deviation 11.91 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 132 | -21.46 units on a scale | Standard Deviation 12.3 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 84 | -23.20 units on a scale | Standard Deviation 12.61 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 0 | -22.70 units on a scale | Standard Deviation 12.24 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 12 | -22.39 units on a scale | Standard Deviation 12.28 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 24 | -22.62 units on a scale | Standard Deviation 12.17 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 36 | -23.41 units on a scale | Standard Deviation 12.39 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 48 | -23.32 units on a scale | Standard Deviation 11.98 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 60 | -23.01 units on a scale | Standard Deviation 12.53 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 72 | -23.45 units on a scale | Standard Deviation 12.39 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 96 | -23.81 units on a scale | Standard Deviation 12.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 108 | -23.81 units on a scale | Standard Deviation 12.76 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 120 | -24.84 units on a scale | Standard Deviation 12.73 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 132 | -24.86 units on a scale | Standard Deviation 13.57 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 144 | -25.06 units on a scale | Standard Deviation 14.11 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 156 | -26.95 units on a scale | Standard Deviation 14.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 168 | -25.34 units on a scale | Standard Deviation 14.99 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 180 | -24.54 units on a scale | Standard Deviation 14.26 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 192 | -22.87 units on a scale | Standard Deviation 14.41 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 204 | -25.35 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | EOT | -22.24 units on a scale | Standard Deviation 13.54 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | EOS | -17.97 units on a scale | Standard Deviation 12.75 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 180 | -26.81 units on a scale | Standard Deviation 13.07 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 168 | -25.13 units on a scale | Standard Deviation 12.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 156 | -25.64 units on a scale | Standard Deviation 12.5 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 144 | -25.23 units on a scale | Standard Deviation 12.1 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 132 | -25.77 units on a scale | Standard Deviation 11.56 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 120 | -25.74 units on a scale | Standard Deviation 11.66 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 108 | -26.22 units on a scale | Standard Deviation 11.82 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 96 | -25.54 units on a scale | Standard Deviation 11.27 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 84 | -25.16 units on a scale | Standard Deviation 11.54 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 72 | -25.29 units on a scale | Standard Deviation 11.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 60 | -24.66 units on a scale | Standard Deviation 11.53 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 48 | -24.66 units on a scale | Standard Deviation 11.45 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 36 | -24.42 units on a scale | Standard Deviation 11.13 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 24 | -23.93 units on a scale | Standard Deviation 11.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 12 | -23.21 units on a scale | Standard Deviation 11.54 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | EOS | -18.78 units on a scale | Standard Deviation 12.87 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | EOT | -24.74 units on a scale | Standard Deviation 12.26 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 192 | -25.93 units on a scale | Standard Deviation 12.65 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 0 | -23.22 units on a scale | Standard Deviation 11.73 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study CDAI Score Through Week 372 | Week 204 | -35.05 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Higher CRP indicates greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 24 | -1.237 mg/dL | Standard Deviation 2.168 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 264 | -1.498 mg/dL | Standard Deviation 2.379 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 144 | -1.609 mg/dL | Standard Deviation 2.297 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 2 | -0.752 mg/dL | Standard Deviation 1.724 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 252 | -1.488 mg/dL | Standard Deviation 2.263 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 156 | -1.423 mg/dL | Standard Deviation 2.489 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 372 | -2.330 mg/dL | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 240 | -1.440 mg/dL | Standard Deviation 2.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 168 | -1.576 mg/dL | Standard Deviation 2.213 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 28 | -1.376 mg/dL | Standard Deviation 2.039 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 228 | -1.449 mg/dL | Standard Deviation 2.232 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 180 | -1.170 mg/dL | Standard Deviation 2.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 32 | -1.296 mg/dL | Standard Deviation 2.04 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 216 | -1.374 mg/dL | Standard Deviation 2.209 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 192 | -1.506 mg/dL | Standard Deviation 1.976 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 36 | -1.330 mg/dL | Standard Deviation 2.073 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 204 | -1.477 mg/dL | Standard Deviation 2.154 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 4 | -0.745 mg/dL | Standard Deviation 1.897 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 360 | -2.179 mg/dL | Standard Deviation 2.117 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 40 | -1.361 mg/dL | Standard Deviation 2.217 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 44 | -1.361 mg/dL | Standard Deviation 2.26 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 48 | -1.367 mg/dL | Standard Deviation 2.07 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 8 | -1.032 mg/dL | Standard Deviation 1.932 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 348 | -1.365 mg/dL | Standard Deviation 2.015 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 60 | -1.310 mg/dL | Standard Deviation 2.011 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 12 | -1.034 mg/dL | Standard Deviation 2.225 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 336 | -1.452 mg/dL | Standard Deviation 2.189 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 72 | -1.456 mg/dL | Standard Deviation 2.165 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | EOS | -0.967 mg/dL | Standard Deviation 2.251 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 324 | -1.565 mg/dL | Standard Deviation 2.238 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 84 | -1.418 mg/dL | Standard Deviation 2.159 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 0 | -0.334 mg/dL | Standard Deviation 1.691 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 312 | -1.263 mg/dL | Standard Deviation 2.319 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 96 | -1.485 mg/dL | Standard Deviation 2.113 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | EOT | -1.072 mg/dL | Standard Deviation 2.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 300 | -1.537 mg/dL | Standard Deviation 2.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 108 | -1.562 mg/dL | Standard Deviation 2.06 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 16 | -1.176 mg/dL | Standard Deviation 2.203 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 288 | -1.580 mg/dL | Standard Deviation 2.404 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 120 | -1.507 mg/dL | Standard Deviation 2.199 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 20 | -1.242 mg/dL | Standard Deviation 2.221 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 276 | -1.647 mg/dL | Standard Deviation 2.264 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 132 | -1.443 mg/dL | Standard Deviation 2.602 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 84 | -1.501 mg/dL | Standard Deviation 2.337 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 0 | -1.590 mg/dL | Standard Deviation 2.106 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 12 | -1.528 mg/dL | Standard Deviation 2.121 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 24 | -1.507 mg/dL | Standard Deviation 2.129 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 36 | -1.552 mg/dL | Standard Deviation 2.087 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 48 | -1.604 mg/dL | Standard Deviation 2.096 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 60 | -1.534 mg/dL | Standard Deviation 2.163 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 72 | -1.726 mg/dL | Standard Deviation 2.008 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 96 | -1.561 mg/dL | Standard Deviation 2.101 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 108 | -1.565 mg/dL | Standard Deviation 2.444 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 120 | -1.730 mg/dL | Standard Deviation 2.163 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 132 | -1.519 mg/dL | Standard Deviation 2.231 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 144 | -1.474 mg/dL | Standard Deviation 2.155 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 156 | -1.731 mg/dL | Standard Deviation 1.892 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 168 | -1.418 mg/dL | Standard Deviation 2.153 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 180 | -2.088 mg/dL | Standard Deviation 1.984 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 192 | -1.501 mg/dL | Standard Deviation 1.575 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 204 | -1.570 mg/dL | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | EOT | -1.386 mg/dL | Standard Deviation 2.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | EOS | -1.262 mg/dL | Standard Deviation 2.93 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 180 | -2.230 mg/dL | Standard Deviation 2.053 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 168 | -2.211 mg/dL | Standard Deviation 2.227 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 156 | -2.432 mg/dL | Standard Deviation 2.277 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 144 | -2.120 mg/dL | Standard Deviation 2.329 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 132 | -2.058 mg/dL | Standard Deviation 2.178 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 120 | -1.964 mg/dL | Standard Deviation 2.108 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 108 | -2.066 mg/dL | Standard Deviation 1.99 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 96 | -1.983 mg/dL | Standard Deviation 2.606 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 84 | -1.991 mg/dL | Standard Deviation 2.092 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 72 | -2.019 mg/dL | Standard Deviation 2.023 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 60 | -2.063 mg/dL | Standard Deviation 2.062 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 48 | -2.088 mg/dL | Standard Deviation 2.034 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 36 | -2.031 mg/dL | Standard Deviation 2.116 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 24 | -1.991 mg/dL | Standard Deviation 2.125 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 12 | -1.932 mg/dL | Standard Deviation 2.037 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | EOS | -1.270 mg/dL | Standard Deviation 2.818 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | EOT | -1.845 mg/dL | Standard Deviation 2.438 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 192 | -2.060 mg/dL | Standard Deviation 2.014 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 0 | -1.932 mg/dL | Standard Deviation 2.014 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372 | Week 204 | -0.950 mg/dL | — |
Secondary
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 84 | -2.41 units on a scale | Standard Deviation 1.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 264 | -2.75 units on a scale | Standard Deviation 1.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 144 | -2.67 units on a scale | Standard Deviation 1.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 372 | -4.63 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 252 | -2.75 units on a scale | Standard Deviation 1.42 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 156 | -2.59 units on a scale | Standard Deviation 1.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 16 | -1.76 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 240 | -2.77 units on a scale | Standard Deviation 1.36 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 168 | -2.61 units on a scale | Standard Deviation 1.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 20 | -1.85 units on a scale | Standard Deviation 1.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 228 | -2.75 units on a scale | Standard Deviation 1.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 180 | -2.57 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 24 | -1.92 units on a scale | Standard Deviation 1.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 216 | -2.70 units on a scale | Standard Deviation 1.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 192 | -2.70 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 0 | -0.71 units on a scale | Standard Deviation 1.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 204 | -2.76 units on a scale | Standard Deviation 1.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 360 | -3.28 units on a scale | Standard Deviation 1.06 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 28 | -2.03 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 32 | -1.97 units on a scale | Standard Deviation 1.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 36 | -2.08 units on a scale | Standard Deviation 1.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | EOT | -1.59 units on a scale | Standard Deviation 1.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 348 | -2.53 units on a scale | Standard Deviation 1.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 40 | -2.12 units on a scale | Standard Deviation 1.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 44 | -2.24 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 48 | -2.22 units on a scale | Standard Deviation 1.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | EOS | -2.14 units on a scale | Standard Deviation 1.57 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 336 | -2.65 units on a scale | Standard Deviation 1.23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 60 | -2.25 units on a scale | Standard Deviation 1.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 2 | -1.04 units on a scale | Standard Deviation 1.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 324 | -2.89 units on a scale | Standard Deviation 1.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 72 | -2.35 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 312 | -2.79 units on a scale | Standard Deviation 1.36 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 96 | -2.49 units on a scale | Standard Deviation 1.24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 4 | -1.09 units on a scale | Standard Deviation 1.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 300 | -2.81 units on a scale | Standard Deviation 1.42 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 108 | -2.57 units on a scale | Standard Deviation 1.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 8 | -1.41 units on a scale | Standard Deviation 1.13 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 288 | -2.81 units on a scale | Standard Deviation 1.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 120 | -2.51 units on a scale | Standard Deviation 1.33 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 12 | -1.61 units on a scale | Standard Deviation 1.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 276 | -2.86 units on a scale | Standard Deviation 1.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 132 | -2.58 units on a scale | Standard Deviation 1.39 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 84 | -2.77 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 72 | -2.88 units on a scale | Standard Deviation 1.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 0 | -2.67 units on a scale | Standard Deviation 1.32 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 12 | -2.64 units on a scale | Standard Deviation 1.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 24 | -2.66 units on a scale | Standard Deviation 1.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 36 | -2.79 units on a scale | Standard Deviation 1.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 48 | -2.77 units on a scale | Standard Deviation 1.31 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 60 | -2.71 units on a scale | Standard Deviation 1.37 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 96 | -2.82 units on a scale | Standard Deviation 1.35 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 108 | -2.88 units on a scale | Standard Deviation 1.41 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 120 | -3.02 units on a scale | Standard Deviation 1.33 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 132 | -2.98 units on a scale | Standard Deviation 1.48 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 144 | -2.96 units on a scale | Standard Deviation 1.49 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 156 | -3.15 units on a scale | Standard Deviation 1.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 168 | -3.06 units on a scale | Standard Deviation 1.58 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 180 | -3.14 units on a scale | Standard Deviation 1.52 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 192 | -3.14 units on a scale | Standard Deviation 1.51 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 204 | -3.52 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | EOS | -2.67 units on a scale | Standard Deviation 1.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | EOT | -2.01 units on a scale | Standard Deviation 1.41 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 180 | -3.34 units on a scale | Standard Deviation 1.21 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 168 | -3.16 units on a scale | Standard Deviation 1.25 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 156 | -3.25 units on a scale | Standard Deviation 1.25 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 144 | -3.12 units on a scale | Standard Deviation 1.28 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 132 | -3.19 units on a scale | Standard Deviation 1.14 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 120 | -3.17 units on a scale | Standard Deviation 1.18 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 108 | -3.22 units on a scale | Standard Deviation 1.13 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 96 | -3.16 units on a scale | Standard Deviation 1.11 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 84 | -3.12 units on a scale | Standard Deviation 1.18 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 60 | -3.06 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 48 | -3.08 units on a scale | Standard Deviation 1.17 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 36 | -3.01 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 24 | -2.93 units on a scale | Standard Deviation 1.2 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 12 | -2.82 units on a scale | Standard Deviation 1.26 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 0 | -2.79 units on a scale | Standard Deviation 1.23 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | EOT | -2.13 units on a scale | Standard Deviation 1.45 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | EOS | -3.05 units on a scale | Standard Deviation 1.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 192 | -3.14 units on a scale | Standard Deviation 1.27 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 72 | -3.13 units on a scale | Standard Deviation 1.16 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in DAS28-CRP Through Week 372 | Week 204 | -4.01 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Higher ESR indicates greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 132 | -19.43 mm/h | Standard Deviation 23.78 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 24 | -14.45 mm/h | Standard Deviation 18.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 252 | -20.78 mm/h | Standard Deviation 21.72 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 144 | -22.19 mm/h | Standard Deviation 22.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | EOS | -8.90 mm/h | Standard Deviation 24.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 240 | -19.24 mm/h | Standard Deviation 22.01 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 156 | -20.62 mm/h | Standard Deviation 23.11 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 372 | -28.00 mm/h | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 228 | -20.09 mm/h | Standard Deviation 22.96 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 168 | -20.58 mm/h | Standard Deviation 22.98 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 28 | -15.15 mm/h | Standard Deviation 17.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 216 | -17.85 mm/h | Standard Deviation 23.11 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 180 | -16.28 mm/h | Standard Deviation 23.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 32 | -16.20 mm/h | Standard Deviation 17.74 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 324 | -17.28 mm/h | Standard Deviation 22.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 192 | -18.86 mm/h | Standard Deviation 20.85 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 36 | -16.26 mm/h | Standard Deviation 19.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 204 | -19.05 mm/h | Standard Deviation 21.63 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 2 | -6.65 mm/h | Standard Deviation 18.03 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 360 | -20.63 mm/h | Standard Deviation 22.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 40 | -16.27 mm/h | Standard Deviation 19.89 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 44 | -15.60 mm/h | Standard Deviation 20.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 48 | -16.09 mm/h | Standard Deviation 19.14 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 4 | -6.93 mm/h | Standard Deviation 18.01 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 348 | -16.53 mm/h | Standard Deviation 21.63 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 60 | -16.71 mm/h | Standard Deviation 19.07 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 8 | -10.54 mm/h | Standard Deviation 17.93 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 336 | -17.51 mm/h | Standard Deviation 21.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 72 | -16.78 mm/h | Standard Deviation 21.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 12 | -11.93 mm/h | Standard Deviation 18.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 312 | -16.81 mm/h | Standard Deviation 21.06 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 84 | -16.89 mm/h | Standard Deviation 20.87 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 0 | -2.46 mm/h | Standard Deviation 17.83 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 300 | -19.51 mm/h | Standard Deviation 20.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 96 | -18.81 mm/h | Standard Deviation 21.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | EOT | -12.52 mm/h | Standard Deviation 21.92 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 288 | -17.57 mm/h | Standard Deviation 25.36 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 108 | -19.24 mm/h | Standard Deviation 20.02 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 16 | -13.39 mm/h | Standard Deviation 19.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 276 | -20.21 mm/h | Standard Deviation 21.14 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 120 | -19.48 mm/h | Standard Deviation 21.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 20 | -14.07 mm/h | Standard Deviation 17.92 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 264 | -19.11 mm/h | Standard Deviation 24.2 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 204 | -11.00 mm/h | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 0 | -22.66 mm/h | Standard Deviation 25.31 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 12 | -22.43 mm/h | Standard Deviation 26.18 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 24 | -22.91 mm/h | Standard Deviation 25.13 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 36 | -22.51 mm/h | Standard Deviation 26.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 48 | -23.63 mm/h | Standard Deviation 25.51 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 60 | -23.34 mm/h | Standard Deviation 24.86 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 72 | -24.70 mm/h | Standard Deviation 24.16 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 84 | -22.58 mm/h | Standard Deviation 26.95 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 96 | -21.71 mm/h | Standard Deviation 25.55 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 108 | -22.46 mm/h | Standard Deviation 25.87 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 120 | -24.36 mm/h | Standard Deviation 25.63 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 132 | -22.13 mm/h | Standard Deviation 26.42 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 144 | -21.48 mm/h | Standard Deviation 22.87 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 156 | -23.14 mm/h | Standard Deviation 23.91 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 168 | -24.95 mm/h | Standard Deviation 22.89 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 180 | -23.52 mm/h | Standard Deviation 28.44 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 192 | -38.63 mm/h | Standard Deviation 35.76 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | EOT | -20.04 mm/h | Standard Deviation 26.47 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | EOS | -14.48 mm/h | Standard Deviation 25.73 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 204 | -57.00 mm/h | — |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 168 | -29.68 mm/h | Standard Deviation 22.86 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 156 | -30.77 mm/h | Standard Deviation 25.02 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 144 | -31.44 mm/h | Standard Deviation 24.17 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 132 | -30.35 mm/h | Standard Deviation 24.34 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 120 | -29.46 mm/h | Standard Deviation 25.87 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 108 | -29.97 mm/h | Standard Deviation 25.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 96 | -29.70 mm/h | Standard Deviation 25.14 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 84 | -29.23 mm/h | Standard Deviation 24.23 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 72 | -30.06 mm/h | Standard Deviation 23.85 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 60 | -30.06 mm/h | Standard Deviation 23.69 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 48 | -30.31 mm/h | Standard Deviation 23.67 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 36 | -29.41 mm/h | Standard Deviation 23.34 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 24 | -28.54 mm/h | Standard Deviation 24.45 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 12 | -27.72 mm/h | Standard Deviation 23.47 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | EOS | -17.26 mm/h | Standard Deviation 27.2 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | EOT | -26.36 mm/h | Standard Deviation 27 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 0 | -27.02 mm/h | Standard Deviation 23.11 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 192 | -26.50 mm/h | Standard Deviation 27.72 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372 | Week 180 | -33.46 mm/h | Standard Deviation 24.7 |
Secondary
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOS
Population: FAS population with available data at each time point. Only 015K-CL-RAJ1 arm was analyzed for this outcome as planned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 0 | 1.71 units on a scale | Standard Deviation 8.52 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 2 | 4.50 units on a scale | Standard Deviation 3.54 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 4 | 3.29 units on a scale | Standard Deviation 8.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 8 | 4.15 units on a scale | Standard Deviation 8.66 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 12 | 4.85 units on a scale | Standard Deviation 8.79 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 16 | 5.91 units on a scale | Standard Deviation 8.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 20 | 5.86 units on a scale | Standard Deviation 9.26 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 24 | 5.99 units on a scale | Standard Deviation 8.93 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 28 | 5.95 units on a scale | Standard Deviation 8.96 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 32 | 5.91 units on a scale | Standard Deviation 8.49 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 36 | 5.91 units on a scale | Standard Deviation 8.72 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 40 | 6.06 units on a scale | Standard Deviation 8.87 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 44 | 6.05 units on a scale | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 48 | 6.34 units on a scale | Standard Deviation 8.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 60 | 7.18 units on a scale | Standard Deviation 9.03 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 72 | 5.87 units on a scale | Standard Deviation 8.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 84 | 6.11 units on a scale | Standard Deviation 8.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 96 | 6.10 units on a scale | Standard Deviation 8.22 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | Week 108 | -6.0 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | EOT | 5.95 units on a scale | Standard Deviation 9.24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108 | EOS | 3.67 units on a scale | Standard Deviation 9.77 |
Secondary
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 264 | -0.32 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 132 | -0.31 units on a scale | Standard Deviation 0.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 372 | -0.88 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 252 | -0.35 units on a scale | Standard Deviation 0.55 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 144 | -0.33 units on a scale | Standard Deviation 0.51 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 16 | -0.21 units on a scale | Standard Deviation 0.45 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 20 | -0.22 units on a scale | Standard Deviation 0.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 240 | -0.31 units on a scale | Standard Deviation 0.61 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 168 | -0.31 units on a scale | Standard Deviation 0.53 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 24 | -0.25 units on a scale | Standard Deviation 0.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 228 | -0.34 units on a scale | Standard Deviation 0.58 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 180 | -0.32 units on a scale | Standard Deviation 0.56 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 0 | -0.03 units on a scale | Standard Deviation 0.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 216 | -0.35 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 192 | -0.32 units on a scale | Standard Deviation 0.53 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 360 | -0.41 units on a scale | Standard Deviation 0.58 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 204 | -0.32 units on a scale | Standard Deviation 0.53 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 28 | -0.27 units on a scale | Standard Deviation 0.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 32 | -0.27 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 36 | -0.25 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 108 | -0.30 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 348 | -0.29 units on a scale | Standard Deviation 0.62 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 40 | -0.25 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 44 | -0.26 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 48 | -0.27 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | EOS | -0.08 units on a scale | Standard Deviation 0.63 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 336 | -0.31 units on a scale | Standard Deviation 0.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 60 | -0.28 units on a scale | Standard Deviation 0.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | EOT | -0.22 units on a scale | Standard Deviation 0.62 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 324 | -0.35 units on a scale | Standard Deviation 0.54 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 72 | -0.29 units on a scale | Standard Deviation 0.51 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 2 | -0.07 units on a scale | Standard Deviation 0.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 312 | -0.37 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 84 | -0.29 units on a scale | Standard Deviation 0.51 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 4 | -0.08 units on a scale | Standard Deviation 0.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 300 | -0.35 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 96 | -0.29 units on a scale | Standard Deviation 0.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 8 | -0.13 units on a scale | Standard Deviation 0.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 288 | -0.34 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 12 | -0.17 units on a scale | Standard Deviation 0.45 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 276 | -0.36 units on a scale | Standard Deviation 0.56 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 120 | -0.30 units on a scale | Standard Deviation 0.49 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 156 | -0.33 units on a scale | Standard Deviation 0.53 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 36 | -0.43 units on a scale | Standard Deviation 0.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 0 | -0.43 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 12 | -0.44 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 24 | -0.43 units on a scale | Standard Deviation 0.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 48 | -0.42 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 60 | -0.43 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 72 | -0.44 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 84 | -0.45 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 96 | -0.42 units on a scale | Standard Deviation 0.61 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 108 | -0.40 units on a scale | Standard Deviation 0.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 120 | -0.48 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 132 | -0.49 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 144 | -0.49 units on a scale | Standard Deviation 0.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 156 | -0.52 units on a scale | Standard Deviation 0.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 168 | -0.41 units on a scale | Standard Deviation 0.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 180 | -0.29 units on a scale | Standard Deviation 0.69 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 192 | -0.25 units on a scale | Standard Deviation 0.68 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 204 | -0.75 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | EOT | -0.37 units on a scale | Standard Deviation 0.63 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | EOS | -0.17 units on a scale | Standard Deviation 0.62 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 180 | -0.52 units on a scale | Standard Deviation 0.48 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 168 | -0.51 units on a scale | Standard Deviation 0.5 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 156 | -0.58 units on a scale | Standard Deviation 0.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 132 | -0.60 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 120 | -0.60 units on a scale | Standard Deviation 0.58 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 108 | -0.60 units on a scale | Standard Deviation 0.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 96 | -0.59 units on a scale | Standard Deviation 0.58 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 84 | -0.56 units on a scale | Standard Deviation 0.57 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 72 | -0.56 units on a scale | Standard Deviation 0.58 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 60 | -0.55 units on a scale | Standard Deviation 0.56 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 48 | -0.55 units on a scale | Standard Deviation 0.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 36 | -0.52 units on a scale | Standard Deviation 0.56 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 24 | -0.52 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 12 | -0.48 units on a scale | Standard Deviation 0.59 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 0 | -0.49 units on a scale | Standard Deviation 0.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | EOS | -0.28 units on a scale | Standard Deviation 0.73 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | EOT | -0.51 units on a scale | Standard Deviation 0.62 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 192 | -0.44 units on a scale | Standard Deviation 0.58 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 144 | -0.58 units on a scale | Standard Deviation 0.53 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in HAQ-DI Through Week 372 | Week 204 | -0.75 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 24 | -27.56 units on a scale | Standard Deviation 23.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 264 | -41.13 units on a scale | Standard Deviation 24.71 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 144 | -39.11 units on a scale | Standard Deviation 24.31 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 2 | -13.48 units on a scale | Standard Deviation 20.82 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 252 | -41.55 units on a scale | Standard Deviation 23.74 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 156 | -37.72 units on a scale | Standard Deviation 24.91 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 372 | -47.00 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 240 | -41.67 units on a scale | Standard Deviation 24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 168 | -39.55 units on a scale | Standard Deviation 24.87 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 28 | -29.22 units on a scale | Standard Deviation 24.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 228 | -40.08 units on a scale | Standard Deviation 23.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 180 | -37.34 units on a scale | Standard Deviation 25.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 32 | -27.80 units on a scale | Standard Deviation 24.05 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 216 | -40.80 units on a scale | Standard Deviation 23.52 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 192 | -39.13 units on a scale | Standard Deviation 24.79 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 36 | -29.94 units on a scale | Standard Deviation 22.82 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 204 | -40.46 units on a scale | Standard Deviation 22.73 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 4 | -16.78 units on a scale | Standard Deviation 21.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 360 | -40.25 units on a scale | Standard Deviation 18.36 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 40 | -31.58 units on a scale | Standard Deviation 21.55 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 44 | -31.60 units on a scale | Standard Deviation 22.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 48 | -33.04 units on a scale | Standard Deviation 23.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 8 | -20.59 units on a scale | Standard Deviation 23.69 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 348 | -38.71 units on a scale | Standard Deviation 24.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 60 | -32.82 units on a scale | Standard Deviation 24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 12 | -24.33 units on a scale | Standard Deviation 23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 336 | -39.55 units on a scale | Standard Deviation 25.31 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 72 | -33.68 units on a scale | Standard Deviation 24.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | EOS | -20.31 units on a scale | Standard Deviation 26.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 324 | -42.73 units on a scale | Standard Deviation 22.93 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 84 | -33.39 units on a scale | Standard Deviation 25.87 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 0 | -10.77 units on a scale | Standard Deviation 21.64 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 312 | -42.18 units on a scale | Standard Deviation 22.71 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 96 | -34.12 units on a scale | Standard Deviation 23.79 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | EOT | -30.72 units on a scale | Standard Deviation 27.55 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 300 | -41.40 units on a scale | Standard Deviation 22.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 108 | -35.70 units on a scale | Standard Deviation 24.63 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 16 | -26.64 units on a scale | Standard Deviation 22.86 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 288 | -42.21 units on a scale | Standard Deviation 25.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 120 | -35.14 units on a scale | Standard Deviation 25.13 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 20 | -27.12 units on a scale | Standard Deviation 23.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 276 | -42.46 units on a scale | Standard Deviation 22.75 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 132 | -37.24 units on a scale | Standard Deviation 25.9 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 84 | -41.31 units on a scale | Standard Deviation 25.12 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 0 | -41.57 units on a scale | Standard Deviation 22.92 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 12 | -40.22 units on a scale | Standard Deviation 23.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 24 | -40.65 units on a scale | Standard Deviation 24.02 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 36 | -41.60 units on a scale | Standard Deviation 24.88 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 48 | -41.92 units on a scale | Standard Deviation 23.36 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 60 | -41.84 units on a scale | Standard Deviation 23.31 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 72 | -42.48 units on a scale | Standard Deviation 22.83 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 96 | -43.26 units on a scale | Standard Deviation 24.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 108 | -43.55 units on a scale | Standard Deviation 23.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 120 | -45.11 units on a scale | Standard Deviation 23.65 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 132 | -45.51 units on a scale | Standard Deviation 24.94 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 144 | -45.70 units on a scale | Standard Deviation 27.19 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 156 | -48.04 units on a scale | Standard Deviation 25.43 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 168 | -45.54 units on a scale | Standard Deviation 24.77 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 180 | -44.62 units on a scale | Standard Deviation 29 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 192 | -33.75 units on a scale | Standard Deviation 36.86 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 204 | -30.00 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | EOT | -39.86 units on a scale | Standard Deviation 26.19 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | EOS | -30.01 units on a scale | Standard Deviation 25.67 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 180 | -46.01 units on a scale | Standard Deviation 20.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 168 | -45.07 units on a scale | Standard Deviation 22.38 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 156 | -46.65 units on a scale | Standard Deviation 21.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 144 | -45.85 units on a scale | Standard Deviation 22.35 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 132 | -47.50 units on a scale | Standard Deviation 20.77 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 120 | -46.99 units on a scale | Standard Deviation 22.76 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 108 | -48.04 units on a scale | Standard Deviation 22.43 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 96 | -47.35 units on a scale | Standard Deviation 21.98 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 84 | -46.42 units on a scale | Standard Deviation 22.33 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 72 | -47.05 units on a scale | Standard Deviation 21.35 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 60 | -45.20 units on a scale | Standard Deviation 22 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 48 | -45.71 units on a scale | Standard Deviation 21.52 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 36 | -44.81 units on a scale | Standard Deviation 21.41 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 24 | -43.81 units on a scale | Standard Deviation 23.23 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 12 | -42.77 units on a scale | Standard Deviation 23.09 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | EOS | -36.11 units on a scale | Standard Deviation 27.05 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | EOT | -45.04 units on a scale | Standard Deviation 24.76 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 192 | -44.50 units on a scale | Standard Deviation 19.39 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 0 | -43.09 units on a scale | Standard Deviation 23.21 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372 | Week 204 | -53.50 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in SDAI Score Through Week 372
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 24 | -18.61 units on a scale | Standard Deviation 11.99 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 264 | -24.36 units on a scale | Standard Deviation 13.22 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 144 | -23.58 units on a scale | Standard Deviation 12.96 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 2 | -10.13 units on a scale | Standard Deviation 11.06 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 252 | -24.47 units on a scale | Standard Deviation 13.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 156 | -23.19 units on a scale | Standard Deviation 13.04 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 372 | -53.18 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 240 | -24.55 units on a scale | Standard Deviation 12.88 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 168 | -23.64 units on a scale | Standard Deviation 13.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 28 | -19.43 units on a scale | Standard Deviation 12.07 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 228 | -24.18 units on a scale | Standard Deviation 12.64 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 180 | -23.07 units on a scale | Standard Deviation 13.37 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 32 | -18.66 units on a scale | Standard Deviation 12.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 216 | -24.00 units on a scale | Standard Deviation 12.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 192 | -23.75 units on a scale | Standard Deviation 13.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 36 | -19.62 units on a scale | Standard Deviation 11.23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 204 | -24.42 units on a scale | Standard Deviation 12.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 4 | -10.93 units on a scale | Standard Deviation 12.01 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 360 | -27.23 units on a scale | Standard Deviation 11.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 40 | -20.26 units on a scale | Standard Deviation 11.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 44 | -20.96 units on a scale | Standard Deviation 11.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 48 | -21.17 units on a scale | Standard Deviation 11.97 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 8 | -14.33 units on a scale | Standard Deviation 12.03 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 348 | -22.45 units on a scale | Standard Deviation 11.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 60 | -21.10 units on a scale | Standard Deviation 12.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 12 | -16.14 units on a scale | Standard Deviation 12.02 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 336 | -23.68 units on a scale | Standard Deviation 12.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 72 | -21.65 units on a scale | Standard Deviation 13.09 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | EOS | -14.81 units on a scale | Standard Deviation 13.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 324 | -25.45 units on a scale | Standard Deviation 12.83 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 84 | -21.82 units on a scale | Standard Deviation 12.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 0 | -7.41 units on a scale | Standard Deviation 11.53 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 312 | -24.52 units on a scale | Standard Deviation 13.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 96 | -22.40 units on a scale | Standard Deviation 12.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | EOT | -19.12 units on a scale | Standard Deviation 15.01 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 300 | -24.56 units on a scale | Standard Deviation 13.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 108 | -22.73 units on a scale | Standard Deviation 12.74 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 16 | -17.53 units on a scale | Standard Deviation 11.95 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 288 | -24.71 units on a scale | Standard Deviation 13.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 120 | -22.18 units on a scale | Standard Deviation 13.61 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 20 | -18.11 units on a scale | Standard Deviation 12.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 276 | -25.23 units on a scale | Standard Deviation 12.77 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 132 | -22.90 units on a scale | Standard Deviation 13.51 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 84 | -24.70 units on a scale | Standard Deviation 13.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 0 | -24.30 units on a scale | Standard Deviation 13.03 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 12 | -23.93 units on a scale | Standard Deviation 13.02 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 24 | -24.13 units on a scale | Standard Deviation 12.84 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 36 | -25.00 units on a scale | Standard Deviation 13.12 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 48 | -24.93 units on a scale | Standard Deviation 12.56 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 60 | -24.54 units on a scale | Standard Deviation 13.27 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 72 | -25.17 units on a scale | Standard Deviation 13.02 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 96 | -25.37 units on a scale | Standard Deviation 13.36 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 108 | -25.38 units on a scale | Standard Deviation 13.68 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 120 | -26.57 units on a scale | Standard Deviation 13.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 132 | -26.38 units on a scale | Standard Deviation 14.24 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 144 | -26.53 units on a scale | Standard Deviation 14.75 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 156 | -28.68 units on a scale | Standard Deviation 15.05 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 168 | -26.75 units on a scale | Standard Deviation 15.71 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 180 | -26.63 units on a scale | Standard Deviation 15.13 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 192 | -24.37 units on a scale | Standard Deviation 15.48 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 204 | -26.92 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | EOT | -23.68 units on a scale | Standard Deviation 14.37 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | EOS | -19.25 units on a scale | Standard Deviation 14.64 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 180 | -29.04 units on a scale | Standard Deviation 13.67 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 168 | -27.34 units on a scale | Standard Deviation 13.31 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 156 | -28.07 units on a scale | Standard Deviation 13.27 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 144 | -27.38 units on a scale | Standard Deviation 13.05 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 132 | -27.83 units on a scale | Standard Deviation 12.16 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 120 | -27.71 units on a scale | Standard Deviation 12.37 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 108 | -28.28 units on a scale | Standard Deviation 12.38 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 96 | -27.52 units on a scale | Standard Deviation 11.72 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 84 | -27.15 units on a scale | Standard Deviation 12.02 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 72 | -27.31 units on a scale | Standard Deviation 12.04 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 60 | -26.73 units on a scale | Standard Deviation 12.04 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 48 | -26.75 units on a scale | Standard Deviation 11.98 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 36 | -26.45 units on a scale | Standard Deviation 11.7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 24 | -25.93 units on a scale | Standard Deviation 11.9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 12 | -25.15 units on a scale | Standard Deviation 12.17 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | EOS | -20.05 units on a scale | Standard Deviation 14.05 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | EOT | -26.58 units on a scale | Standard Deviation 13.07 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 192 | -27.99 units on a scale | Standard Deviation 13.04 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 0 | -25.12 units on a scale | Standard Deviation 12.32 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SDAI Score Through Week 372 | Week 204 | -36.00 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 156 | 2.17 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 20 | 4.97 units on a scale | Standard Deviation 9.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 44 | 5.79 units on a scale | Standard Deviation 9.33 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 48 | 5.52 units on a scale | Standard Deviation 9.24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 60 | 5.27 units on a scale | Standard Deviation 9.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 72 | 5.28 units on a scale | Standard Deviation 8.83 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 84 | 5.58 units on a scale | Standard Deviation 9.06 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 96 | 5.42 units on a scale | Standard Deviation 9.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 108 | 3.89 units on a scale | Standard Deviation 7.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 120 | 4.64 units on a scale | Standard Deviation 8.73 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 132 | -2.52 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 144 | 4.38 units on a scale | Standard Deviation 9.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 12 | 4.72 units on a scale | Standard Deviation 9.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 168 | 4.09 units on a scale | Standard Deviation 9.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 192 | 3.56 units on a scale | Standard Deviation 8.52 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | EOT | 3.63 units on a scale | Standard Deviation 9.97 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 216 | 2.95 units on a scale | Standard Deviation 9.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 240 | 3.45 units on a scale | Standard Deviation 9.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 276 | 6.20 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 288 | 3.72 units on a scale | Standard Deviation 9.09 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 300 | 11.12 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 312 | 4.62 units on a scale | Standard Deviation 10.58 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 264 | 4.03 units on a scale | Standard Deviation 9.69 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 324 | 7.83 units on a scale | Standard Deviation 10.42 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 336 | 3.78 units on a scale | Standard Deviation 8.57 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 348 | 2.80 units on a scale | Standard Deviation 6.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 360 | 5.15 units on a scale | Standard Deviation 9.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 372 | -3.24 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 0 | 3.00 units on a scale | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 4 | 3.88 units on a scale | Standard Deviation 8.86 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 8 | 3.85 units on a scale | Standard Deviation 9.51 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 16 | 4.61 units on a scale | Standard Deviation 9.25 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 24 | 6.01 units on a scale | Standard Deviation 9.13 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 28 | 5.38 units on a scale | Standard Deviation 9.74 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 32 | 5.13 units on a scale | Standard Deviation 9.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 36 | 5.18 units on a scale | Standard Deviation 9.05 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 40 | 5.70 units on a scale | Standard Deviation 9.27 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 72 | 2.87 units on a scale | Standard Deviation 9.31 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 120 | 2.40 units on a scale | Standard Deviation 8.67 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 48 | 1.74 units on a scale | Standard Deviation 8.78 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | EOT | 1.54 units on a scale | Standard Deviation 9.91 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 144 | 1.56 units on a scale | Standard Deviation 9.22 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 0 | 2.94 units on a scale | Standard Deviation 8.52 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 192 | 2.23 units on a scale | Standard Deviation 3.58 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 96 | 2.10 units on a scale | Standard Deviation 8.98 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 24 | 2.02 units on a scale | Standard Deviation 9.15 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 168 | 2.41 units on a scale | Standard Deviation 8.92 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 0 | 2.69 units on a scale | Standard Deviation 8.67 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 72 | 2.80 units on a scale | Standard Deviation 8.94 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | EOT | 2.16 units on a scale | Standard Deviation 9.29 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 120 | 1.62 units on a scale | Standard Deviation 9.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 168 | 2.04 units on a scale | Standard Deviation 8.41 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 144 | 1.65 units on a scale | Standard Deviation 8.15 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 48 | 2.89 units on a scale | Standard Deviation 8.76 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 24 | 2.61 units on a scale | Standard Deviation 9.04 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 96 | 2.22 units on a scale | Standard Deviation 9.52 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372 | Week 192 | 2.31 units on a scale | Standard Deviation 6.81 |
Secondary
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 240 | 3.46 units on a scale | Standard Deviation 13.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 276 | 1.82 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 288 | 3.99 units on a scale | Standard Deviation 12.95 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 300 | 12.34 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 312 | 3.87 units on a scale | Standard Deviation 14.89 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 324 | 15.79 units on a scale | Standard Deviation 12.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 336 | 3.54 units on a scale | Standard Deviation 13.56 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 348 | -1.11 units on a scale | Standard Deviation 12.48 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 360 | 1.64 units on a scale | Standard Deviation 12.72 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 372 | -8.61 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | EOT | 2.06 units on a scale | Standard Deviation 14.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 24 | 1.59 units on a scale | Standard Deviation 11.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 28 | 2.68 units on a scale | Standard Deviation 11.73 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 32 | 3.75 units on a scale | Standard Deviation 11.55 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 36 | 1.66 units on a scale | Standard Deviation 12.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 40 | 2.42 units on a scale | Standard Deviation 12.57 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 44 | 1.93 units on a scale | Standard Deviation 12.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 48 | 2.85 units on a scale | Standard Deviation 11.64 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 60 | 3.05 units on a scale | Standard Deviation 12.65 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 72 | 2.56 units on a scale | Standard Deviation 12.84 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 84 | 0.81 units on a scale | Standard Deviation 12.75 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 96 | 2.67 units on a scale | Standard Deviation 12.51 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 108 | -1.62 units on a scale | Standard Deviation 1.64 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 120 | 2.97 units on a scale | Standard Deviation 12.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 132 | -5.25 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 144 | 2.64 units on a scale | Standard Deviation 12.95 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 156 | 5.75 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 168 | 2.88 units on a scale | Standard Deviation 12.83 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 192 | 2.75 units on a scale | Standard Deviation 12.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 216 | 3.50 units on a scale | Standard Deviation 13.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 264 | 2.65 units on a scale | Standard Deviation 13.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 0 | -0.52 units on a scale | Standard Deviation 12.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 4 | 0.29 units on a scale | Standard Deviation 11.16 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 8 | 1.30 units on a scale | Standard Deviation 12.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 12 | 1.70 units on a scale | Standard Deviation 12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 16 | 2.84 units on a scale | Standard Deviation 11.58 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 20 | 2.33 units on a scale | Standard Deviation 12.73 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | EOT | 3.92 units on a scale | Standard Deviation 13.85 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 0 | 5.21 units on a scale | Standard Deviation 13.96 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 168 | 0.50 units on a scale | Standard Deviation 12.86 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 72 | 5.65 units on a scale | Standard Deviation 13.93 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 144 | 5.18 units on a scale | Standard Deviation 14.52 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 24 | 5.06 units on a scale | Standard Deviation 13.55 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 96 | 4.30 units on a scale | Standard Deviation 13.56 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 192 | -0.97 units on a scale | Standard Deviation 12.36 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 120 | 4.55 units on a scale | Standard Deviation 14.28 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 48 | 5.06 units on a scale | Standard Deviation 14.54 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 144 | 5.43 units on a scale | Standard Deviation 15.59 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | EOT | 4.74 units on a scale | Standard Deviation 16.31 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 48 | 5.80 units on a scale | Standard Deviation 15.27 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 192 | 2.17 units on a scale | Standard Deviation 15.2 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 0 | 5.45 units on a scale | Standard Deviation 15.4 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 24 | 5.56 units on a scale | Standard Deviation 15.36 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 168 | 4.11 units on a scale | Standard Deviation 14.33 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 120 | 5.92 units on a scale | Standard Deviation 16.32 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 72 | 6.37 units on a scale | Standard Deviation 15.33 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372 | Week 96 | 5.80 units on a scale | Standard Deviation 15.61 |
Secondary
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 60 | 5.89 units on a scale | Standard Deviation 13.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 72 | 4.94 units on a scale | Standard Deviation 14.02 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 132 | -7.23 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 12 | 2.52 units on a scale | Standard Deviation 13.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 0 | -0.55 units on a scale | Standard Deviation 13.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 144 | 6.94 units on a scale | Standard Deviation 14.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 8 | 1.53 units on a scale | Standard Deviation 12.85 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 4 | 0.30 units on a scale | Standard Deviation 13.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 108 | 0.27 units on a scale | Standard Deviation 14.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 96 | 5.02 units on a scale | Standard Deviation 14.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 156 | -31.60 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 300 | 4.73 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 168 | 6.46 units on a scale | Standard Deviation 15.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 216 | 6.73 units on a scale | Standard Deviation 15.24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 84 | 5.59 units on a scale | Standard Deviation 13.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 24 | 3.56 units on a scale | Standard Deviation 13.69 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 240 | 6.13 units on a scale | Standard Deviation 16.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 264 | 5.97 units on a scale | Standard Deviation 17.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 276 | -22.64 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 288 | 6.21 units on a scale | Standard Deviation 16.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 312 | 6.13 units on a scale | Standard Deviation 16.23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 324 | 21.10 units on a scale | Standard Deviation 23.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 336 | 4.33 units on a scale | Standard Deviation 15.78 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 348 | -5.21 units on a scale | Standard Deviation 13.68 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 360 | 6.92 units on a scale | Standard Deviation 9.75 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 372 | 0.16 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | EOT | 3.44 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 28 | 3.97 units on a scale | Standard Deviation 14.13 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 20 | 3.72 units on a scale | Standard Deviation 14.22 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 32 | 4.14 units on a scale | Standard Deviation 13.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 36 | 3.63 units on a scale | Standard Deviation 14.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 40 | 4.27 units on a scale | Standard Deviation 13.92 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 44 | 4.49 units on a scale | Standard Deviation 13.26 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 48 | 4.51 units on a scale | Standard Deviation 13.42 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 192 | 6.43 units on a scale | Standard Deviation 14.75 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 16 | 4.10 units on a scale | Standard Deviation 13.36 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 120 | 5.01 units on a scale | Standard Deviation 14.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 168 | 9.64 units on a scale | Standard Deviation 12.16 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 120 | 12.59 units on a scale | Standard Deviation 15.29 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 144 | 12.46 units on a scale | Standard Deviation 14.2 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 192 | 10.42 units on a scale | Standard Deviation 16.12 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | EOT | 10.29 units on a scale | Standard Deviation 15.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 48 | 12.31 units on a scale | Standard Deviation 13.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 72 | 12.35 units on a scale | Standard Deviation 14.1 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 0 | 11.62 units on a scale | Standard Deviation 12.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 24 | 12.55 units on a scale | Standard Deviation 13.84 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 96 | 12.15 units on a scale | Standard Deviation 14.95 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 48 | 13.52 units on a scale | Standard Deviation 12.11 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | EOT | 12.62 units on a scale | Standard Deviation 13.23 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 168 | 13.94 units on a scale | Standard Deviation 13.97 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 96 | 14.20 units on a scale | Standard Deviation 13.16 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 24 | 13.23 units on a scale | Standard Deviation 12.43 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 120 | 14.59 units on a scale | Standard Deviation 13.37 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 144 | 14.38 units on a scale | Standard Deviation 13.42 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 192 | 12.60 units on a scale | Standard Deviation 12.95 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 0 | 11.60 units on a scale | Standard Deviation 12.48 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372 | Week 72 | 13.48 units on a scale | Standard Deviation 13.23 |
Secondary
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 24 | -24.41 units on a scale | Standard Deviation 26.68 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 264 | -34.81 units on a scale | Standard Deviation 34.02 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 144 | -33.53 units on a scale | Standard Deviation 31.99 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 2 | -11.21 units on a scale | Standard Deviation 23.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 252 | -34.88 units on a scale | Standard Deviation 33.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 156 | -33.61 units on a scale | Standard Deviation 31.76 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 372 | -58.60 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 240 | -34.98 units on a scale | Standard Deviation 32.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 168 | -34.24 units on a scale | Standard Deviation 32.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 28 | -26.74 units on a scale | Standard Deviation 27.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 228 | -34.44 units on a scale | Standard Deviation 33.92 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 180 | -33.40 units on a scale | Standard Deviation 32.56 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 32 | -27.41 units on a scale | Standard Deviation 28.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 216 | -33.21 units on a scale | Standard Deviation 33.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 192 | -34.50 units on a scale | Standard Deviation 30.26 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 36 | -26.73 units on a scale | Standard Deviation 28.04 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 204 | -35.88 units on a scale | Standard Deviation 30.63 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 4 | -13.10 units on a scale | Standard Deviation 24.45 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 360 | -35.59 units on a scale | Standard Deviation 26.94 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 40 | -28.62 units on a scale | Standard Deviation 28.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 44 | -29.08 units on a scale | Standard Deviation 27.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 48 | -30.08 units on a scale | Standard Deviation 27.09 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 8 | -17.70 units on a scale | Standard Deviation 26.93 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 348 | -25.96 units on a scale | Standard Deviation 33.18 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 60 | -30.88 units on a scale | Standard Deviation 28.64 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 12 | -20.54 units on a scale | Standard Deviation 25.98 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 336 | -32.56 units on a scale | Standard Deviation 32.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 72 | -30.47 units on a scale | Standard Deviation 28.23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | EOS | -19.77 units on a scale | Standard Deviation 28.17 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 324 | -33.43 units on a scale | Standard Deviation 34.58 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 84 | -29.41 units on a scale | Standard Deviation 31.51 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 0 | -7.37 units on a scale | Standard Deviation 25.85 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 312 | -35.42 units on a scale | Standard Deviation 33.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 96 | -31.59 units on a scale | Standard Deviation 31.98 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | EOT | -26.57 units on a scale | Standard Deviation 32.59 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 300 | -35.73 units on a scale | Standard Deviation 34.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 108 | -31.16 units on a scale | Standard Deviation 31.19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 16 | -23.12 units on a scale | Standard Deviation 26.94 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 288 | -34.63 units on a scale | Standard Deviation 33.46 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 120 | -31.92 units on a scale | Standard Deviation 30.85 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 20 | -24.00 units on a scale | Standard Deviation 27.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 276 | -36.12 units on a scale | Standard Deviation 32.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 132 | -32.42 units on a scale | Standard Deviation 31.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 84 | -35.14 units on a scale | Standard Deviation 30.67 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 0 | -36.09 units on a scale | Standard Deviation 30.09 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 12 | -35.75 units on a scale | Standard Deviation 30.36 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 24 | -36.38 units on a scale | Standard Deviation 30.17 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 36 | -36.68 units on a scale | Standard Deviation 30.38 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 48 | -35.88 units on a scale | Standard Deviation 30.24 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 60 | -35.77 units on a scale | Standard Deviation 30.45 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 72 | -36.54 units on a scale | Standard Deviation 29.83 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 96 | -34.55 units on a scale | Standard Deviation 30.47 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 108 | -35.52 units on a scale | Standard Deviation 30.77 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 120 | -38.32 units on a scale | Standard Deviation 29.85 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 132 | -38.30 units on a scale | Standard Deviation 29.75 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 144 | -39.02 units on a scale | Standard Deviation 29.85 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 156 | -40.11 units on a scale | Standard Deviation 29.13 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 168 | -38.27 units on a scale | Standard Deviation 28.57 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 180 | -42.90 units on a scale | Standard Deviation 30.7 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 192 | -50.81 units on a scale | Standard Deviation 36.83 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 204 | -82.50 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | EOT | -33.82 units on a scale | Standard Deviation 32.32 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | EOS | -29.87 units on a scale | Standard Deviation 31.05 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 180 | -37.85 units on a scale | Standard Deviation 25.95 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 168 | -36.96 units on a scale | Standard Deviation 26.23 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 156 | -37.08 units on a scale | Standard Deviation 26.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 144 | -36.34 units on a scale | Standard Deviation 25.75 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 132 | -36.66 units on a scale | Standard Deviation 26.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 120 | -38.34 units on a scale | Standard Deviation 27.88 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 108 | -38.72 units on a scale | Standard Deviation 26.97 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 96 | -37.83 units on a scale | Standard Deviation 27.59 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 84 | -37.58 units on a scale | Standard Deviation 27.07 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 72 | -37.36 units on a scale | Standard Deviation 26.86 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 60 | -36.93 units on a scale | Standard Deviation 27.51 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 48 | -37.16 units on a scale | Standard Deviation 26.89 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 36 | -37.30 units on a scale | Standard Deviation 26.59 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 24 | -36.17 units on a scale | Standard Deviation 27.15 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 12 | -34.27 units on a scale | Standard Deviation 28.19 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | EOS | -21.54 units on a scale | Standard Deviation 30.66 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | EOT | -35.84 units on a scale | Standard Deviation 30.02 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 192 | -40.86 units on a scale | Standard Deviation 28.24 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 0 | -34.79 units on a scale | Standard Deviation 26.98 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372 | Week 204 | -58.00 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | EOT | -26.04 units on a scale | Standard Deviation 31.99 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 264 | -34.57 units on a scale | Standard Deviation 33.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 132 | -32.61 units on a scale | Standard Deviation 31.77 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 16 | -23.45 units on a scale | Standard Deviation 27.01 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 252 | -34.84 units on a scale | Standard Deviation 31.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 144 | -33.67 units on a scale | Standard Deviation 29.23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 20 | -24.35 units on a scale | Standard Deviation 27.63 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 240 | -35.14 units on a scale | Standard Deviation 31.35 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 156 | -34.15 units on a scale | Standard Deviation 30.71 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 24 | -24.78 units on a scale | Standard Deviation 26.98 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 228 | -34.81 units on a scale | Standard Deviation 32.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 168 | -33.59 units on a scale | Standard Deviation 30.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 180 | -33.56 units on a scale | Standard Deviation 30.55 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 216 | -33.69 units on a scale | Standard Deviation 32.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 192 | -34.94 units on a scale | Standard Deviation 29.42 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 372 | -71.50 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 204 | -35.65 units on a scale | Standard Deviation 29.79 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 28 | -27.29 units on a scale | Standard Deviation 27.34 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 32 | -27.78 units on a scale | Standard Deviation 28.04 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 36 | -27.45 units on a scale | Standard Deviation 27.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 360 | -40.29 units on a scale | Standard Deviation 28.74 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 348 | -28.87 units on a scale | Standard Deviation 31.14 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 40 | -29.23 units on a scale | Standard Deviation 27.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 44 | -29.01 units on a scale | Standard Deviation 27.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 48 | -29.80 units on a scale | Standard Deviation 27.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | EOS | -18.67 units on a scale | Standard Deviation 29.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 336 | -33.11 units on a scale | Standard Deviation 29.66 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 60 | -30.39 units on a scale | Standard Deviation 28.54 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 2 | -11.31 units on a scale | Standard Deviation 24.37 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 324 | -35.50 units on a scale | Standard Deviation 30.28 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 72 | -31.18 units on a scale | Standard Deviation 28.44 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 4 | -13.42 units on a scale | Standard Deviation 25.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 312 | -37.52 units on a scale | Standard Deviation 30.54 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 84 | -29.73 units on a scale | Standard Deviation 30.45 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 8 | -17.89 units on a scale | Standard Deviation 27.08 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 300 | -36.97 units on a scale | Standard Deviation 33.07 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 96 | -32.65 units on a scale | Standard Deviation 30.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 12 | -20.60 units on a scale | Standard Deviation 26.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 288 | -35.51 units on a scale | Standard Deviation 32.04 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 108 | -31.75 units on a scale | Standard Deviation 30.27 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 0 | -6.82 units on a scale | Standard Deviation 25.41 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 276 | -36.39 units on a scale | Standard Deviation 30.81 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 120 | -31.87 units on a scale | Standard Deviation 29.95 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 36 | -37.33 units on a scale | Standard Deviation 30.74 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 180 | -38.41 units on a scale | Standard Deviation 32.82 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 0 | -37.24 units on a scale | Standard Deviation 29.85 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 12 | -36.80 units on a scale | Standard Deviation 30.55 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 24 | -37.13 units on a scale | Standard Deviation 30.97 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 48 | -36.12 units on a scale | Standard Deviation 29.92 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 60 | -36.18 units on a scale | Standard Deviation 30.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 72 | -36.86 units on a scale | Standard Deviation 29.67 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 84 | -35.33 units on a scale | Standard Deviation 31.1 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 96 | -35.75 units on a scale | Standard Deviation 30.98 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 108 | -35.54 units on a scale | Standard Deviation 31.35 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 120 | -38.88 units on a scale | Standard Deviation 29.82 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 132 | -38.66 units on a scale | Standard Deviation 30.54 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 144 | -38.99 units on a scale | Standard Deviation 31.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 156 | -39.62 units on a scale | Standard Deviation 29.17 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 168 | -38.36 units on a scale | Standard Deviation 28.96 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 192 | -49.90 units on a scale | Standard Deviation 33.93 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 204 | -83.50 units on a scale | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | EOT | -33.53 units on a scale | Standard Deviation 32.73 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | EOS | -27.86 units on a scale | Standard Deviation 33.15 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 180 | -38.41 units on a scale | Standard Deviation 25.29 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 156 | -38.45 units on a scale | Standard Deviation 26.52 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 144 | -37.44 units on a scale | Standard Deviation 27.31 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 132 | -37.79 units on a scale | Standard Deviation 27.53 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 120 | -39.56 units on a scale | Standard Deviation 27.28 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 108 | -39.69 units on a scale | Standard Deviation 26.38 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 96 | -38.50 units on a scale | Standard Deviation 27.57 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 84 | -38.26 units on a scale | Standard Deviation 25.81 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 72 | -38.42 units on a scale | Standard Deviation 25.49 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 60 | -37.46 units on a scale | Standard Deviation 26.55 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 48 | -37.40 units on a scale | Standard Deviation 26.38 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 36 | -37.57 units on a scale | Standard Deviation 25.19 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 168 | -38.89 units on a scale | Standard Deviation 26.37 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 24 | -36.25 units on a scale | Standard Deviation 27.07 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 12 | -34.81 units on a scale | Standard Deviation 27.68 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | EOS | -22.79 units on a scale | Standard Deviation 30.38 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | EOT | -36.57 units on a scale | Standard Deviation 28.95 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 192 | -42.09 units on a scale | Standard Deviation 25.39 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 0 | -35.60 units on a scale | Standard Deviation 26.98 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372 | Week 204 | -57.00 units on a scale | — |
Secondary
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | EOT | -7.8 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 60 | -8.4 swollen joint count | Standard Deviation 6.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 24 | -7.6 swollen joint count | Standard Deviation 5.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | EOS | -6.3 swollen joint count | Standard Deviation 7.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 144 | -9.1 swollen joint count | Standard Deviation 5.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 20 | -7.4 swollen joint count | Standard Deviation 6.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 0 | -3.8 swollen joint count | Standard Deviation 5.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 84 | -8.7 swollen joint count | Standard Deviation 5.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 16 | -7.1 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 2 | -4.6 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 4 | -4.8 swollen joint count | Standard Deviation 6.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 8 | -6.1 swollen joint count | Standard Deviation 6.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 12 | -6.7 swollen joint count | Standard Deviation 6.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 48 | -8.7 swollen joint count | Standard Deviation 5.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 156 | -8.9 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 120 | -8.7 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 44 | -8.6 swollen joint count | Standard Deviation 5.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 168 | -9.2 swollen joint count | Standard Deviation 5.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 108 | -9.0 swollen joint count | Standard Deviation 5.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 40 | -8.1 swollen joint count | Standard Deviation 5.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 180 | -9.2 swollen joint count | Standard Deviation 5.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 72 | -8.6 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 36 | -7.9 swollen joint count | Standard Deviation 5.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 192 | -9.1 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 132 | -9.0 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 32 | -7.5 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 204 | -9.5 swollen joint count | Standard Deviation 5.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 96 | -8.8 swollen joint count | Standard Deviation 5.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 28 | -7.6 swollen joint count | Standard Deviation 6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 216 | -9.2 swollen joint count | Standard Deviation 6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 228 | -9.4 swollen joint count | Standard Deviation 5.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 240 | -9.7 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 252 | -9.6 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 264 | -9.7 swollen joint count | Standard Deviation 5.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 276 | -9.9 swollen joint count | Standard Deviation 5.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 288 | -9.5 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 300 | -9.7 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 312 | -9.4 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 324 | -9.5 swollen joint count | Standard Deviation 5.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 336 | -9.4 swollen joint count | Standard Deviation 5.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 348 | -9.4 swollen joint count | Standard Deviation 5.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 360 | -11.0 swollen joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 372 | -18.0 swollen joint count | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 96 | -10.6 swollen joint count | Standard Deviation 7 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 108 | -10.7 swollen joint count | Standard Deviation 7.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 120 | -11.1 swollen joint count | Standard Deviation 7.3 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 132 | -11.2 swollen joint count | Standard Deviation 7.3 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 144 | -11.2 swollen joint count | Standard Deviation 7.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 156 | -12.4 swollen joint count | Standard Deviation 8.1 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 168 | -11.4 swollen joint count | Standard Deviation 7 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 180 | -10.6 swollen joint count | Standard Deviation 6.2 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 192 | -9.0 swollen joint count | Standard Deviation 7.3 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 204 | -6.0 swollen joint count | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | EOT | -9.7 swollen joint count | Standard Deviation 7.1 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | EOS | -8.2 swollen joint count | Standard Deviation 7.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 0 | -9.6 swollen joint count | Standard Deviation 6.9 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 12 | -9.5 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 24 | -9.9 swollen joint count | Standard Deviation 6.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 36 | -10.3 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 48 | -10.4 swollen joint count | Standard Deviation 6.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 60 | -10.3 swollen joint count | Standard Deviation 6.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 72 | -10.3 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 84 | -10.2 swollen joint count | Standard Deviation 6.7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 204 | -17.0 swollen joint count | — |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 192 | -11.3 swollen joint count | Standard Deviation 7.5 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 180 | -11.9 swollen joint count | Standard Deviation 7.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 72 | -11.3 swollen joint count | Standard Deviation 6.7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 36 | -11.1 swollen joint count | Standard Deviation 6.5 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 168 | -11.7 swollen joint count | Standard Deviation 6.8 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 156 | -11.4 swollen joint count | Standard Deviation 7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 144 | -11.3 swollen joint count | Standard Deviation 6.7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 108 | -11.5 swollen joint count | Standard Deviation 6.9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 48 | -11.0 swollen joint count | Standard Deviation 6.7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 132 | -11.5 swollen joint count | Standard Deviation 6.8 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 96 | -11.3 swollen joint count | Standard Deviation 6.5 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 60 | -11.1 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 120 | -11.4 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 12 | -10.4 swollen joint count | Standard Deviation 6.4 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 0 | -10.5 swollen joint count | Standard Deviation 6.4 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | EOS | -9.3 swollen joint count | Standard Deviation 7.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | EOT | -11.1 swollen joint count | Standard Deviation 6.8 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 84 | -11.2 swollen joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372 | Week 24 | -10.8 swollen joint count | Standard Deviation 6.4 |
Secondary
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 264 | -11.7 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 132 | -10.8 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 44 | -10.9 tender joint count | Standard Deviation 8.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 252 | -11.8 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 144 | -11.1 tender joint count | Standard Deviation 9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 48 | -10.7 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 240 | -11.7 tender joint count | Standard Deviation 8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 156 | -11.2 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 372 | -23.0 tender joint count | — |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 228 | -11.7 tender joint count | Standard Deviation 7.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 168 | -11.3 tender joint count | Standard Deviation 8.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 204 | -11.8 tender joint count | Standard Deviation 7.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 216 | -11.7 tender joint count | Standard Deviation 8.1 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 180 | -11.3 tender joint count | Standard Deviation 8.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 324 | -12.0 tender joint count | Standard Deviation 8.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 192 | -11.4 tender joint count | Standard Deviation 8.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 0 | -4.3 tender joint count | Standard Deviation 8.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 20 | -9.5 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 360 | -13.8 tender joint count | Standard Deviation 5.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 2 | -5.3 tender joint count | Standard Deviation 7.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 4 | -5.7 tender joint count | Standard Deviation 8.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 8 | -7.7 tender joint count | Standard Deviation 8.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 12 | -8.7 tender joint count | Standard Deviation 8.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 348 | -11.2 tender joint count | Standard Deviation 5.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 16 | -9.4 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | EOS | -8.6 tender joint count | Standard Deviation 9.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 60 | -10.8 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 28 | -10.0 tender joint count | Standard Deviation 8.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 336 | -11.5 tender joint count | Standard Deviation 6.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 72 | -10.4 tender joint count | Standard Deviation 8.8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 32 | -9.5 tender joint count | Standard Deviation 8.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 312 | -11.9 tender joint count | Standard Deviation 8.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 84 | -10.7 tender joint count | Standard Deviation 8.7 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 36 | -10.0 tender joint count | Standard Deviation 8 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 300 | -11.5 tender joint count | Standard Deviation 8.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 96 | -10.8 tender joint count | Standard Deviation 7.9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 24 | -9.8 tender joint count | Standard Deviation 9 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 288 | -11.5 tender joint count | Standard Deviation 8.5 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 108 | -10.7 tender joint count | Standard Deviation 8.2 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | EOT | -10.2 tender joint count | Standard Deviation 9.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 276 | -12.0 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 120 | -10.6 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 40 | -10.4 tender joint count | Standard Deviation 8.1 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 204 | -8.0 tender joint count | — |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 24 | -11.9 tender joint count | Standard Deviation 8.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 36 | -12.4 tender joint count | Standard Deviation 8.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 0 | -11.7 tender joint count | Standard Deviation 8.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 48 | -11.9 tender joint count | Standard Deviation 8.8 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 60 | -11.9 tender joint count | Standard Deviation 9.2 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 72 | -11.9 tender joint count | Standard Deviation 9.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 84 | -11.9 tender joint count | Standard Deviation 9 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 96 | -12.3 tender joint count | Standard Deviation 9.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 108 | -12.3 tender joint count | Standard Deviation 9.3 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 120 | -12.7 tender joint count | Standard Deviation 9.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 132 | -12.8 tender joint count | Standard Deviation 9.9 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 144 | -12.9 tender joint count | Standard Deviation 9.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 156 | -14.1 tender joint count | Standard Deviation 10.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 168 | -11.8 tender joint count | Standard Deviation 10 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 180 | -12.2 tender joint count | Standard Deviation 7.5 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 192 | -11.8 tender joint count | Standard Deviation 5.6 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 12 | -11.8 tender joint count | Standard Deviation 8.9 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | EOT | -11.5 tender joint count | Standard Deviation 9.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | EOS | -9.1 tender joint count | Standard Deviation 7.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 204 | -17.0 tender joint count | — |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 168 | -13.2 tender joint count | Standard Deviation 9.1 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 156 | -13.3 tender joint count | Standard Deviation 9.7 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 144 | -13.3 tender joint count | Standard Deviation 9.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 132 | -13.8 tender joint count | Standard Deviation 9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 120 | -13.5 tender joint count | Standard Deviation 9.2 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 108 | -13.8 tender joint count | Standard Deviation 8.9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 96 | -13.1 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 84 | -12.9 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 72 | -12.8 tender joint count | Standard Deviation 8.5 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 60 | -12.4 tender joint count | Standard Deviation 8.3 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 12 | -11.8 tender joint count | Standard Deviation 8.1 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 0 | -11.5 tender joint count | Standard Deviation 8.4 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 48 | -12.3 tender joint count | Standard Deviation 8.2 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 36 | -12.3 tender joint count | Standard Deviation 7.9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | EOS | -9.4 tender joint count | Standard Deviation 9.9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 180 | -14.2 tender joint count | Standard Deviation 9.9 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | EOT | -12.6 tender joint count | Standard Deviation 8.6 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 192 | -13.2 tender joint count | Standard Deviation 10.8 |
| Participants Who Completed 015K-CL-RAJ4 | Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372 | Week 24 | -12.1 tender joint count | Standard Deviation 8 |
Secondary
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Time frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Population: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 0 | -5.36 percent work time missed | Standard Deviation 16.76 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 24 | -4.81 percent work time missed | Standard Deviation 17.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 48 | -4.52 percent work time missed | Standard Deviation 19.86 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 72 | -4.73 percent work time missed | Standard Deviation 18.43 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 96 | -4.74 percent work time missed | Standard Deviation 19 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 120 | -5.15 percent work time missed | Standard Deviation 20.38 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 144 | -3.21 percent work time missed | Standard Deviation 14.26 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 168 | -8.65 percent work time missed | Standard Deviation 21.3 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 192 | 0.00 percent work time missed | Standard Deviation 0 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | EOT | -2.76 percent work time missed | Standard Deviation 20.13 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 168 | -5.19 percent work time missed | Standard Deviation 19.82 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 0 | -2.20 percent work time missed | Standard Deviation 18.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 120 | -4.49 percent work time missed | Standard Deviation 17.14 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 24 | -3.29 percent work time missed | Standard Deviation 14.3 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | EOT | -1.96 percent work time missed | Standard Deviation 17.64 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 48 | -3.30 percent work time missed | Standard Deviation 17.16 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 144 | -1.26 percent work time missed | Standard Deviation 20.09 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 72 | -3.17 percent work time missed | Standard Deviation 15.47 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 192 | -2.29 percent work time missed | Standard Deviation 6.62 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192 | Week 96 | -3.13 percent work time missed | Standard Deviation 14.38 |
Secondary
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Time frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Population: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 0 | -28.16 percent activity impairment | Standard Deviation 29.69 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 24 | -27.38 percent activity impairment | Standard Deviation 30.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 48 | -27.81 percent activity impairment | Standard Deviation 30.76 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 72 | -28.09 percent activity impairment | Standard Deviation 31.12 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 96 | -27.92 percent activity impairment | Standard Deviation 30.69 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 120 | -29.26 percent activity impairment | Standard Deviation 31.56 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 144 | -26.39 percent activity impairment | Standard Deviation 32.57 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 168 | -20.81 percent activity impairment | Standard Deviation 26.71 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 192 | -20.00 percent activity impairment | Standard Deviation 30.24 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | EOT | -25.55 percent activity impairment | Standard Deviation 32.04 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 168 | -26.53 percent activity impairment | Standard Deviation 31.64 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 0 | -25.39 percent activity impairment | Standard Deviation 29.77 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 120 | -33.07 percent activity impairment | Standard Deviation 30.69 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 24 | -29.31 percent activity impairment | Standard Deviation 28.92 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | EOT | -27.87 percent activity impairment | Standard Deviation 32.4 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 48 | -28.85 percent activity impairment | Standard Deviation 29.34 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 144 | -31.11 percent activity impairment | Standard Deviation 30.68 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 72 | -31.59 percent activity impairment | Standard Deviation 30.71 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 192 | -23.18 percent activity impairment | Standard Deviation 32.13 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192 | Week 96 | -30.69 percent activity impairment | Standard Deviation 29.3 |
Secondary
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.
Time frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Population: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 0 | -21.05 percent work impairment | Standard Deviation 33.06 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 24 | -21.94 percent work impairment | Standard Deviation 32.6 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 48 | -20.70 percent work impairment | Standard Deviation 31.82 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 72 | -21.06 percent work impairment | Standard Deviation 31.47 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 96 | -20.11 percent work impairment | Standard Deviation 31.39 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 120 | -24.40 percent work impairment | Standard Deviation 30.15 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 144 | -18.08 percent work impairment | Standard Deviation 30.62 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 168 | -17.06 percent work impairment | Standard Deviation 34.96 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 192 | -15.00 percent work impairment | Standard Deviation 21.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | EOT | -21.49 percent work impairment | Standard Deviation 33.56 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 168 | -23.24 percent work impairment | Standard Deviation 31.79 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 0 | -22.18 percent work impairment | Standard Deviation 28.64 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 120 | -30.00 percent work impairment | Standard Deviation 29.38 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 24 | -24.79 percent work impairment | Standard Deviation 26.64 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | EOT | -24.13 percent work impairment | Standard Deviation 29.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 48 | -25.17 percent work impairment | Standard Deviation 27.33 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 144 | -27.16 percent work impairment | Standard Deviation 31.37 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 72 | -27.12 percent work impairment | Standard Deviation 27.72 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 192 | -28.00 percent work impairment | Standard Deviation 35.53 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192 | Week 96 | -28.54 percent work impairment | Standard Deviation 26.94 |
Secondary
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. Negative values indicate improvement from baseline.
Time frame: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOT
Population: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 24 | -22.45 percent overall work impairment | Standard Deviation 32.86 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 0 | -22.24 percent overall work impairment | Standard Deviation 33.23 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 48 | -20.80 percent overall work impairment | Standard Deviation 32.72 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 72 | -21.59 percent overall work impairment | Standard Deviation 32.4 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 96 | -20.58 percent overall work impairment | Standard Deviation 32.29 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 120 | -24.71 percent overall work impairment | Standard Deviation 30.92 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 144 | -18.29 percent overall work impairment | Standard Deviation 31.64 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 168 | -19.03 percent overall work impairment | Standard Deviation 36.72 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 192 | -15.00 percent overall work impairment | Standard Deviation 21.21 |
| Participants Who Completed 015K-CL-RAJ1 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | EOT | -20.75 percent overall work impairment | Standard Deviation 33.46 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 168 | -24.76 percent overall work impairment | Standard Deviation 32.39 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 120 | -31.40 percent overall work impairment | Standard Deviation 30.13 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 0 | -22.20 percent overall work impairment | Standard Deviation 30.83 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 24 | -25.78 percent overall work impairment | Standard Deviation 27.99 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | EOT | -24.63 percent overall work impairment | Standard Deviation 31.29 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 48 | -25.32 percent overall work impairment | Standard Deviation 30 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 144 | -26.76 percent overall work impairment | Standard Deviation 33.82 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 72 | -27.41 percent overall work impairment | Standard Deviation 28.98 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 192 | -28.06 percent overall work impairment | Standard Deviation 36.25 |
| Participants Who Completed 015K-CL-RAJ3 | Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192 | Week 96 | -28.93 percent overall work impairment | Standard Deviation 28.34 |
Secondary
Number of Participants Who Withdrew Due to Lack of Efficacy
Participants who discontinued due to lack of efficacy have been reported.
Time frame: Baseline up to week 372
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Number of Participants Who Withdrew Due to Lack of Efficacy | 19.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Number of Participants Who Withdrew Due to Lack of Efficacy | 4.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Number of Participants Who Withdrew Due to Lack of Efficacy | 3.4 percentage of participants |
Secondary
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 132 | 20.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 24 | 7.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 252 | 25.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 144 | 18.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | EOS | 10.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 240 | 24.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 156 | 17.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 228 | 24.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 168 | 21.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 28 | 9.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 216 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 180 | 21.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 32 | 10.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 336 | 24.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 192 | 21.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 36 | 11.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 204 | 23.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 2 | 4.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 360 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 40 | 8.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 44 | 11.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 48 | 11.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 4 | 5.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 348 | 15.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 60 | 10.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 8 | 4.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 324 | 23.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 72 | 11.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 12 | 4.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 312 | 24.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 84 | 14.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 0 | 1.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 300 | 24.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 96 | 17.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | EOT | 15.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 288 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 108 | 18.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 16 | 7.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 276 | 19.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 120 | 16.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 20 | 7.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 264 | 24.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 0 | 18.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 12 | 16.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 24 | 20.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 36 | 29.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 48 | 25.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 60 | 24.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 72 | 29.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 84 | 30.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 96 | 26.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 108 | 28.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 120 | 29.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 132 | 29.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 144 | 30.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 156 | 27.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 168 | 35.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 180 | 23.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 192 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | EOT | 25.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | EOS | 7.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 168 | 31.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 156 | 31.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 144 | 28.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 132 | 31.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 120 | 26.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 108 | 30.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 96 | 33.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 84 | 34.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 72 | 30.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 60 | 28.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 48 | 32.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 36 | 28.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 24 | 26.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 12 | 23.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | EOS | 12.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | EOT | 31.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 0 | 22.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 192 | 31.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372 | Week 180 | 34.8 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission, DAS28-CRP \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity.
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 348 | 65.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 8 | 15.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 204 | 65.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 60 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 40 | 36.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 44 | 39.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 324 | 71.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 48 | 39.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 120 | 57.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 336 | 60.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 72 | 46.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | EOT | 45.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 84 | 51.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 96 | 54.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 108 | 51.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 0 | 8.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 144 | 60.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 132 | 55.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 2 | 13.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 168 | 61.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 4 | 16.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 180 | 58.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 192 | 64.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 12 | 20.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 216 | 63.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 228 | 61.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 240 | 65.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 252 | 66.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 264 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 276 | 70.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 288 | 63.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 300 | 67.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 312 | 65.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 360 | 81.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | EOS | 22.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 16 | 23.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 20 | 27.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 24 | 26.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 156 | 59.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 28 | 29.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 32 | 29.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 36 | 30.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 120 | 66.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 24 | 56.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 156 | 71.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 72 | 63.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 0 | 55.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 168 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 36 | 58.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 84 | 60.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | EOT | 57.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 96 | 63.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 192 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 144 | 66.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 180 | 66.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 12 | 53.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 48 | 56.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | EOS | 35.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 132 | 65.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 60 | 57.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 108 | 62.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 132 | 74.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 180 | 82.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | EOS | 44.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 0 | 58.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 12 | 60.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 24 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 36 | 65.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 108 | 72.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 60 | 66.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 72 | 71.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 84 | 70.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 96 | 71.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 120 | 76.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 48 | 69.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 144 | 74.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 156 | 72.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 168 | 72.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 192 | 68.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372 | EOT | 69.4 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission.
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 132 | 77.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 16 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 264 | 82.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 144 | 81.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 0 | 18.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 252 | 77.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 156 | 78.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 228 | 82.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 168 | 76.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 28 | 51.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 216 | 75.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 180 | 75.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 32 | 50.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 20 | 46.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 192 | 76.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 36 | 56.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 204 | 83.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 24 | 49.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 360 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 40 | 59.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 44 | 60.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 48 | 61.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | EOS | 40.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 348 | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 60 | 64.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 2 | 24.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 336 | 77.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 72 | 64.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 4 | 25.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 324 | 84.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 84 | 68.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 8 | 33.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 312 | 83.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 96 | 75.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 12 | 38.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 300 | 82.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 108 | 77.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 240 | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 288 | 83.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 120 | 74.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | EOT | 61.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 276 | 86.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 0 | 73.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 12 | 73.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 24 | 72.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 36 | 75.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 48 | 75.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 60 | 75.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 72 | 79.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 84 | 79.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 96 | 80.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 108 | 78.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 120 | 85.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 132 | 84.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 144 | 82.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 156 | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 168 | 78.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 180 | 81.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 192 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | EOT | 71.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | EOS | 47.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 168 | 86.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 156 | 85.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 144 | 86.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 132 | 87.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 120 | 86.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 108 | 87.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 96 | 86.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 84 | 83.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 72 | 84.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 60 | 83.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 48 | 82.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 36 | 79.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 24 | 78.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 12 | 74.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | EOS | 60.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | EOT | 84.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 0 | 72.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 192 | 90.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372 | Week 180 | 89.1 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission, DAS28-ESR \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity.
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 0 | 4.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 276 | 38.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 132 | 34.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | EOT | 27.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 252 | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 144 | 35.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 16 | 13.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 240 | 37.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 156 | 32.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 20 | 12.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 228 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 168 | 36.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 24 | 13.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 216 | 35.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 180 | 33.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 192 | 39.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 204 | 35.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 32 | 16.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 36 | 18.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 264 | 32.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 360 | 31.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 40 | 17.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 44 | 20.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 48 | 20.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 28 | 18.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 348 | 27.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 60 | 22.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | EOS | 14.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 336 | 32.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 72 | 28.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 2 | 4.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 324 | 39.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 84 | 26.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 4 | 7.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 312 | 38.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 96 | 34.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 8 | 7.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 300 | 35.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 108 | 32.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 12 | 12.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 288 | 41.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 120 | 31.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | EOS | 20.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 0 | 30.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 12 | 36.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 24 | 35.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 36 | 37.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 48 | 39.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 60 | 36.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 72 | 47.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 84 | 41.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 96 | 39.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 108 | 47.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 120 | 46.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 132 | 47.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 144 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 156 | 48.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 168 | 54.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 180 | 38.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 192 | 37.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 204 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | EOT | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 168 | 47.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 156 | 53.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 144 | 55.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 132 | 54.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 120 | 49.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 108 | 52.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 96 | 48.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 84 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 72 | 51.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 60 | 45.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 48 | 48.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 36 | 45.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 24 | 43.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | EOS | 20.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 12 | 39.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 180 | 55.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | EOT | 49.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 192 | 45.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372 | Week 0 | 38.0 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission.
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 264 | 56.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 132 | 55.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 20 | 23.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 252 | 60.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 144 | 58.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 24 | 28.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 240 | 60.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 156 | 55.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 228 | 59.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 216 | 54.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 168 | 56.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | EOS | 23.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 204 | 60.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 180 | 57.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 360 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 192 | 55.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 28 | 29.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 32 | 31.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 36 | 32.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | EOT | 42.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 348 | 52.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 40 | 30.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 44 | 38.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 48 | 40.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 2 | 13.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 336 | 52.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 60 | 40.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 4 | 14.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 324 | 60.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 72 | 43.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 8 | 14.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 312 | 57.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 84 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 12 | 22.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 0 | 8.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 300 | 60.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 96 | 53.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 288 | 57.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 108 | 51.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 276 | 62.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 120 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 16 | 22.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 156 | 67.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 0 | 56.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 12 | 53.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 24 | 54.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 36 | 58.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 48 | 58.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 60 | 57.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 72 | 59.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 108 | 64.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 84 | 57.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 96 | 56.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 120 | 66.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 132 | 67.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 144 | 63.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 168 | 64.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 180 | 57.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 192 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | EOT | 54.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | EOS | 35.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | EOS | 40.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 156 | 67.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | EOT | 67.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 144 | 71.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 132 | 72.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 120 | 71.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 108 | 70.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 96 | 71.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 84 | 69.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 72 | 69.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 60 | 67.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 48 | 65.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 36 | 64.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 24 | 62.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 12 | 59.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 180 | 75.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 0 | 55.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 192 | 68.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372 | Week 168 | 69.7 percentage of participants |
Secondary
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 24 | 50.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 264 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 144 | 55.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 2 | 37.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 252 | 54.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 156 | 53.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 240 | 50.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 168 | 53.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 28 | 54.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 228 | 52.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 180 | 57.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 32 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 216 | 55.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 192 | 55.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 36 | 48.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 204 | 51.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 4 | 40.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 360 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 40 | 48.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 44 | 50.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 48 | 50.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 8 | 41.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 348 | 47.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 60 | 54.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 12 | 48.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 336 | 50.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 72 | 54.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | EOS | 44.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 324 | 51.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 84 | 53.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 0 | 35.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 312 | 51.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 96 | 51.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | EOT | 46.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 300 | 54.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 108 | 54.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 16 | 51.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 288 | 47.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 120 | 52.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 20 | 49.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 276 | 54.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 132 | 53.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 84 | 63.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 0 | 59.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 12 | 61.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 24 | 59.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 36 | 55.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 48 | 58.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 60 | 59.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 72 | 59.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 96 | 57.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 108 | 56.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 120 | 62.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 132 | 57.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 144 | 61.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 156 | 70.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 168 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 180 | 47.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 192 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | EOT | 55.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | EOS | 44.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 180 | 71.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 168 | 69.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 156 | 76.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 144 | 75.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 132 | 74.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 120 | 73.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 108 | 73.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 96 | 73.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 84 | 69.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 72 | 69.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 60 | 71.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 48 | 70.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 36 | 71.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 24 | 68.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 12 | 65.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | EOS | 56.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | EOT | 68.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 192 | 59.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 0 | 67.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372 | Week 204 | 100.0 percentage of participants |
Secondary
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. 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.
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 24 | 48.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 264 | 67.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 144 | 66.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 2 | 38.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 252 | 68.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 156 | 65.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 240 | 68.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 168 | 67.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 28 | 50.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 228 | 70.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 180 | 68.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 32 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 216 | 72.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 192 | 67.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 36 | 51.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 204 | 67.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 4 | 38.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 360 | 56.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 40 | 52.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 44 | 55.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 48 | 54.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 8 | 39.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 348 | 60.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 60 | 55.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 12 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 336 | 62.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 72 | 60.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | EOS | 35.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 324 | 70.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 84 | 62.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 0 | 37.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 312 | 67.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 96 | 62.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | EOT | 52.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 300 | 69.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 108 | 62.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 16 | 46.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 288 | 70.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 120 | 63.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 20 | 47.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 276 | 72.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 132 | 66.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 84 | 65.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 0 | 61.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 12 | 62.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 24 | 64.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 36 | 62.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 48 | 58.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 60 | 62.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 72 | 67.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 96 | 63.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 108 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 120 | 69.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 132 | 70.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 144 | 71.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 156 | 68.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 168 | 73.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 180 | 71.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 192 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | EOT | 62.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | EOS | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 180 | 73.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 168 | 68.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 156 | 67.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 144 | 69.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 132 | 68.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 120 | 68.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 108 | 67.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 96 | 69.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 84 | 69.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 72 | 68.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 60 | 67.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 48 | 65.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 36 | 64.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 24 | 65.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 12 | 63.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | EOS | 48.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | EOT | 63.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 192 | 59.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 0 | 62.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372 | Week 204 | 0.0 percentage of participants |
Secondary
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 49.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 4 | 42.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 8 | 47.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 12 | 43.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 51.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 264 | 43.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 276 | 100 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 288 | 41.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 300 | 100 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 312 | 43.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 324 | 33.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 336 | 37.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 348 | 22.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 360 | 43.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 372 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | EOT | 39.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 39.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 16 | 45.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 20 | 45.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 28 | 47.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 36 | 47.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 40 | 49.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 44 | 49.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 47.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 41.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 32 | 48.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 51.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 60 | 48.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 53.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 84 | 57.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 43.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 108 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 45.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 132 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 156 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 216 | 37.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 240 | 42.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 32.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 37.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 39.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 33.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 33.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | EOT | 35.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 37.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 30.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 39.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 37.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 33.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 37.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 38.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 31.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 39.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 37.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | EOT | 34.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 34.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 28.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 35.8 percentage of participants |
Secondary
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 312 | 48.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 324 | 66.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 336 | 43.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 348 | 11.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 360 | 56.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 372 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 44 | 47.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 45.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 60 | 47.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 47.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 84 | 50.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 43.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 108 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 44.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 132 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 53.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 156 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 276 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 288 | 48.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 300 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 52.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 216 | 51.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 240 | 53.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 264 | 52.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | EOT | 41.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 34.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 4 | 33.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 8 | 40.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 12 | 39.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 16 | 43.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 20 | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 44.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 28 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 32 | 44.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 36 | 45.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 40 | 47.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | EOT | 61.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 70 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 68.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 66.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 70.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 71.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 70.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 68.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 73.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 82.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | EOT | 306 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 74.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 75.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 71.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 77.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 77.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 74.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 73.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 79.3 percentage of participants |
Secondary
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Time frame: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 38.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 8 | 35.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 12 | 39.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 16 | 39.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 36.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 156 | 100 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 39.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 38.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 216 | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 240 | 41.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 26.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 20 | 38.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 28 | 39.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 40 | 38.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 264 | 37.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 276 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 288 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 300 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 312 | 45.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 324 | 83.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 336 | 39.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 348 | 22.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 360 | 31.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | EOT | 39.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 32 | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 36 | 33.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 44 | 38.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 40.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 60 | 39.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 4 | 27.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 84 | 29.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 38.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 108 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 39.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 132 | 0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 38.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 47.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 51.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 46.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | EOT | 43.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 47.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 35.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 42.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 44.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 45.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 120 | 49.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 24 | 48.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 192 | 31.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 0 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 72 | 46.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 144 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 96 | 48.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 48 | 47.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | EOT | 44.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372 | Week 168 | 40.8 percentage of participants |
Secondary
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 288 | 38.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 300 | 30.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 312 | 31.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 324 | 34.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 336 | 26.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 348 | 20.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 360 | 31.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | EOT | 24.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | EOS | 14.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 0 | 3.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 2 | 4.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 4 | 4.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 8 | 6.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 12 | 5.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 16 | 7.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 20 | 8.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 24 | 11.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 28 | 14.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 32 | 16.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 36 | 15.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 40 | 13.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 44 | 15.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 48 | 19.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 60 | 14.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 72 | 18.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 84 | 20.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 96 | 23.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 108 | 26.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 120 | 23.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 132 | 25.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 144 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 156 | 19.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 168 | 28.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 180 | 28.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 192 | 30.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 204 | 29.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 216 | 33.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 228 | 33.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 240 | 34.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 252 | 30.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 264 | 31.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 276 | 31.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 96 | 37.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | EOT | 34.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 132 | 44.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 24 | 29.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 0 | 23.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 168 | 51.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 204 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 144 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 36 | 30.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 108 | 37.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 84 | 33.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 192 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 156 | 41.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 48 | 33.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 180 | 33.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 120 | 39.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 60 | 28.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 12 | 24.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | EOS | 12.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 72 | 36.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 120 | 39.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 84 | 42.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 168 | 43.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | EOT | 42.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 96 | 42.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | EOS | 25.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 0 | 30.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 108 | 40.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 12 | 30.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 72 | 42.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 180 | 43.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 24 | 36.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 132 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 36 | 39.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 144 | 44.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 48 | 42.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 156 | 40.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 60 | 40.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372 | Week 192 | 45.5 percentage of participants |
Secondary
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
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. Percentage of participants with good or moderate response have been reported in this outcome measure.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 24 | 84.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 264 | 91.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 144 | 95.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 2 | 60.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 252 | 93.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 156 | 94.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 360 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 240 | 94.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 168 | 94.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 28 | 88.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 228 | 93.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 180 | 93.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 32 | 88.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 216 | 94.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 192 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 36 | 91.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 204 | 96.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 4 | 65.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 348 | 92.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 40 | 92.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 44 | 93.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 48 | 92.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 8 | 75.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 60 | 94.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 12 | 79.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 336 | 98.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 72 | 92.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | EOS | 72.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 324 | 98.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 84 | 92.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 0 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 312 | 94.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 96 | 94.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | EOT | 78.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 300 | 93.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 108 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 16 | 81.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 288 | 94.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 120 | 93.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 20 | 84.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 276 | 95.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 132 | 92.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 84 | 95.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 0 | 94.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 12 | 92.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 24 | 95.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 36 | 95.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 48 | 94.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 60 | 93.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 72 | 95.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 96 | 94.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 108 | 93.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 120 | 98.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 132 | 94.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 144 | 90.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 156 | 97.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 168 | 94.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 180 | 95.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 192 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | EOT | 89.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | EOS | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 180 | 97.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 168 | 98.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 156 | 98.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 144 | 96.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 132 | 97.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 120 | 96.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 108 | 98.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 96 | 97.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 84 | 96.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 72 | 96.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 60 | 96.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 48 | 97.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 36 | 96.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 24 | 96.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 12 | 94.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | EOS | 83.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | EOT | 95.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 192 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 0 | 94.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372 | Week 204 | 100.0 percentage of participants |
Secondary
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
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. Percentage of participants with good or moderate response have been reported in this outcome measure.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 24 | 84.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 264 | 92.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 144 | 93.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 2 | 54.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 252 | 92.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 156 | 94.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 240 | 92.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 168 | 92.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 28 | 87.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 228 | 92.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 180 | 93.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 32 | 84.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 216 | 93.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 192 | 94.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 36 | 91.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 204 | 95.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 4 | 59.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 360 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 40 | 89.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 44 | 93.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 48 | 92.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 8 | 70.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 348 | 92.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 60 | 93.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 12 | 75.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 336 | 94.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 72 | 90.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | EOS | 67.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 324 | 96.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 84 | 89.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 0 | 41.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 312 | 94.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 96 | 92.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | EOT | 76.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 300 | 95.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 108 | 92.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 16 | 78.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 288 | 92.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 120 | 91.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 20 | 85.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 276 | 94.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 132 | 92.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 84 | 92.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 0 | 89.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 12 | 91.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 24 | 92.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 36 | 92.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 48 | 94.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 60 | 92.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 72 | 91.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 96 | 94.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 108 | 91.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 120 | 93.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 132 | 89.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 144 | 87.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 156 | 95.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 168 | 86.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 180 | 90.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 192 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | EOT | 87.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | EOS | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 180 | 93.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 168 | 96.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 156 | 96.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 144 | 97.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 132 | 97.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 120 | 96.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 108 | 97.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 96 | 97.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 84 | 95.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 72 | 96.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 60 | 94.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 48 | 95.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 36 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 24 | 95.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 12 | 92.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | EOS | 82.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | EOT | 93.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 192 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 0 | 93.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372 | Week 204 | 100.0 percentage of participants |
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
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. Percentage of participants with good response have been reported in this outcome measure.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 28 | 47.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 132 | 73.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 2 | 18.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 4 | 19.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 8 | 27.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 12 | 34.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 16 | 36.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 20 | 43.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 24 | 44.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 32 | 46.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 36 | 49.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 40 | 53.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 44 | 53.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 48 | 56.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 60 | 58.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 72 | 59.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 84 | 63.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 96 | 72.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 108 | 72.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 120 | 70.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 144 | 78.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 156 | 74.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 168 | 73.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 180 | 71.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 192 | 74.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 204 | 77.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 216 | 73.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 228 | 79.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 240 | 78.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 252 | 76.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 264 | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 276 | 81.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 288 | 78.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 300 | 80.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 312 | 81.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 324 | 79.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 336 | 71.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 348 | 75.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 360 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | EOT | 58.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | EOS | 38.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 0 | 11.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 156 | 75.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 48 | 73.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 24 | 70.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 180 | 76.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 60 | 71.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 144 | 80.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 72 | 76.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 12 | 70.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | EOS | 43.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 84 | 75.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 36 | 72.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 192 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 96 | 77.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 132 | 80.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 168 | 75.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 108 | 75.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 0 | 71.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | EOT | 69.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 120 | 83.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | EOS | 58.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 120 | 85.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 0 | 71.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 132 | 85.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 144 | 85.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 24 | 77.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 156 | 84.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | EOT | 83.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 36 | 78.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 168 | 86.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 12 | 72.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 48 | 80.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 60 | 82.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 180 | 84.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 72 | 84.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 84 | 82.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 96 | 84.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 192 | 86.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372 | Week 108 | 85.8 percentage of participants |
Secondary
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
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. Percentage of participants with good response have been reported in the outcome measure.
Time frame: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 24 | 27.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 264 | 56.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 144 | 56.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 2 | 11.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 252 | 57.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 156 | 53.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 240 | 56.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 168 | 55.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 28 | 29.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 228 | 58.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 180 | 56.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 32 | 30.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 216 | 52.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 192 | 54.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 36 | 30.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 204 | 59.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 4 | 13.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 360 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 40 | 28.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 44 | 36.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 48 | 38.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 8 | 13.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 348 | 52.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 60 | 39.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 12 | 21.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 336 | 50.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 72 | 42.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | EOS | 20.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 324 | 59.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 84 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 0 | 7.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 312 | 54.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 96 | 51.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | EOT | 41.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 300 | 58.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 108 | 50.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 16 | 21.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 288 | 54.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 120 | 46.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 20 | 23.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 276 | 60.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 132 | 54.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 84 | 54.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 0 | 54.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 12 | 50.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 24 | 52.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 36 | 54.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 48 | 56.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 60 | 55.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 72 | 58.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 96 | 54.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 108 | 61.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 120 | 64.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 132 | 64.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 144 | 60.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 156 | 65.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 168 | 64.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 180 | 57.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 192 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | EOT | 52.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | EOS | 35.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 180 | 73.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 168 | 68.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 156 | 67.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 144 | 68.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 132 | 71.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 120 | 69.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 108 | 68.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 96 | 69.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 84 | 68.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 72 | 68.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 60 | 66.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 48 | 65.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 36 | 63.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 24 | 61.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 12 | 58.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | EOS | 40.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | EOT | 65.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 192 | 63.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 0 | 54.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372 | Week 204 | 100.0 percentage of participants |
Secondary
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 24 | 63.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 264 | 74.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 144 | 81.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 2 | 37.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 252 | 77.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 156 | 77.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 240 | 76.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 168 | 77.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 28 | 65.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 228 | 80.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 180 | 80.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 32 | 63.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 216 | 78.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 192 | 80.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 36 | 66.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 204 | 82.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 4 | 42.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 360 | 81.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 40 | 67.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 44 | 70.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 48 | 74.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 8 | 45.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 348 | 65.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 60 | 73.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 12 | 52.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 336 | 75.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 72 | 76.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | EOS | 53.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 324 | 79.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 84 | 74.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 0 | 28.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 312 | 78.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 96 | 77.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | EOT | 64.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 300 | 75.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 108 | 75.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 16 | 61.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 288 | 73.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 120 | 76.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 20 | 63.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 276 | 79.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 132 | 77.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 84 | 80.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 0 | 80.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 12 | 80.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 24 | 84.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 36 | 82.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 48 | 82.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 60 | 81.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 72 | 84.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 96 | 83.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 108 | 79.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 120 | 83.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 132 | 80.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 144 | 84.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 156 | 90.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 168 | 73.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 180 | 81.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 192 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | EOT | 74.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | EOS | 67.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 180 | 93.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 168 | 90.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 156 | 91.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 144 | 91.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 132 | 90.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 120 | 90.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 108 | 90.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 96 | 90.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 84 | 89.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 72 | 90.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 60 | 88.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 48 | 88.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 36 | 91.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 24 | 88.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 12 | 85.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | EOS | 68.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | EOT | 87.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 192 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 0 | 85.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372 | Week 204 | 100.0 percentage of participants |
Secondary
Percentage of Participants With an ACR50-CRP Response Through Week 372
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 8 | 23.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 20 | 34.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 24 | 36.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 32 | 38.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 40 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 84 | 52.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 132 | 59.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 156 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 168 | 64.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 0 | 8.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 2 | 9.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 16 | 30.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 48 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 28 | 40.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 36 | 41.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 44 | 46.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 60 | 49.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 72 | 55.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 96 | 54.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 108 | 56.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 120 | 56.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 144 | 63.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 180 | 61.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 192 | 63.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 204 | 68.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 216 | 61.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 228 | 64.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 240 | 61.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 252 | 62.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 264 | 63.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 276 | 65.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 288 | 61.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 300 | 63.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 312 | 59.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 324 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 336 | 60.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 348 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 360 | 68.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | EOT | 45.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | EOS | 31.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 4 | 14.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 12 | 28.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 48 | 67.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 132 | 72.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 168 | 70.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | EOT | 59.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 72 | 66.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 144 | 68.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 12 | 60.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 96 | 64.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 108 | 64.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 120 | 67.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 180 | 71.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 24 | 63.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 36 | 65.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 84 | 63.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | EOS | 41.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 192 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 60 | 64.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 156 | 75.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 0 | 62.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 192 | 77.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 0 | 67.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 84 | 75.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 12 | 67.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 96 | 77.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 120 | 76.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 72 | 79.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 108 | 77.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 132 | 78.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 156 | 74.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 168 | 78.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | EOT | 73.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 144 | 77.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | EOS | 47.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 24 | 73.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 180 | 76.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 36 | 74.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 48 | 75.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-CRP Response Through Week 372 | Week 60 | 77.5 percentage of participants |
Secondary
Percentage of Participants With an ACR50-ESR Response Through Week 372
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 20 | 31.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 264 | 55.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 144 | 60.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 24 | 33.2 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 252 | 57.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 156 | 61.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | EOS | 28.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 240 | 56.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 168 | 63.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 372 | 100.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 228 | 63.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 180 | 57.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 28 | 38.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 216 | 58.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 192 | 60.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 32 | 34.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 204 | 63.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 36 | 38.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 2 | 9.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 40 | 41.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 44 | 44.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 48 | 45.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 4 | 13.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 360 | 62.5 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 60 | 45.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 8 | 21.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 348 | 45.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 72 | 51.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 12 | 24.2 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 336 | 56.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 84 | 49.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 324 | 54.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 312 | 55.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 96 | 54.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 0 | 8.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 300 | 60.5 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 108 | 54.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | EOT | 45.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 288 | 58.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 120 | 55.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 16 | 29.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 276 | 59.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 132 | 58.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 84 | 61.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 0 | 58.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 12 | 58.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 24 | 60.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 36 | 64.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 48 | 62.2 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 60 | 62.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 72 | 65.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 96 | 61.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 108 | 63.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 120 | 64.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 132 | 71.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 144 | 66.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 156 | 70.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 168 | 67.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 180 | 61.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 192 | 62.5 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 204 | 100.0 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | EOT | 58.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | EOS | 38.5 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 180 | 73.9 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 168 | 76.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 156 | 72.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 144 | 77.2 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 132 | 75.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 120 | 75.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 108 | 75.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 96 | 74.6 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 84 | 73.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 36 | 72.2 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 72 | 76.8 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 60 | 74.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 48 | 74.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 24 | 71.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 12 | 66.4 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | EOS | 46.1 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | EOT | 72.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 192 | 72.7 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 0 | 65.3 percentage of Participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR50-ESR Response Through Week 372 | Week 204 | 100.0 percentage of Participants |
Secondary
Percentage of Participants With an ACR70-CRP Response Through Week 372
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 24 | 17.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 264 | 43.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 144 | 36.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 2 | 4.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 252 | 46.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 156 | 39.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 240 | 44.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 168 | 39.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 28 | 18.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 228 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 180 | 42.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 32 | 17.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 216 | 41.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 192 | 44.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 36 | 22.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 204 | 46.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 4 | 6.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 360 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 40 | 22.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 44 | 23.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 48 | 25.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 8 | 9.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 348 | 27.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 60 | 24.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 12 | 12.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 336 | 41.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 72 | 26.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | EOS | 19.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 324 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 84 | 29.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 0 | 3.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 312 | 46.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 96 | 29.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | EOT | 29.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 300 | 40.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 108 | 35.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 16 | 12.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 288 | 41.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 120 | 35.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 20 | 13.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 276 | 44.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 132 | 36.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 84 | 44.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 0 | 42.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 12 | 40.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 24 | 40.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 36 | 42.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 48 | 41.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 60 | 45.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 72 | 42.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 96 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 108 | 47.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 120 | 48.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 132 | 48.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 144 | 48.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 156 | 48.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 168 | 48.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 180 | 47.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 192 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | EOT | 39.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | EOS | 24.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 180 | 58.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 168 | 52.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 156 | 48.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 144 | 52.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 132 | 55.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 120 | 52.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 108 | 57.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 96 | 56.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 84 | 55.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 72 | 56.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 60 | 53.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 48 | 54.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 36 | 50.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 24 | 51.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 12 | 46.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | EOS | 33.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | EOT | 53.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 192 | 59.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 0 | 45.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-CRP Response Through Week 372 | Week 204 | 100.0 percentage of participants |
Secondary
Percentage of Participants With an ACR70-ESR Response Through Week 372
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 132 | 34.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 24 | 12.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 252 | 42.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 144 | 34.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | EOS | 17.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 240 | 41.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 156 | 37.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 228 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 168 | 37.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 28 | 16.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 216 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 180 | 36.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 32 | 17.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 360 | 37.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 192 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 36 | 22.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 204 | 44.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 2 | 4.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 348 | 27.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 40 | 20.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 44 | 19.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 48 | 22.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 4 | 5.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 336 | 35.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 60 | 21.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 8 | 7.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 324 | 43.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 72 | 25.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 12 | 10.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 312 | 43.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 84 | 27.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 0 | 2.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 300 | 35.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 96 | 28.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | EOT | 28.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 288 | 39.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 108 | 34.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 16 | 9.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 276 | 38.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 120 | 32.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 20 | 11.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 264 | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 0 | 36.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 12 | 36.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 24 | 36.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 36 | 38.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 48 | 38.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 60 | 41.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 72 | 38.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 84 | 40.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 96 | 39.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 108 | 42.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 120 | 43.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 132 | 39.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 144 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 156 | 47.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 168 | 45.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 180 | 47.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 192 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | EOT | 38.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | EOS | 20.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 168 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 156 | 46.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 144 | 49.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 132 | 53.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 120 | 49.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 108 | 52.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 96 | 52.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 84 | 51.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 72 | 51.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 60 | 50.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 48 | 50.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 36 | 44.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 24 | 47.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 12 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | EOS | 32.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | EOT | 50.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 0 | 41.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 192 | 59.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an ACR70-ESR Response Through Week 372 | Week 180 | 56.5 percentage of participants |
Secondary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT.
Time frame: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 204 | 83.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 168 | 77.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 372 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 216 | 80.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 240 | 78.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 252 | 78.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 264 | 75.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 276 | 81.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 288 | 76.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 300 | 76.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 312 | 81.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 324 | 82.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 336 | 75.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 348 | 70.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 360 | 87.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 180 | 79.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 36 | 68.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 228 | 80.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | EOT | 64.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 120 | 78.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 28 | 65.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 60 | 73.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 32 | 62.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 24 | 63.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 72 | 77.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 48 | 76.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 20 | 63.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 84 | 76.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 132 | 79.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 16 | 59.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 96 | 78.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 12 | 55.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 2 | 37.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 8 | 47.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 4 | 42.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 156 | 79.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 44 | 73.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 144 | 83.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 0 | 29.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 108 | 77.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | EOS | 52.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 192 | 82.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 40 | 70.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 48 | 83.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 96 | 85.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 120 | 84.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 132 | 81.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 144 | 85.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | EOT | 74.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 60 | 81.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 72 | 86.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 84 | 80.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 108 | 79.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 156 | 90.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 168 | 75.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 180 | 81.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 192 | 62.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | EOS | 69.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 0 | 82.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 12 | 81.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 24 | 85.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 36 | 83.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 168 | 93.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 156 | 93.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 144 | 91.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 108 | 91.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 96 | 90.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 132 | 91.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 12 | 85.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 84 | 89.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 72 | 90.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 60 | 89.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 120 | 91.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 24 | 89.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 48 | 90.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 192 | 95.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 0 | 86.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 204 | 100.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | EOT | 87.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 180 | 93.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | Week 36 | 91.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372 | EOS | 68.5 percentage of participants |
Secondary
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3.
Time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOS
Population: FAS population with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 24 | 13.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 264 | 35.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 144 | 27.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 2 | 5.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 252 | 31.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 156 | 24.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 372 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 240 | 37.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 168 | 28.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 28 | 15.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 228 | 37.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 180 | 27.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 32 | 16.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 216 | 33.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 192 | 33.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 36 | 16.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 204 | 30.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 4 | 6.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 360 | 31.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 40 | 12.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 44 | 16.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 48 | 18.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 8 | 5.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 348 | 22.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 60 | 14.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 12 | 6.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 336 | 28.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 72 | 21.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | EOS | 13.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 324 | 34.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 84 | 21.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 0 | 4.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 312 | 32.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 96 | 24.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | EOT | 23.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 300 | 33.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 108 | 25.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 16 | 8.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 288 | 38.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 120 | 24.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 20 | 10.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 276 | 32.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ1 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 132 | 28.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 84 | 35.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 0 | 24.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 12 | 27.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 24 | 28.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 36 | 31.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 48 | 32.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 60 | 30.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 72 | 37.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 96 | 37.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 108 | 39.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 120 | 40.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 132 | 41.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 144 | 41.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 156 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 168 | 51.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 180 | 42.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 192 | 25.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 204 | 0.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | EOT | 36.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ3 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | EOS | 13.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 180 | 45.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 168 | 44.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 156 | 42.5 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 144 | 45.2 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 132 | 44.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 120 | 38.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 108 | 42.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 96 | 42.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 84 | 42.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 72 | 43.3 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 60 | 41.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 48 | 42.8 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 36 | 40.9 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 24 | 37.1 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 12 | 31.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | EOS | 24.7 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | EOT | 43.4 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 192 | 50.0 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 0 | 32.6 percentage of participants |
| Participants Who Completed 015K-CL-RAJ4 | Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372 | Week 204 | 100.0 percentage of participants |