Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of ASP015K in Patients With Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate (MTX) Treatment (NCT NCT02305849)

NCT ID: NCT02305849

Last Updated: 2024-10-28

Results Overview

ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 519 participants
• Primary outcome timeframe: Baseline and week 12/Early termination (ET)
• Results posted on: 2024-10-28

Participant Flow

Participants with rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX) were enrolled in this study.

Participants were randomized in a 1:1:1 ratio to peficitinib 100 milligram (mg), 150 mg or placebo groups in combination with MTX at baseline. At week 12 or 28, participants in the placebo group were switched to receive either peficitinib at a dose of 100 mg or 150 mg, which was determined in advance randomly.

Participant milestones

Measure	Peficitinib 100 mg Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 100 mg Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Placebo / Peficitinib 150 mg Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
Overall Study STARTED	175	174	85	85
Overall Study COMPLETED	148	146	67	66
Overall Study NOT COMPLETED	27	28	18	19

Reasons for withdrawal

Measure	Peficitinib 100 mg Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 100 mg Participants who received placebo matching to peficitinib 100 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Placebo / Peficitinib 150 mg Participants who received placebo matching to peficitinib 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.
Overall Study Adverse Event	10	12	7	3
Overall Study Lack of Efficacy	10	6	3	9
Overall Study Withdrawal by Subject	2	2	1	4
Overall Study Lost to Follow-up	0	2	0	0
Overall Study Protocol Violation	3	2	1	1
Overall Study Lab data met discontinuation criteria	0	1	2	1
Overall Study Miscellaneous	1	2	4	1
Overall Study Not fulfill eligibility criteria	1	1	0	0

Baseline Characteristics

Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug. Here, Number of participants analyzed signifies participants with available data.

Baseline characteristics by cohort

Measure	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=174 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo n=170 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Total n=518 Participants Total of all reporting groups
Age, Continuous	58.5 Years STANDARD_DEVIATION 10.8 • n=174 Participants	56.2 Years STANDARD_DEVIATION 11.6 • n=174 Participants	55.3 Years STANDARD_DEVIATION 12.1 • n=170 Participants	56.7 Years STANDARD_DEVIATION 11.6 • n=518 Participants
Sex: Female, Male Female	118 Participants n=174 Participants	125 Participants n=174 Participants	121 Participants n=170 Participants	364 Participants n=518 Participants
Sex: Female, Male Male	56 Participants n=174 Participants	49 Participants n=174 Participants	49 Participants n=170 Participants	154 Participants n=518 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=174 Participants	0 Participants n=170 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Asian	174 Participants n=174 Participants	174 Participants n=174 Participants	170 Participants n=170 Participants	518 Participants n=518 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=174 Participants	0 Participants n=170 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Black or African American	0 Participants n=174 Participants	0 Participants n=174 Participants	0 Participants n=170 Participants	0 Participants n=518 Participants
Race (NIH/OMB) White	0 Participants n=174 Participants	0 Participants n=174 Participants	0 Participants n=170 Participants	0 Participants n=518 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants	0 Participants n=174 Participants	0 Participants n=170 Participants	0 Participants n=518 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	0 Participants n=174 Participants	0 Participants n=170 Participants	0 Participants n=518 Participants
C-Reactive Protein (CRP)	2.432 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.076 • n=174 Participants • Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug. Here, Number of participants analyzed signifies participants with available data.	2.524 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.183 • n=174 Participants • Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug. Here, Number of participants analyzed signifies participants with available data.	2.622 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.146 • n=169 Participants • Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug. Here, Number of participants analyzed signifies participants with available data.	2.525 milligram/deciliter (mg/dL) STANDARD_DEVIATION 2.132 • n=517 Participants • Full analysis set (FAS) included all participants who were randomized and received at least one dose of the study drug. Here, Number of participants analyzed signifies participants with available data.
Erosion Score	10.34 units on a scale STANDARD_DEVIATION 17.47 • n=173 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	9.76 units on a scale STANDARD_DEVIATION 15.93 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	11.03 units on a scale STANDARD_DEVIATION 17.96 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	10.37 units on a scale STANDARD_DEVIATION 17.11 • n=516 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Erythrocyte Sedimentation Rate (ESR)	50.4 millimeter per hour (mm/h) STANDARD_DEVIATION 26.2 • n=174 Participants • FAS.	51.5 millimeter per hour (mm/h) STANDARD_DEVIATION 26.8 • n=174 Participants • FAS.	53.8 millimeter per hour (mm/h) STANDARD_DEVIATION 26.9 • n=170 Participants • FAS.	51.9 millimeter per hour (mm/h) STANDARD_DEVIATION 26.6 • n=518 Participants • FAS.
Health Assessment Questionnaire - Disability Index (HAQ-DI)	0.91 units on a scale STANDARD_DEVIATION 0.65 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	1.02 units on a scale STANDARD_DEVIATION 0.62 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	1.05 units on a scale STANDARD_DEVIATION 0.66 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	0.99 units on a scale STANDARD_DEVIATION 0.65 • n=517 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Joint Space Narrowing (JSN) Score	14.89 units on a scale STANDARD_DEVIATION 19.47 • n=173 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	15.23 units on a scale STANDARD_DEVIATION 18.33 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	17.37 units on a scale STANDARD_DEVIATION 20.13 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	15.82 units on a scale STANDARD_DEVIATION 19.31 • n=516 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Modified Total Sharp Score (mTSS)	25.23 units on a scale STANDARD_DEVIATION 35.5 • n=173 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	25 units on a scale STANDARD_DEVIATION 32.38 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	28.4 units on a scale STANDARD_DEVIATION 36.28 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	26.19 units on a scale STANDARD_DEVIATION 34.71 • n=516 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Physician's Global Assessment of Arthritis (PGA)	58.87 units on a scale STANDARD_DEVIATION 19.67 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	60.86 units on a scale STANDARD_DEVIATION 19.09 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	60.98 units on a scale STANDARD_DEVIATION 19.59 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	60.23 units on a scale STANDARD_DEVIATION 19.43 • n=517 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Subject's Global Assessment of Arthritis (SGA)	51.7 units on a scale STANDARD_DEVIATION 25.25 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	55.44 units on a scale STANDARD_DEVIATION 24.49 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	58.18 units on a scale STANDARD_DEVIATION 23.9 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	55.07 units on a scale STANDARD_DEVIATION 24.65 • n=517 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Subject's Global Assessment of Arthritis Pain (SGAP)	51.12 units on a scale STANDARD_DEVIATION 26.14 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	55.09 units on a scale STANDARD_DEVIATION 24.89 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	56.75 units on a scale STANDARD_DEVIATION 25.29 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	54.3 units on a scale STANDARD_DEVIATION 25.51 • n=517 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.
Swollen Joint Count (SJC) (66 Joints)	12.8 swollen joint count STANDARD_DEVIATION 6.8 • n=174 Participants • FAS.	13.1 swollen joint count STANDARD_DEVIATION 6.9 • n=174 Participants • FAS.	13.6 swollen joint count STANDARD_DEVIATION 7 • n=170 Participants • FAS.	13.2 swollen joint count STANDARD_DEVIATION 6.9 • n=518 Participants • FAS.
Tender Joint Count (TJC) (68 Joints)	14 tender joint count STANDARD_DEVIATION 8.6 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	14.5 tender joint count STANDARD_DEVIATION 7.8 • n=174 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	15.4 tender joint count STANDARD_DEVIATION 9.4 • n=169 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.	14.6 tender joint count STANDARD_DEVIATION 8.6 • n=517 Participants • FAS. Here, Number of participants analyzed signifies participants with available data.

PRIMARY outcome

Timeframe: Baseline and week 12/Early termination (ET)

Population: FAS. Last observation carried forward (LOCF) was used for missing imputations.

ACR20 response: greater than and equal to (≥) 20 percent (%) improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 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.

Outcome measures

Measure	Placebo n=170 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=174 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12	21.8 percentage of participants	58.6 percentage of participants	64.4 percentage of participants	—	—	—

PRIMARY outcome

Timeframe: Baseline and week 28/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 28 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Measure	Placebo n=153 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=164 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=164 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in mTSS at Week 28	3.37 units on a scale Standard Deviation 5.46	1.62 units on a scale Standard Deviation 4.23	1.03 units on a scale Standard Deviation 2.86	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, number of participants analyzed signifies participants with available data.

ACR20 response:≥ 20% improvement in tender and swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria compared with baseline: 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 or week 52.

Outcome measures

Measure	Placebo n=174 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=38 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With an ACR20-CRP Response Through Week 52 EOT	76.4 percentage of participants	81.0 percentage of participants	73.0 percentage of participants	78.9 percentage of participants	92.3 percentage of participants	91.2 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 4	38.2 percentage of participants	48.2 percentage of participants	8.1 percentage of participants	2.7 percentage of participants	38.5 percentage of participants	14.7 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 52	84.8 percentage of participants	87.1 percentage of participants	75.8 percentage of participants	90.9 percentage of participants	91.2 percentage of participants	90.9 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 8	51.2 percentage of participants	62.0 percentage of participants	10.8 percentage of participants	0.0 percentage of participants	33.3 percentage of participants	29.4 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 12	59.5 percentage of participants	66.3 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	51.3 percentage of participants	38.2 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 16	70.5 percentage of participants	77.0 percentage of participants	43.2 percentage of participants	51.4 percentage of participants	64.1 percentage of participants	58.8 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 20	74.4 percentage of participants	79.8 percentage of participants	59.5 percentage of participants	67.6 percentage of participants	61.5 percentage of participants	61.8 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 48	83.8 percentage of participants	89.4 percentage of participants	81.8 percentage of participants	90.9 percentage of participants	85.7 percentage of participants	90.9 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 24	74.5 percentage of participants	85.0 percentage of participants	63.9 percentage of participants	80.6 percentage of participants	59.0 percentage of participants	52.9 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 28	79.1 percentage of participants	83.0 percentage of participants	72.2 percentage of participants	83.3 percentage of participants	64.1 percentage of participants	64.7 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 32	79.6 percentage of participants	85.2 percentage of participants	77.8 percentage of participants	86.1 percentage of participants	84.6 percentage of participants	76.5 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 36	78.4 percentage of participants	86.5 percentage of participants	80.6 percentage of participants	85.7 percentage of participants	78.4 percentage of participants	75.8 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 40	80.9 percentage of participants	86.9 percentage of participants	80.0 percentage of participants	88.2 percentage of participants	88.9 percentage of participants	78.8 percentage of participants
Percentage of Participants With an ACR20-CRP Response Through Week 52 Week 44	79.9 percentage of participants	86.9 percentage of participants	76.5 percentage of participants	90.9 percentage of participants	88.9 percentage of participants	87.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. LOCF was used for missing imputations.

ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 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.

Outcome measures

Measure	Placebo n=170 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=174 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With an ACR50-CRP Response at Week 12	7.6 percentage of participants	29.9 percentage of participants	46.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

ACR50 response: ≥50% improvement in tender and swollen joint counts and 50% improvement in 3 of the following 5 criteria compared with baseline: 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.

Outcome measures

Measure	Placebo n=174 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=38 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 32	59.2 percentage of participants	65.8 percentage of participants	52.8 percentage of participants	61.1 percentage of participants	56.4 percentage of participants	52.9 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 4	10.0 percentage of participants	15.9 percentage of participants	2.7 percentage of participants	0.0 percentage of participants	10.3 percentage of participants	0.0 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 8	19.6 percentage of participants	33.1 percentage of participants	2.7 percentage of participants	0.0 percentage of participants	12.8 percentage of participants	2.9 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 12	29.8 percentage of participants	48.2 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	23.1 percentage of participants	5.9 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 16	46.4 percentage of participants	53.9 percentage of participants	13.5 percentage of participants	21.6 percentage of participants	38.5 percentage of participants	8.8 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 20	51.2 percentage of participants	54.6 percentage of participants	35.1 percentage of participants	37.8 percentage of participants	35.9 percentage of participants	29.4 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 24	56.5 percentage of participants	60.6 percentage of participants	47.2 percentage of participants	52.8 percentage of participants	33.3 percentage of participants	29.4 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 28	53.8 percentage of participants	63.5 percentage of participants	50.0 percentage of participants	69.4 percentage of participants	28.2 percentage of participants	23.5 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 36	55.6 percentage of participants	67.7 percentage of participants	58.3 percentage of participants	71.4 percentage of participants	64.9 percentage of participants	60.6 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 40	61.8 percentage of participants	68.0 percentage of participants	48.6 percentage of participants	67.6 percentage of participants	66.7 percentage of participants	66.7 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 44	57.7 percentage of participants	71.2 percentage of participants	52.9 percentage of participants	72.7 percentage of participants	72.2 percentage of participants	63.6 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 48	60.8 percentage of participants	64.9 percentage of participants	60.6 percentage of participants	69.7 percentage of participants	71.4 percentage of participants	66.7 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 Week 52	66.9 percentage of participants	68.0 percentage of participants	63.6 percentage of participants	63.6 percentage of participants	67.6 percentage of participants	69.7 percentage of participants
Percentage of Participants With an ACR50-CRP Response Through Week 52 EOT	60.3 percentage of participants	62.6 percentage of participants	62.2 percentage of participants	55.3 percentage of participants	69.2 percentage of participants	70.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. LOCF was used for missing imputations.

ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 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.

Outcome measures

Measure	Placebo n=170 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=174 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With an ACR70-CRP Response at Week 12	2.4 percentage of participants	12.1 percentage of participants	23.6 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

ACR70 response: ≥ 70% improvement in tender and swollen joint counts and 70% improvement in 3 of the following 5 criteria compared with baseline: 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.

Outcome measures

Measure	Placebo n=174 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=38 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 16	24.1 percentage of participants	32.1 percentage of participants	5.4 percentage of participants	2.7 percentage of participants	12.8 percentage of participants	2.9 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 32	36.3 percentage of participants	43.9 percentage of participants	33.3 percentage of participants	44.4 percentage of participants	20.5 percentage of participants	20.6 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 44	38.3 percentage of participants	48.4 percentage of participants	41.2 percentage of participants	36.4 percentage of participants	38.9 percentage of participants	39.4 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 48	33.8 percentage of participants	49.0 percentage of participants	45.5 percentage of participants	42.4 percentage of participants	45.7 percentage of participants	39.4 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 4	1.2 percentage of participants	4.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	2.6 percentage of participants	0.0 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 8	7.7 percentage of participants	13.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	2.6 percentage of participants	0.0 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 12	12.5 percentage of participants	24.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	7.7 percentage of participants	2.9 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 20	26.2 percentage of participants	35.0 percentage of participants	8.1 percentage of participants	2.7 percentage of participants	12.8 percentage of participants	2.9 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 24	31.7 percentage of participants	36.0 percentage of participants	22.2 percentage of participants	16.7 percentage of participants	17.9 percentage of participants	2.9 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 28	29.1 percentage of participants	42.8 percentage of participants	33.3 percentage of participants	38.9 percentage of participants	17.9 percentage of participants	8.8 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 36	34.0 percentage of participants	47.1 percentage of participants	33.3 percentage of participants	42.9 percentage of participants	13.5 percentage of participants	33.3 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 40	34.9 percentage of participants	41.8 percentage of participants	31.4 percentage of participants	38.2 percentage of participants	36.1 percentage of participants	33.3 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 Week 52	39.3 percentage of participants	52.4 percentage of participants	42.4 percentage of participants	48.5 percentage of participants	44.1 percentage of participants	48.5 percentage of participants
Percentage of Participants With an ACR70-CRP Response Through Week 52 EOT	35.1 percentage of participants	48.3 percentage of participants	40.5 percentage of participants	42.1 percentage of participants	43.6 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and week 52/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change from baseline was calculated as score at week 52 (ET) minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Measure	Placebo n=153 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=164 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=164 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in mTSS at Week 52	6.27 units on a scale Standard Deviation 10.18	2.12 units on a scale Standard Deviation 5.83	1.54 units on a scale Standard Deviation 4.11	—	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 28/ET and 52/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.

JSN was defined as narrowing in joint space width over the course of the study. The JSN score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. JSN, including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. Higher scores indicate greater disease activity.

Outcome measures

Measure	Placebo n=153 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=164 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=164 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in JSN Score at Week 28 and Week 52 Week 28/ET	1.90 units on a scale Standard Deviation 3.76	0.99 units on a scale Standard Deviation 2.86	0.82 units on a scale Standard Deviation 2.39	—	—	—
Change From Baseline in JSN Score at Week 28 and Week 52 Week 52/ET	3.55 units on a scale Standard Deviation 7.01	1.30 units on a scale Standard Deviation 3.37	1.19 units on a scale Standard Deviation 3.03	—	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 28/ET and 52/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.

The joint erosion score was a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint in the hand is scored from 0-5 and each joint in the foot is scored from 0-10. The score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet. By summing these score, the range of total erosion score is 0-280. Higher erosion score indicates greater disease activity.

Outcome measures

Measure	Placebo n=153 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=164 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=164 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in Erosion Score at Week 28 and Week 52 Week 28/ET	1.35 units on a scale Standard Deviation 3.01	0.63 units on a scale Standard Deviation 2.03	0.18 units on a scale Standard Deviation 1.10	—	—	—
Change From Baseline in Erosion Score at Week 28 and Week 52 Week 52/ET	2.52 units on a scale Standard Deviation 5.58	0.82 units on a scale Standard Deviation 3.14	0.32 units on a scale Standard Deviation 1.87	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 28/ET and 52/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Missing values were imputed by linear extrapolation.

mTSS was defined as the sum of joint erosion scores graded by assessing erosion severity in 44 joints (16 per hand and 6 per feet) and JSN scores graded by assessing narrowing of joint spaces in 42 joints (15 per hand and 6 per feet). Erosion score was scored from 0 (no erosion) to 5 (complete collapse of bone) and the score for erosion ranges from 0 to 160 in the hands and from 0 to 120 in the feet (the maximum erosion score for a joint in the foot is 10). JSN including subluxation, was scored from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. mTSS scores ranged from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

Outcome measures

Measure	Placebo n=153 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=164 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=164 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 Week 28/ET	45.8 percentage of participants	67.1 percentage of participants	72.6 percentage of participants	—	—	—
Percentage of Participants Achieving Change From Baseline in mTSS <= 0.5 at Week 28 and Week 52 Week 52/ET	42.5 percentage of participants	64.0 percentage of participants	68.9 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12	-0.51 units on a scale Standard Deviation 1.10	-1.70 units on a scale Standard Deviation 1.20	-2.09 units on a scale Standard Deviation 1.33	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=37 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in DAS28-CRP Through Week 52 Week 4	-1.11 units on a scale Standard Deviation 0.81	-1.39 units on a scale Standard Deviation 0.98	-0.28 units on a scale Standard Deviation 0.67	-0.30 units on a scale Standard Deviation 0.56	-0.82 units on a scale Standard Deviation 1.09	-0.74 units on a scale Standard Deviation 0.62
Change From Baseline in DAS28-CRP Through Week 52 Week 20	-2.21 units on a scale Standard Deviation 1.24	-2.53 units on a scale Standard Deviation 1.29	-1.69 units on a scale Standard Deviation 1.22	-1.76 units on a scale Standard Deviation 1.24	-1.38 units on a scale Standard Deviation 1.19	-1.48 units on a scale Standard Deviation 0.78
Change From Baseline in DAS28-CRP Through Week 52 Week 24	-2.40 units on a scale Standard Deviation 1.21	-2.71 units on a scale Standard Deviation 1.18	-2.01 units on a scale Standard Deviation 1.26	-2.26 units on a scale Standard Deviation 1.07	-1.41 units on a scale Standard Deviation 1.32	-1.64 units on a scale Standard Deviation 0.92
Change From Baseline in DAS28-CRP Through Week 52 Week 32	-2.50 units on a scale Standard Deviation 1.18	-2.77 units on a scale Standard Deviation 1.19	-2.49 units on a scale Standard Deviation 1.24	-2.72 units on a scale Standard Deviation 1.27	-2.18 units on a scale Standard Deviation 1.27	-2.47 units on a scale Standard Deviation 0.89
Change From Baseline in DAS28-CRP Through Week 52 Week 8	-1.48 units on a scale Standard Deviation 1.00	-1.87 units on a scale Standard Deviation 1.16	-0.21 units on a scale Standard Deviation 0.86	-0.10 units on a scale Standard Deviation 0.63	-0.94 units on a scale Standard Deviation 0.97	-0.90 units on a scale Standard Deviation 0.65
Change From Baseline in DAS28-CRP Through Week 52 Week 12	-1.72 units on a scale Standard Deviation 1.19	-2.15 units on a scale Standard Deviation 1.29	0.24 units on a scale Standard Deviation 0.75	0.27 units on a scale Standard Deviation 0.60	-1.34 units on a scale Standard Deviation 1.00	-1.20 units on a scale Standard Deviation 0.66
Change From Baseline in DAS28-CRP Through Week 52 Week 16	-2.01 units on a scale Standard Deviation 1.18	-2.40 units on a scale Standard Deviation 1.30	-1.11 units on a scale Standard Deviation 1.15	-1.37 units on a scale Standard Deviation 1.18	-1.37 units on a scale Standard Deviation 1.35	-1.31 units on a scale Standard Deviation 0.74
Change From Baseline in DAS28-CRP Through Week 52 Week 28	-2.42 units on a scale Standard Deviation 1.21	-2.70 units on a scale Standard Deviation 1.25	-2.24 units on a scale Standard Deviation 1.11	-2.51 units on a scale Standard Deviation 1.13	-1.53 units on a scale Standard Deviation 1.39	-1.71 units on a scale Standard Deviation 0.97
Change From Baseline in DAS28-CRP Through Week 52 Week 36	-2.55 units on a scale Standard Deviation 1.12	-2.83 units on a scale Standard Deviation 1.20	-2.49 units on a scale Standard Deviation 1.14	-2.70 units on a scale Standard Deviation 1.22	-2.22 units on a scale Standard Deviation 1.23	-2.57 units on a scale Standard Deviation 0.89
Change From Baseline in DAS28-CRP Through Week 52 Week 40	-2.66 units on a scale Standard Deviation 1.16	-2.86 units on a scale Standard Deviation 1.14	-2.66 units on a scale Standard Deviation 1.24	-2.72 units on a scale Standard Deviation 1.13	-2.62 units on a scale Standard Deviation 1.05	-2.73 units on a scale Standard Deviation 0.93
Change From Baseline in DAS28-CRP Through Week 52 Week 44	-2.65 units on a scale Standard Deviation 1.13	-2.88 units on a scale Standard Deviation 1.15	-2.68 units on a scale Standard Deviation 1.23	-2.72 units on a scale Standard Deviation 1.19	-2.63 units on a scale Standard Deviation 1.35	-2.87 units on a scale Standard Deviation 0.89
Change From Baseline in DAS28-CRP Through Week 52 Week 48	-2.62 units on a scale Standard Deviation 1.15	-2.92 units on a scale Standard Deviation 1.14	-2.86 units on a scale Standard Deviation 1.26	-2.90 units on a scale Standard Deviation 1.18	-2.66 units on a scale Standard Deviation 1.49	-2.96 units on a scale Standard Deviation 0.97
Change From Baseline in DAS28-CRP Through Week 52 Week 52	-2.67 units on a scale Standard Deviation 1.19	-2.96 units on a scale Standard Deviation 1.24	-2.80 units on a scale Standard Deviation 1.46	-2.74 units on a scale Standard Deviation 1.13	-2.70 units on a scale Standard Deviation 1.32	-2.89 units on a scale Standard Deviation 0.92
Change From Baseline in DAS28-CRP Through Week 52 EOT	-2.43 units on a scale Standard Deviation 1.37	-2.76 units on a scale Standard Deviation 1.40	-2.61 units on a scale Standard Deviation 1.62	-2.52 units on a scale Standard Deviation 1.25	-2.72 units on a scale Standard Deviation 1.26	-2.87 units on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=170 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in DAS28-ESR at Week 12	-0.51 units on a scale Standard Deviation 1.11	-1.66 units on a scale Standard Deviation 1.22	-2.12 units on a scale Standard Deviation 1.36	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=170 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=37 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in DAS28-ESR Score Through Week 52 Week 4	-1.07 units on a scale Standard Deviation 0.83	-1.37 units on a scale Standard Deviation 1.02	-0.26 units on a scale Standard Deviation 0.66	-0.26 units on a scale Standard Deviation 0.59	-0.87 units on a scale Standard Deviation 1.08	-0.67 units on a scale Standard Deviation 0.64
Change From Baseline in DAS28-ESR Score Through Week 52 Week 28	-2.47 units on a scale Standard Deviation 1.31	-2.79 units on a scale Standard Deviation 1.29	-2.11 units on a scale Standard Deviation 1.16	-2.48 units on a scale Standard Deviation 1.15	-1.63 units on a scale Standard Deviation 1.41	-1.62 units on a scale Standard Deviation 1.07
Change From Baseline in DAS28-ESR Score Through Week 52 Week 52	-2.70 units on a scale Standard Deviation 1.27	-3.07 units on a scale Standard Deviation 1.28	-2.77 units on a scale Standard Deviation 1.54	-2.78 units on a scale Standard Deviation 1.24	-2.79 units on a scale Standard Deviation 1.33	-2.85 units on a scale Standard Deviation 1.08
Change From Baseline in DAS28-ESR Score Through Week 52 EOT	-2.47 units on a scale Standard Deviation 1.43	-2.86 units on a scale Standard Deviation 1.44	-2.60 units on a scale Standard Deviation 1.69	-2.56 units on a scale Standard Deviation 1.34	-2.80 units on a scale Standard Deviation 1.27	-2.82 units on a scale Standard Deviation 1.08
Change From Baseline in DAS28-ESR Score Through Week 52 Week 8	-1.47 units on a scale Standard Deviation 1.06	-1.88 units on a scale Standard Deviation 1.18	-0.24 units on a scale Standard Deviation 0.88	-0.12 units on a scale Standard Deviation 0.64	-1.00 units on a scale Standard Deviation 0.93	-0.85 units on a scale Standard Deviation 0.76
Change From Baseline in DAS28-ESR Score Through Week 52 Week 12	-1.68 units on a scale Standard Deviation 1.21	-2.18 units on a scale Standard Deviation 1.32	0.24 units on a scale Standard Deviation 0.76	0.25 units on a scale Standard Deviation 0.59	-1.40 units on a scale Standard Deviation 0.99	-1.10 units on a scale Standard Deviation 0.76
Change From Baseline in DAS28-ESR Score Through Week 52 Week 16	-1.98 units on a scale Standard Deviation 1.22	-2.46 units on a scale Standard Deviation 1.32	-1.01 units on a scale Standard Deviation 1.14	-1.38 units on a scale Standard Deviation 1.21	-1.47 units on a scale Standard Deviation 1.39	-1.21 units on a scale Standard Deviation 0.82
Change From Baseline in DAS28-ESR Score Through Week 52 Week 20	-2.23 units on a scale Standard Deviation 1.27	-2.60 units on a scale Standard Deviation 1.35	-1.61 units on a scale Standard Deviation 1.23	-1.78 units on a scale Standard Deviation 1.26	-1.45 units on a scale Standard Deviation 1.19	-1.37 units on a scale Standard Deviation 0.81
Change From Baseline in DAS28-ESR Score Through Week 52 Week 24	-2.43 units on a scale Standard Deviation 1.28	-2.78 units on a scale Standard Deviation 1.25	-1.94 units on a scale Standard Deviation 1.24	-2.24 units on a scale Standard Deviation 1.16	-1.47 units on a scale Standard Deviation 1.31	-1.56 units on a scale Standard Deviation 0.99
Change From Baseline in DAS28-ESR Score Through Week 52 Week 32	-2.56 units on a scale Standard Deviation 1.31	-2.87 units on a scale Standard Deviation 1.27	-2.39 units on a scale Standard Deviation 1.26	-2.68 units on a scale Standard Deviation 1.30	-2.27 units on a scale Standard Deviation 1.34	-2.37 units on a scale Standard Deviation 1.05
Change From Baseline in DAS28-ESR Score Through Week 52 Week 36	-2.59 units on a scale Standard Deviation 1.23	-2.91 units on a scale Standard Deviation 1.25	-2.45 units on a scale Standard Deviation 1.20	-2.71 units on a scale Standard Deviation 1.20	-2.38 units on a scale Standard Deviation 1.29	-2.54 units on a scale Standard Deviation 1.02
Change From Baseline in DAS28-ESR Score Through Week 52 Week 40	-2.70 units on a scale Standard Deviation 1.22	-2.96 units on a scale Standard Deviation 1.20	-2.60 units on a scale Standard Deviation 1.34	-2.78 units on a scale Standard Deviation 1.11	-2.71 units on a scale Standard Deviation 1.16	-2.68 units on a scale Standard Deviation 0.96
Change From Baseline in DAS28-ESR Score Through Week 52 Week 44	-2.71 units on a scale Standard Deviation 1.19	-3.00 units on a scale Standard Deviation 1.25	-2.63 units on a scale Standard Deviation 1.25	-2.76 units on a scale Standard Deviation 1.25	-2.74 units on a scale Standard Deviation 1.43	-2.78 units on a scale Standard Deviation 1.04
Change From Baseline in DAS28-ESR Score Through Week 52 Week 48	-2.64 units on a scale Standard Deviation 1.20	-3.01 units on a scale Standard Deviation 1.22	-2.80 units on a scale Standard Deviation 1.36	-2.88 units on a scale Standard Deviation 1.23	-2.72 units on a scale Standard Deviation 1.58	-2.93 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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), 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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in TJC (68 Joints) at Week 12	-2.1 tender joint count Standard Deviation 8.2	-6.9 tender joint count Standard Deviation 8.6	-9.1 tender joint count Standard Deviation 8.0	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100mg and 150 mg arms are analyzed for this outcome measure, as planned.

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), 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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in TJC (68 Joints) Through Week 52 Week 40	-10.8 tender joint count Standard Deviation 7.2	-11.9 tender joint count Standard Deviation 8.2	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 EOT	-9.8 tender joint count Standard Deviation 7.8	-11.2 tender joint count Standard Deviation 8.8	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 8	-6.8 tender joint count Standard Deviation 7.2	-8.3 tender joint count Standard Deviation 7.3	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 12	-7.1 tender joint count Standard Deviation 8.6	-9.3 tender joint count Standard Deviation 7.7	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 16	-8.1 tender joint count Standard Deviation 7.8	-10.5 tender joint count Standard Deviation 7.4	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 20	-9.1 tender joint count Standard Deviation 7.9	-10.8 tender joint count Standard Deviation 8.0	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 24	-9.9 tender joint count Standard Deviation 7.5	-11.3 tender joint count Standard Deviation 7.6	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 28	-9.6 tender joint count Standard Deviation 7.4	-11.4 tender joint count Standard Deviation 7.8	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 32	-9.7 tender joint count Standard Deviation 7.2	-12.1 tender joint count Standard Deviation 7.6	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 36	-10.4 tender joint count Standard Deviation 7.6	-11.8 tender joint count Standard Deviation 7.7	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 4	-5.1 tender joint count Standard Deviation 5.8	-6.3 tender joint count Standard Deviation 6.9	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 44	-10.6 tender joint count Standard Deviation 7.4	-12.1 tender joint count Standard Deviation 7.8	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 48	-10.5 tender joint count Standard Deviation 7.1	-12.1 tender joint count Standard Deviation 7.7	—	—	—	—
Change From Baseline in TJC (68 Joints) Through Week 52 Week 52	-10.8 tender joint count Standard Deviation 7.4	-11.9 tender joint count Standard Deviation 8.6	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SJC (66 Joints) at Week 12	-2.2 swollen joint count Standard Deviation 6.6	-5.9 swollen joint count Standard Deviation 6.7	-7.6 swollen joint count Standard Deviation 6.1	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SJC (66 Joints) Through Week 52 Week 24	-8.8 swollen joint count Standard Deviation 6.4	-9.9 swollen joint count Standard Deviation 5.6	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 32	-9.0 swollen joint count Standard Deviation 6.2	-10.3 swollen joint count Standard Deviation 5.8	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 36	-9.0 swollen joint count Standard Deviation 6.1	-10.5 swollen joint count Standard Deviation 5.9	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 40	-9.4 swollen joint count Standard Deviation 6.1	-10.7 swollen joint count Standard Deviation 6.1	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 44	-9.4 swollen joint count Standard Deviation 6.1	-10.8 swollen joint count Standard Deviation 6.4	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 52	-9.6 swollen joint count Standard Deviation 6.2	-11.0 swollen joint count Standard Deviation 6.1	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 EOT	-8.8 swollen joint count Standard Deviation 6.6	-10.3 swollen joint count Standard Deviation 6.4	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 4	-4.3 swollen joint count Standard Deviation 4.5	-5.3 swollen joint count Standard Deviation 5.6	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 8	-5.6 swollen joint count Standard Deviation 5.5	-7.1 swollen joint count Standard Deviation 5.5	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 12	-6.0 swollen joint count Standard Deviation 6.7	-7.8 swollen joint count Standard Deviation 5.9	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 16	-7.5 swollen joint count Standard Deviation 6.2	-8.9 swollen joint count Standard Deviation 6.0	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 20	-8.1 swollen joint count Standard Deviation 6.1	-9.2 swollen joint count Standard Deviation 5.7	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 28	-8.8 swollen joint count Standard Deviation 6.2	-9.8 swollen joint count Standard Deviation 5.7	—	—	—	—
Change From Baseline in SJC (66 Joints) Through Week 52 Week 48	-9.2 swollen joint count Standard Deviation 6.2	-11.0 swollen joint count Standard Deviation 6.3	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-CRP Score < 2.6 at Week 12	7.7 percentage of participants	31.4 percentage of participants	35.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=38 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 16	39.2 percentage of participants	43.0 percentage of participants	8.1 percentage of participants	13.5 percentage of participants	20.5 percentage of participants	8.8 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 24	51.6 percentage of participants	56.9 percentage of participants	27.8 percentage of participants	33.3 percentage of participants	20.5 percentage of participants	32.4 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 52	60.0 percentage of participants	62.6 percentage of participants	54.5 percentage of participants	39.4 percentage of participants	55.9 percentage of participants	63.6 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 4	11.2 percentage of participants	14.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	15.4 percentage of participants	5.9 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 8	19.0 percentage of participants	21.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	10.3 percentage of participants	11.8 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 12	31.0 percentage of participants	36.1 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	20.5 percentage of participants	11.8 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 20	45.7 percentage of participants	52.1 percentage of participants	21.6 percentage of participants	16.2 percentage of participants	17.9 percentage of participants	29.4 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 28	51.9 percentage of participants	52.8 percentage of participants	30.6 percentage of participants	38.9 percentage of participants	25.6 percentage of participants	26.5 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 32	54.1 percentage of participants	52.9 percentage of participants	44.4 percentage of participants	50.0 percentage of participants	30.8 percentage of participants	44.1 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 36	53.6 percentage of participants	53.5 percentage of participants	50.0 percentage of participants	48.6 percentage of participants	35.1 percentage of participants	54.5 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 40	59.9 percentage of participants	58.8 percentage of participants	42.9 percentage of participants	50.0 percentage of participants	61.1 percentage of participants	54.5 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 44	57.0 percentage of participants	55.6 percentage of participants	50.0 percentage of participants	42.4 percentage of participants	55.6 percentage of participants	57.6 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 Week 48	56.1 percentage of participants	60.3 percentage of participants	54.5 percentage of participants	54.5 percentage of participants	62.9 percentage of participants	66.7 percentage of participants
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 52 EOT	56.4 percentage of participants	57.9 percentage of participants	54.1 percentage of participants	34.2 percentage of participants	56.4 percentage of participants	64.7 percentage of participants

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-ESR Score < 2.6 at Week 12	2.4 percentage of participants	12.8 percentage of participants	19.3 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data.

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. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=37 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=38 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 4	4.1 percentage of participants	5.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	2.6 percentage of participants	0.0 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 8	8.9 percentage of participants	12.7 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	2.6 percentage of participants	2.9 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 12	13.1 percentage of participants	19.9 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	5.1 percentage of participants	5.9 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 16	18.1 percentage of participants	24.2 percentage of participants	0.0 percentage of participants	10.8 percentage of participants	10.3 percentage of participants	2.9 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 20	22.6 percentage of participants	33.1 percentage of participants	5.4 percentage of participants	10.8 percentage of participants	7.7 percentage of participants	5.9 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 24	28.0 percentage of participants	31.3 percentage of participants	5.6 percentage of participants	27.8 percentage of participants	12.8 percentage of participants	5.9 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 28	30.4 percentage of participants	32.1 percentage of participants	11.1 percentage of participants	22.2 percentage of participants	12.8 percentage of participants	8.8 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 32	33.8 percentage of participants	41.3 percentage of participants	22.2 percentage of participants	30.6 percentage of participants	15.4 percentage of participants	26.5 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 36	32.7 percentage of participants	40.0 percentage of participants	13.9 percentage of participants	37.1 percentage of participants	13.5 percentage of participants	24.2 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 40	37.1 percentage of participants	36.2 percentage of participants	20.0 percentage of participants	35.3 percentage of participants	22.2 percentage of participants	30.3 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 44	34.0 percentage of participants	37.3 percentage of participants	17.6 percentage of participants	24.2 percentage of participants	25.0 percentage of participants	30.3 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 48	33.3 percentage of participants	40.4 percentage of participants	21.2 percentage of participants	39.4 percentage of participants	34.3 percentage of participants	36.4 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 Week 52	38.6 percentage of participants	42.9 percentage of participants	27.3 percentage of participants	36.4 percentage of participants	26.5 percentage of participants	39.4 percentage of participants
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 52 EOT	34.9 percentage of participants	38.6 percentage of participants	24.3 percentage of participants	31.6 percentage of participants	25.6 percentage of participants	41.2 percentage of participants

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 at Week 12	12.4 percentage of participants	47.1 percentage of participants	57.9 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 36	69.3 percentage of participants	73.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 44	70.5 percentage of participants	82.4 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 40	76.3 percentage of participants	80.4 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 4	22.4 percentage of participants	24.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 8	36.3 percentage of participants	44.0 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 12	47.0 percentage of participants	59.6 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 24	67.1 percentage of participants	71.9 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 28	67.7 percentage of participants	76.7 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 32	65.6 percentage of participants	70.3 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 48	73.6 percentage of participants	78.8 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 52	71.7 percentage of participants	77.6 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 EOT	66.9 percentage of participants	71.3 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 16	55.4 percentage of participants	63.6 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 52 Week 20	62.2 percentage of participants	69.9 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 at Week 12	4.7 percentage of participants	25.0 percentage of participants	36.3 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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. DAS28 score of less than or equal to 3.2 was considered to be low disease activity.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 4	10.6 percentage of participants	12.9 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 8	17.9 percentage of participants	29.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 12	25.6 percentage of participants	37.3 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 16	34.9 percentage of participants	44.2 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 20	44.5 percentage of participants	48.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 24	52.2 percentage of participants	57.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 28	49.4 percentage of participants	56.0 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 32	52.2 percentage of participants	56.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 36	53.6 percentage of participants	56.8 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 40	58.3 percentage of participants	60.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 44	53.7 percentage of participants	60.8 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 48	55.8 percentage of participants	62.9 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 Week 52	55.2 percentage of participants	60.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 52 EOT	50.6 percentage of participants	57.3 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

Higher CRP indicates greater disease activity.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in CRP at Week 12	-0.001 mg/dL Standard Deviation 2.038	-1.499 mg/dL Standard Deviation 1.855	-1.421 mg/dL Standard Deviation 2.182	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

Higher CRP indicates greater disease activity.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in CRP Through Week 52 Week 4	-1.055 mg/dL Standard Deviation 1.539	-1.411 mg/dL Standard Deviation 1.652	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 8	-1.207 mg/dL Standard Deviation 1.839	-1.569 mg/dL Standard Deviation 1.769	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 44	-1.815 mg/dL Standard Deviation 1.948	-1.725 mg/dL Standard Deviation 2.324	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 48	-1.771 mg/dL Standard Deviation 2.189	-1.751 mg/dL Standard Deviation 2.338	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 52	-1.841 mg/dL Standard Deviation 2.102	-1.912 mg/dL Standard Deviation 1.992	—	—	—	—
Change From Baseline in CRP Through Week 52 EOT	-1.545 mg/dL Standard Deviation 2.315	-1.629 mg/dL Standard Deviation 2.386	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 12	-1.532 mg/dL Standard Deviation 1.849	-1.458 mg/dL Standard Deviation 2.170	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 16	-1.666 mg/dL Standard Deviation 1.828	-1.513 mg/dL Standard Deviation 2.083	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 20	-1.660 mg/dL Standard Deviation 2.050	-1.660 mg/dL Standard Deviation 2.179	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 24	-1.774 mg/dL Standard Deviation 2.022	-1.721 mg/dL Standard Deviation 2.055	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 28	-1.803 mg/dL Standard Deviation 2.150	-1.721 mg/dL Standard Deviation 2.151	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 32	-1.844 mg/dL Standard Deviation 2.214	-1.640 mg/dL Standard Deviation 2.411	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 36	-1.832 mg/dL Standard Deviation 2.005	-1.696 mg/dL Standard Deviation 2.500	—	—	—	—
Change From Baseline in CRP Through Week 52 Week 40	-1.833 mg/dL Standard Deviation 2.156	-1.716 mg/dL Standard Deviation 2.329	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

Higher ESR indicates greater disease activity.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in ESR at Week 12	-2.42 mm/h Standard Deviation 19.71	-18.90 mm/h Standard Deviation 19.85	-22.17 mm/h Standard Deviation 22.79	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

Higher ESR indicates greater disease activity.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=170 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in ESR Through Week 52 Week 4	-11.09 mm/h Standard Deviation 14.34	-16.59 mm/h Standard Deviation 16.68	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 8	-14.96 mm/h Standard Deviation 18.73	-21.10 mm/h Standard Deviation 20.37	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 12	-19.14 mm/h Standard Deviation 19.81	-22.92 mm/h Standard Deviation 22.66	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 16	-21.42 mm/h Standard Deviation 19.70	-24.29 mm/h Standard Deviation 23.14	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 20	-23.22 mm/h Standard Deviation 20.78	-26.20 mm/h Standard Deviation 24.12	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 52	-26.86 mm/h Standard Deviation 23.60	-29.12 mm/h Standard Deviation 23.28	—	—	—	—
Change From Baseline in ESR Through Week 52 EOT	-24.00 mm/h Standard Deviation 24.49	-26.11 mm/h Standard Deviation 25.22	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 24	-25.35 mm/h Standard Deviation 22.48	-27.36 mm/h Standard Deviation 23.23	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 28	-26.03 mm/h Standard Deviation 23.70	-27.88 mm/h Standard Deviation 24.27	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 32	-26.92 mm/h Standard Deviation 23.85	-27.21 mm/h Standard Deviation 24.92	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 36	-25.95 mm/h Standard Deviation 22.68	-27.25 mm/h Standard Deviation 25.10	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 40	-25.86 mm/h Standard Deviation 24.41	-27.74 mm/h Standard Deviation 24.86	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 44	-27.13 mm/h Standard Deviation 22.73	-27.99 mm/h Standard Deviation 23.93	—	—	—	—
Change From Baseline in ESR Through Week 52 Week 48	-25.63 mm/h Standard Deviation 24.72	-27.83 mm/h Standard Deviation 23.29	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12	10.1 percentage of participants	43.0 percentage of participants	55.6 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 20	59.1 percentage of participants	68.1 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 24	65.2 percentage of participants	70.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 28	63.3 percentage of participants	74.2 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 32	63.1 percentage of participants	69.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 36	67.3 percentage of participants	72.9 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 44	65.8 percentage of participants	81.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 52	69.0 percentage of participants	76.9 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 EOT	64.5 percentage of participants	70.8 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 4	19.4 percentage of participants	21.8 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 8	30.4 percentage of participants	41.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 12	42.9 percentage of participants	57.2 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 16	51.8 percentage of participants	60.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 40	73.7 percentage of participants	79.1 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 Week 48	71.6 percentage of participants	78.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12	35.5 percentage of participants	77.9 percentage of participants	84.8 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 4	67.1 percentage of participants	77.1 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 12	78.6 percentage of participants	85.5 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 16	84.3 percentage of participants	89.1 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 24	89.4 percentage of participants	95.6 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 28	91.1 percentage of participants	93.7 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 32	93.0 percentage of participants	94.2 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 36	94.8 percentage of participants	95.5 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 40	92.8 percentage of participants	96.1 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 44	95.3 percentage of participants	94.1 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 52	95.2 percentage of participants	94.6 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 EOT	88.4 percentage of participants	92.4 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 8	73.8 percentage of participants	80.1 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 20	86.6 percentage of participants	91.4 percentage of participants	—	—	—	—
Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 Week 48	95.3 percentage of participants	97.4 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a EULAR Good Response Using DAS28-ESR at Week 12	4.1 percentage of participants	23.8 percentage of participants	34.5 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 12	24.4 percentage of participants	35.5 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 16	34.3 percentage of participants	43.6 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 20	43.3 percentage of participants	46.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 24	51.6 percentage of participants	55.6 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 28	48.1 percentage of participants	54.1 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 32	51.0 percentage of participants	54.8 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 36	53.6 percentage of participants	54.8 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 40	57.6 percentage of participants	58.6 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 44	52.4 percentage of participants	59.5 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 4	7.6 percentage of participants	12.4 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 8	16.1 percentage of participants	28.3 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 48	53.7 percentage of participants	60.9 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 Week 52	53.8 percentage of participants	59.2 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 52 EOT	49.4 percentage of participants	56.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR at Week 12	32.0 percentage of participants	74.4 percentage of participants	78.9 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 28	88.0 percentage of participants	91.2 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 36	94.1 percentage of participants	94.8 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 44	96.6 percentage of participants	94.1 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 EOT	86.0 percentage of participants	90.6 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 4	55.9 percentage of participants	68.2 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 8	72.0 percentage of participants	76.5 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 12	75.0 percentage of participants	80.1 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 16	80.7 percentage of participants	87.9 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 20	82.3 percentage of participants	92.0 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 24	87.6 percentage of participants	91.9 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 32	90.4 percentage of participants	92.9 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 40	92.7 percentage of participants	94.1 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 48	94.6 percentage of participants	95.4 percentage of participants	—	—	—	—
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 52 Week 52	93.8 percentage of participants	94.6 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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).

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving ACR / EULAR Remission at Week 12	0.6 percentage of participants	5.8 percentage of participants	9.9 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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).

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 28	14.6 percentage of participants	20.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 32	17.2 percentage of participants	25.8 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 4	1.2 percentage of participants	1.2 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 8	1.2 percentage of participants	3.6 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 12	6.0 percentage of participants	10.2 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 16	9.0 percentage of participants	12.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 20	11.0 percentage of participants	14.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 24	11.8 percentage of participants	18.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 36	17.0 percentage of participants	27.7 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 40	19.1 percentage of participants	20.9 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 44	16.1 percentage of participants	20.3 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 48	17.6 percentage of participants	21.2 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 Week 52	21.4 percentage of participants	26.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 EOT	19.2 percentage of participants	23.4 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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. SDAI Remission was defined as SDAI score ≤ 3.3.

Outcome measures

Measure	Placebo n=169 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission <=3.3 at Week 12	0.6 percentage of participants	7.0 percentage of participants	14.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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. SDAI Remission was defined as SDAI score ≤ 3.3.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 12	7.1 percentage of participants	14.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 16	14.5 percentage of participants	18.2 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 20	18.3 percentage of participants	20.9 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 24	20.5 percentage of participants	22.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 28	22.2 percentage of participants	23.3 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 40	31.6 percentage of participants	28.8 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 48	25.7 percentage of participants	32.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 52	30.3 percentage of participants	39.5 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 EOT	28.5 percentage of participants	35.1 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 4	1.2 percentage of participants	2.4 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 8	3.0 percentage of participants	8.4 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 32	25.5 percentage of participants	28.4 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 36	24.2 percentage of participants	32.9 percentage of participants	—	—	—	—
Percentage of Participants Achieving SDAI Remission Score <=3.3 Through Week 52 Week 44	27.5 percentage of participants	30.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SDAI Score at Week 12	-4.90 units on a scale Standard Deviation 12.32	-15.66 units on a scale Standard Deviation 12.69	-19.57 units on a scale Standard Deviation 13.53	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SDAI Score Through Week 52 Week 4	-11.02 units on a scale Standard Deviation 8.23	-13.79 units on a scale Standard Deviation 10.43	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 8	-14.60 units on a scale Standard Deviation 10.40	-18.36 units on a scale Standard Deviation 11.76	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 12	-15.94 units on a scale Standard Deviation 12.59	-20.08 units on a scale Standard Deviation 13.08	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 16	-18.75 units on a scale Standard Deviation 11.58	-22.21 units on a scale Standard Deviation 12.56	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 20	-20.24 units on a scale Standard Deviation 11.89	-23.03 units on a scale Standard Deviation 13.26	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 24	-21.62 units on a scale Standard Deviation 11.64	-24.68 units on a scale Standard Deviation 11.52	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 36	-22.89 units on a scale Standard Deviation 11.10	-25.55 units on a scale Standard Deviation 11.74	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 40	-23.55 units on a scale Standard Deviation 11.20	-26.14 units on a scale Standard Deviation 11.93	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 28	-21.89 units on a scale Standard Deviation 11.54	-24.57 units on a scale Standard Deviation 12.17	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 32	-22.61 units on a scale Standard Deviation 11.15	-25.38 units on a scale Standard Deviation 11.91	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 44	-23.55 units on a scale Standard Deviation 11.17	-26.44 units on a scale Standard Deviation 12.15	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 48	-23.23 units on a scale Standard Deviation 11.30	-26.50 units on a scale Standard Deviation 12.12	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 Week 52	-23.67 units on a scale Standard Deviation 11.91	-26.63 units on a scale Standard Deviation 12.82	—	—	—	—
Change From Baseline in SDAI Score Through Week 52 EOT	-21.48 units on a scale Standard Deviation 13.42	-24.72 units on a scale Standard Deviation 14.13	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in PGA at Week 12	-11.88 units on a scale Standard Deviation 21.46	-28.83 units on a scale Standard Deviation 22.21	-35.96 units on a scale Standard Deviation 25.00	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

The investigator assessed the participants disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in PGA Through Week 52 Week 4	-18.36 units on a scale Standard Deviation 17.10	-22.94 units on a scale Standard Deviation 19.32	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 8	-25.79 units on a scale Standard Deviation 19.59	-31.54 units on a scale Standard Deviation 22.43	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 12	-29.07 units on a scale Standard Deviation 22.22	-36.55 units on a scale Standard Deviation 24.64	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 16	-33.60 units on a scale Standard Deviation 21.27	-38.86 units on a scale Standard Deviation 23.83	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 20	-36.18 units on a scale Standard Deviation 21.87	-41.44 units on a scale Standard Deviation 22.71	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 24	-37.13 units on a scale Standard Deviation 21.71	-43.67 units on a scale Standard Deviation 21.39	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 28	-38.72 units on a scale Standard Deviation 22.45	-42.43 units on a scale Standard Deviation 21.27	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 32	-40.04 units on a scale Standard Deviation 20.82	-43.96 units on a scale Standard Deviation 21.78	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 36	-39.35 units on a scale Standard Deviation 21.25	-44.37 units on a scale Standard Deviation 21.77	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 40	-41.04 units on a scale Standard Deviation 22.33	-44.32 units on a scale Standard Deviation 21.54	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 44	-41.47 units on a scale Standard Deviation 22.73	-46.00 units on a scale Standard Deviation 21.60	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 48	-41.55 units on a scale Standard Deviation 23.23	-45.84 units on a scale Standard Deviation 21.83	—	—	—	—
Change From Baseline in PGA Through Week 52 Week 52	-41.49 units on a scale Standard Deviation 23.75	-45.46 units on a scale Standard Deviation 23.75	—	—	—	—
Change From Baseline in PGA Through Week 52 EOT	-38.41 units on a scale Standard Deviation 25.07	-43.33 units on a scale Standard Deviation 24.31	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SGA at Week 12	-7.11 units on a scale Standard Deviation 23.05	-21.09 units on a scale Standard Deviation 23.63	-26.57 units on a scale Standard Deviation 25.43	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SGA Through Week 52 Week 32	-31.92 units on a scale Standard Deviation 24.99	-33.46 units on a scale Standard Deviation 24.28	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 36	-32.38 units on a scale Standard Deviation 25.34	-34.01 units on a scale Standard Deviation 23.83	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 40	-32.80 units on a scale Standard Deviation 25.85	-34.24 units on a scale Standard Deviation 23.85	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 44	-33.49 units on a scale Standard Deviation 25.86	-35.31 units on a scale Standard Deviation 25.23	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 48	-33.69 units on a scale Standard Deviation 26.18	-35.33 units on a scale Standard Deviation 23.77	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 4	-13.80 units on a scale Standard Deviation 19.47	-17.59 units on a scale Standard Deviation 20.25	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 8	-19.11 units on a scale Standard Deviation 23.22	-24.97 units on a scale Standard Deviation 22.65	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 12	-21.59 units on a scale Standard Deviation 23.43	-27.40 units on a scale Standard Deviation 24.84	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 16	-25.20 units on a scale Standard Deviation 24.41	-30.14 units on a scale Standard Deviation 24.29	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 20	-26.94 units on a scale Standard Deviation 25.49	-31.20 units on a scale Standard Deviation 25.39	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 24	-29.00 units on a scale Standard Deviation 25.51	-32.79 units on a scale Standard Deviation 25.68	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 28	-30.04 units on a scale Standard Deviation 24.96	-34.25 units on a scale Standard Deviation 25.01	—	—	—	—
Change From Baseline in SGA Through Week 52 Week 52	-33.18 units on a scale Standard Deviation 27.83	-36.16 units on a scale Standard Deviation 25.27	—	—	—	—
Change From Baseline in SGA Through Week 52 EOT	-29.34 units on a scale Standard Deviation 28.78	-34.05 units on a scale Standard Deviation 26.60	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SGAP at Week 12	-6.64 units on a scale Standard Deviation 25.22	-21.09 units on a scale Standard Deviation 27.04	-26.87 units on a scale Standard Deviation 26.65	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only Peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SGAP Through Week 52 Week 4	-12.94 units on a scale Standard Deviation 20.75	-16.18 units on a scale Standard Deviation 22.06	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 8	-19.10 units on a scale Standard Deviation 25.81	-24.98 units on a scale Standard Deviation 23.68	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 12	-21.27 units on a scale Standard Deviation 27.03	-27.81 units on a scale Standard Deviation 26.13	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 16	-24.03 units on a scale Standard Deviation 26.09	-28.42 units on a scale Standard Deviation 26.88	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 20	-25.57 units on a scale Standard Deviation 28.52	-30.63 units on a scale Standard Deviation 26.68	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 24	-27.34 units on a scale Standard Deviation 27.54	-32.72 units on a scale Standard Deviation 26.04	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 28	-28.54 units on a scale Standard Deviation 27.24	-34.18 units on a scale Standard Deviation 25.89	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 32	-31.32 units on a scale Standard Deviation 25.76	-33.74 units on a scale Standard Deviation 25.44	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 36	-31.95 units on a scale Standard Deviation 26.17	-32.66 units on a scale Standard Deviation 26.25	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 40	-32.17 units on a scale Standard Deviation 26.81	-34.07 units on a scale Standard Deviation 25.22	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 44	-32.73 units on a scale Standard Deviation 26.67	-34.88 units on a scale Standard Deviation 25.27	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 48	-33.60 units on a scale Standard Deviation 25.87	-35.07 units on a scale Standard Deviation 25.05	—	—	—	—
Change From Baseline in SGAP Through Week 52 Week 52	-33.34 units on a scale Standard Deviation 26.98	-35.00 units on a scale Standard Deviation 27.37	—	—	—	—
Change From Baseline in SGAP Through Week 52 EOT	-28.94 units on a scale Standard Deviation 28.63	-32.68 units on a scale Standard Deviation 28.48	—	—	—	—

SECONDARY outcome

Timeframe: Up to week 52

Population: FAS.

Participants who discontinued due to lack of efficacy have been reported.

Outcome measures

Measure	Placebo n=175 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=85 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=85 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Number of Participants Who Withdrew Due to Lack of Efficacy	10 Participants	6 Participants	3 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in HAQ-DI at Week 12	0.01 units on a scale Standard Deviation 0.47	-0.22 units on a scale Standard Deviation 0.44	-0.37 units on a scale Standard Deviation 0.48	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in HAQ-DI Through Week 52 Week 20	-0.33 units on a scale Standard Deviation 0.48	-0.47 units on a scale Standard Deviation 0.53	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 24	-0.36 units on a scale Standard Deviation 0.50	-0.48 units on a scale Standard Deviation 0.52	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 4	-0.08 units on a scale Standard Deviation 0.30	-0.21 units on a scale Standard Deviation 0.36	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 12	-0.23 units on a scale Standard Deviation 0.44	-0.38 units on a scale Standard Deviation 0.47	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 16	-0.30 units on a scale Standard Deviation 0.46	-0.41 units on a scale Standard Deviation 0.51	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 28	-0.36 units on a scale Standard Deviation 0.51	-0.51 units on a scale Standard Deviation 0.52	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 32	-0.37 units on a scale Standard Deviation 0.51	-0.53 units on a scale Standard Deviation 0.54	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 40	-0.42 units on a scale Standard Deviation 0.50	-0.56 units on a scale Standard Deviation 0.52	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 44	-0.45 units on a scale Standard Deviation 0.50	-0.54 units on a scale Standard Deviation 0.53	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 52	-0.43 units on a scale Standard Deviation 0.51	-0.56 units on a scale Standard Deviation 0.54	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 8	-0.18 units on a scale Standard Deviation 0.41	-0.32 units on a scale Standard Deviation 0.42	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 36	-0.39 units on a scale Standard Deviation 0.50	-0.53 units on a scale Standard Deviation 0.52	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 Week 48	-0.44 units on a scale Standard Deviation 0.49	-0.56 units on a scale Standard Deviation 0.53	—	—	—	—
Change From Baseline in HAQ-DI Through Week 52 EOT	-0.36 units on a scale Standard Deviation 0.55	-0.51 units on a scale Standard Deviation 0.56	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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 Roll/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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12	0.57 units on a scale Standard Deviation 12.08	6.60 units on a scale Standard Deviation 11.06	9.02 units on a scale Standard Deviation 11.54	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned

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 Roll/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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 Week 4	3.84 units on a scale Standard Deviation 8.91	5.77 units on a scale Standard Deviation 11.05	—	—	—	—
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 Week 12	6.68 units on a scale Standard Deviation 11.08	9.32 units on a scale Standard Deviation 11.55	—	—	—	—
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 Week 52	11.27 units on a scale Standard Deviation 12.05	12.45 units on a scale Standard Deviation 12.45	—	—	—	—
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 EOT	9.92 units on a scale Standard Deviation 12.81	11.51 units on a scale Standard Deviation 12.77	—	—	—	—
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 Week 8	4.92 units on a scale Standard Deviation 10.82	7.91 units on a scale Standard Deviation 11.88	—	—	—	—
Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 Week 28	9.89 units on a scale Standard Deviation 11.86	12.44 units on a scale Standard Deviation 11.88	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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 Roll/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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12	1.07 units on a scale Standard Deviation 8.27	3.28 units on a scale Standard Deviation 7.47	2.50 units on a scale Standard Deviation 8.44	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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 Roll/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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 Week 4	1.45 units on a scale Standard Deviation 7.02	1.33 units on a scale Standard Deviation 7.93	—	—	—	—
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 Week 8	2.72 units on a scale Standard Deviation 7.39	2.44 units on a scale Standard Deviation 8.47	—	—	—	—
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 Week 12	3.44 units on a scale Standard Deviation 7.47	2.67 units on a scale Standard Deviation 8.23	—	—	—	—
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 Week 28	3.06 units on a scale Standard Deviation 8.55	3.12 units on a scale Standard Deviation 8.20	—	—	—	—
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 Week 52	2.62 units on a scale Standard Deviation 9.10	1.85 units on a scale Standard Deviation 8.71	—	—	—	—
Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 EOT	2.21 units on a scale Standard Deviation 8.89	1.67 units on a scale Standard Deviation 8.90	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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 Roll/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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=172 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=171 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12	-0.09 units on a scale Standard Deviation 16.69	2.30 units on a scale Standard Deviation 13.92	3.90 units on a scale Standard Deviation 13.35	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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 Roll/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.

Outcome measures

Measure	Placebo n=172 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 Week 8	2.50 units on a scale Standard Deviation 13.79	3.30 units on a scale Standard Deviation 13.43	—	—	—	—
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 Week 12	2.32 units on a scale Standard Deviation 14.05	3.92 units on a scale Standard Deviation 13.31	—	—	—	—
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 Week 4	1.41 units on a scale Standard Deviation 11.51	1.70 units on a scale Standard Deviation 11.44	—	—	—	—
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 Week 28	4.06 units on a scale Standard Deviation 14.92	4.81 units on a scale Standard Deviation 13.83	—	—	—	—
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 Week 52	4.30 units on a scale Standard Deviation 15.31	7.17 units on a scale Standard Deviation 14.05	—	—	—	—
Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 EOT	3.49 units on a scale Standard Deviation 14.85	5.88 units on a scale Standard Deviation 14.31	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=98 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=82 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=95 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12	-0.82 percent work time missed Standard Deviation 17.77	0.36 percent work time missed Standard Deviation 18.15	-1.46 percent work time missed Standard Deviation 15.26	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=82 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=95 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in WPAI Percent Work Time Missed Through Week 52 Week 4	-0.90 percent work time missed Standard Deviation 16.50	0.02 percent work time missed Standard Deviation 16.53	—	—	—	—
Change From Baseline in WPAI Percent Work Time Missed Through Week 52 Week 12	-0.70 percent work time missed Standard Deviation 14.69	-1.97 percent work time missed Standard Deviation 12.14	—	—	—	—
Change From Baseline in WPAI Percent Work Time Missed Through Week 52 Week 8	-1.48 percent work time missed Standard Deviation 15.72	-1.73 percent work time missed Standard Deviation 16.59	—	—	—	—
Change From Baseline in WPAI Percent Work Time Missed Through Week 52 Week 28	-0.58 percent work time missed Standard Deviation 19.15	-3.49 percent work time missed Standard Deviation 13.77	—	—	—	—
Change From Baseline in WPAI Percent Work Time Missed Through Week 52 Week 52	-1.93 percent work time missed Standard Deviation 12.14	-1.66 percent work time missed Standard Deviation 18.74	—	—	—	—
Change From Baseline in WPAI Percent Work Time Missed Through Week 52 EOT	-1.76 percent work time missed Standard Deviation 14.68	-1.66 percent work time missed Standard Deviation 20.31	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=95 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=82 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=94 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in WPAI Percent Impairment While Working at Week 12	-2.42 percent work impairment Standard Deviation 27.78	-11.71 percent work impairment Standard Deviation 25.62	-15.96 percent work impairment Standard Deviation 28.30	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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 calculates as Q5/10. Negative values indicate improvement from baseline.

Outcome measures

Measure	Placebo n=83 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=94 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in WPAI Percent Impairment While Working Through Week 52 Week 4	-10.00 percent work impairment Standard Deviation 22.39	-6.56 percent work impairment Standard Deviation 29.31	—	—	—	—
Change From Baseline in WPAI Percent Impairment While Working Through Week 52 Week 8	-12.50 percent work impairment Standard Deviation 24.93	-13.98 percent work impairment Standard Deviation 26.37	—	—	—	—
Change From Baseline in WPAI Percent Impairment While Working Through Week 52 Week 12	-11.97 percent work impairment Standard Deviation 26.33	-16.29 percent work impairment Standard Deviation 27.77	—	—	—	—
Change From Baseline in WPAI Percent Impairment While Working Through Week 52 Week 28	-20.00 percent work impairment Standard Deviation 25.27	-21.40 percent work impairment Standard Deviation 25.21	—	—	—	—
Change From Baseline in WPAI Percent Impairment While Working Through Week 52 Week 52	-22.97 percent work impairment Standard Deviation 29.90	-22.41 percent work impairment Standard Deviation 28.16	—	—	—	—
Change From Baseline in WPAI Percent Impairment While Working Through Week 52 EOT	-17.35 percent work impairment Standard Deviation 29.10	-20.43 percent work impairment Standard Deviation 28.85	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=95 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=81 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=94 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in Percent Overall Work Impairment at Week 12	-2.75 percent overall work impairment Standard Deviation 28.56	-11.58 percent overall work impairment Standard Deviation 26.22	-16.91 percent overall work impairment Standard Deviation 29.23	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=82 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=94 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 Week 4	-10.61 percent overall work impairment Standard Deviation 22.36	-7.51 percent overall work impairment Standard Deviation 30.12	—	—	—	—
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 Week 8	-13.13 percent overall work impairment Standard Deviation 25.07	-14.67 percent overall work impairment Standard Deviation 26.94	—	—	—	—
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 Week 12	-12.15 percent overall work impairment Standard Deviation 26.81	-17.15 percent overall work impairment Standard Deviation 28.94	—	—	—	—
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 Week 28	-20.76 percent overall work impairment Standard Deviation 25.78	-22.49 percent overall work impairment Standard Deviation 26.69	—	—	—	—
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 Week 52	-22.48 percent overall work impairment Standard Deviation 30.96	-23.40 percent overall work impairment Standard Deviation 29.54	—	—	—	—
Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 EOT	-17.43 percent overall work impairment Standard Deviation 30.01	-21.59 percent overall work impairment Standard Deviation 29.88	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and week 12/ET

Population: FAS. Here, Number of participants analyzed signifies participants with available data. LOCF was used for missing imputations.

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.

Outcome measures

Measure	Placebo n=168 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=171 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=170 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in WPAI Percent Activity Impairment at Week 12	-2.50 percent activity impairment Standard Deviation 28.19	-13.98 percent activity impairment Standard Deviation 27.17	-19.35 percent activity impairment Standard Deviation 24.28	—	—	—

SECONDARY outcome

Timeframe: Baseline, weeks 4, 8, 12, 28, 52 and EOT

Population: FAS. Here, Number of participants analyzed signifies participants with available data. Only peficitinib 100 mg and 150 mg arms are analyzed for this outcome measure, as planned.

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.

Outcome measures

Measure	Placebo n=171 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=170 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Change From Baseline in WPAI Percent Activity Impairment Through Week 52 Week 4	-9.23 percent activity impairment Standard Deviation 22.81	-10.65 percent activity impairment Standard Deviation 22.18	—	—	—	—
Change From Baseline in WPAI Percent Activity Impairment Through Week 52 Week 8	-13.07 percent activity impairment Standard Deviation 26.12	-17.44 percent activity impairment Standard Deviation 24.28	—	—	—	—
Change From Baseline in WPAI Percent Activity Impairment Through Week 52 Week 12	-13.71 percent activity impairment Standard Deviation 27.30	-19.88 percent activity impairment Standard Deviation 24.32	—	—	—	—
Change From Baseline in WPAI Percent Activity Impairment Through Week 52 Week 28	-22.17 percent activity impairment Standard Deviation 27.25	-26.99 percent activity impairment Standard Deviation 24.72	—	—	—	—
Change From Baseline in WPAI Percent Activity Impairment Through Week 52 Week 52	-24.10 percent activity impairment Standard Deviation 31.72	-26.71 percent activity impairment Standard Deviation 24.78	—	—	—	—
Change From Baseline in WPAI Percent Activity Impairment Through Week 52 EOT	-21.58 percent activity impairment Standard Deviation 31.67	-23.47 percent activity impairment Standard Deviation 25.96	—	—	—	—

SECONDARY outcome

Timeframe: Week 0 to week 12

Population: SAF.

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.

Outcome measures

Measure	Placebo n=170 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=174 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=174 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks Serious TEAEs	4 Participants	5 Participants	3 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks Drug-related serious TEAEs	2 Participants	3 Participants	3 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks ≥ Grade 3 TEAEs	8 Participants	9 Participants	16 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks Drug-Related AE leading to permanent discont.	6 Participants	3 Participants	5 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks Drug-related TEAEs	47 Participants	57 Participants	80 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks TEAEs leading to death	0 Participants	0 Participants	0 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks TEAEs leading to permanent discontinuation	7 Participants	5 Participants	5 Participants	—	—	—
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) During the First 12 Weeks TEAEs	84 Participants	89 Participants	104 Participants	—	—	—

SECONDARY outcome

Timeframe: Week 12 to week 28

Population: SAF. Here, Number of participants analyzed signifies participants with available data.

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on NCI-CTCAE, AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE

Outcome measures

Measure	Placebo n=82 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=167 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=165 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=37 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=38 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Number of Participants With TEAEs From Week 12 to Week 28 Drug-related TEAEs	27 Participants	63 Participants	72 Participants	16 Participants	11 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 TEAEs leading to death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 Drug-related serious TEAEs	2 Participants	3 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 TEAEs	50 Participants	95 Participants	104 Participants	21 Participants	25 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 Serious TEAEs	2 Participants	5 Participants	3 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 ≥ Grade 3 TEAEs	5 Participants	7 Participants	6 Participants	1 Participants	1 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 TEAEs leading to permanent discontinuation	4 Participants	4 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs From Week 12 to Week 28 Drug-Related TEAE leading to permanent dicont.	3 Participants	3 Participants	1 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Week 28 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study

Population: SAF. Here, Number of participants analyzed signifies participants with available data.

TEAEs were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), AEs were graded as grade 1=mild; grade 2=moderate: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE.

Outcome measures

Measure	Placebo n=158 Participants Participants who received placebo matching to peficitinib 100 mg or 150 mg orally once daily in combination with MTX until week 12 or 28 were switched to receive 100 mg or 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 or 28 to week 52.	Peficitinib 100 mg n=158 Participants Participants received 100 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Peficitinib 150 mg n=36 Participants Participants received 150 mg tablet of peficitinib orally once daily in combination with MTX for a period of 52 weeks.	Placebo / Peficitinib 150 mg at Week 12 n=36 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 12 to week 52.	Placebo / Peficitinib 100 mg at Week 28 n=39 Participants Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.	Placebo / Peficitinib 150 mg at Week 28 n=34 Participants Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 150 mg tablet of peficitinib orally once daily in combination with MTX from week 28 to week 52.
Number of Participants With TEAEs From Week 28 to Week 52 Serious TEAEs	10 Participants	8 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With TEAEs From Week 28 to Week 52 Drug-related serious TEAEs	4 Participants	5 Participants	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With TEAEs From Week 28 to Week 52 TEAEs leading to permanent discontinuation	4 Participants	6 Participants	3 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With TEAEs From Week 28 to Week 52 TEAEs	114 Participants	112 Participants	22 Participants	27 Participants	25 Participants	26 Participants
Number of Participants With TEAEs From Week 28 to Week 52 Drug-related TEAEs	72 Participants	74 Participants	14 Participants	18 Participants	17 Participants	17 Participants
Number of Participants With TEAEs From Week 28 to Week 52 TEAEs leading to death	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With TEAEs From Week 28 to Week 52 ≥ Grade 3 TEAEs	15 Participants	15 Participants	2 Participants	2 Participants	2 Participants	2 Participants

Adverse Events

Week 0 to Week 12: Placebo

Serious events: 4 serious events

Other events: 42 other events

Deaths: 0 deaths

Week 0 to Week 12: Peficitinib 100 mg

Serious events: 5 serious events

Other events: 54 other events

Deaths: 0 deaths

Week 0 to Week 12: Peficitinib 150 mg

Serious events: 3 serious events

Other events: 61 other events

Deaths: 0 deaths

Week 12 to Week 28: Placebo

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Week 12 to Week 28: Peficitinib 100 mg

Serious events: 5 serious events

Other events: 56 other events

Deaths: 0 deaths

Week 12 to Week 28: Peficitinib 150 mg

Serious events: 3 serious events

Other events: 60 other events

Deaths: 0 deaths

Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Week 28 to Week 52: Peficitinib 100 mg

Serious events: 10 serious events

Other events: 63 other events

Deaths: 0 deaths

Week 28 to Week 52: Peficitinib 150 mg

Serious events: 8 serious events

Other events: 73 other events

Deaths: 0 deaths

Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28

Serious events: 1 serious events

Other events: 15 other events

Deaths: 1 deaths

Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Measure	Week 0 to Week 12: Placebo n=170 participants at risk Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12.	Week 0 to Week 12: Peficitinib 100 mg n=174 participants at risk Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.	Week 0 to Week 12: Peficitinib 150 mg n=174 participants at risk Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.	Week 12 to Week 28: Placebo n=82 participants at risk Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.	Week 12 to Week 28: Peficitinib 100 mg n=167 participants at risk Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.	Week 12 to Week 28: Peficitinib 150 mg n=165 participants at risk Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.	Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12 n=37 participants at risk Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 28.	Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12 n=38 participants at risk Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 28.	Week 28 to Week 52: Peficitinib 100 mg n=158 participants at risk Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.	Week 28 to Week 52: Peficitinib 150 mg n=158 participants at risk Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.	Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12 n=36 participants at risk Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 52.	Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12 n=36 participants at risk Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 52.	Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28 n=39 participants at risk Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.	Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28 n=34 participants at risk Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
Renal and urinary disorders Nephrolithiasis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Respiratory, thoracic and mediastinal disorders Alveolitis allergic	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Nervous system disorders Lacunar infarction	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Psychiatric disorders Completed suicide	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Psychiatric disorders Mania	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Cardiac disorders Pericarditis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Ear and labyrinth disorders Vertigo positional	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Eye disorders Retinal detachment	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Gastrointestinal disorders Colonic polyp	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Gastrointestinal disorders Gastric ulcer	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 1/34 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Cellulitis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Gastroenteritis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Gastroenteritis viral	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Herpes zoster	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Pneumonia	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Pneumonia cryptococcal	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Pyelonephritis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Injury, poisoning and procedural complications Brachial plexus injury	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/167 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Investigations Investigation	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Nervous system disorders Cerebellar haemorrhage	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Respiratory, thoracic and mediastinal disorders Status asthmaticus	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/165 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.

Other adverse events

Measure	Week 0 to Week 12: Placebo n=170 participants at risk Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12.	Week 0 to Week 12: Peficitinib 100 mg n=174 participants at risk Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.	Week 0 to Week 12: Peficitinib 150 mg n=174 participants at risk Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX for a period of 12 weeks.	Week 12 to Week 28: Placebo n=82 participants at risk Participants received placebo matched to peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.	Week 12 to Week 28: Peficitinib 100 mg n=167 participants at risk Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.	Week 12 to Week 28: Peficitinib 150 mg n=165 participants at risk Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 12 and from week 12 to 28.	Week 12 to Week 28: Placebo / Peficitinib 100 mg at Week 12 n=37 participants at risk Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 28.	Week 12 to Week 28: Placebo / Peficitinib 150 mg at Week 12 n=38 participants at risk Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 28.	Week 28 to Week 52: Peficitinib 100 mg n=158 participants at risk Participants received 100 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.	Week 28 to Week 52: Peficitinib 150 mg n=158 participants at risk Participants received 150 mg tablet of Peficitinib orally once daily in combination with MTX until week 28 and from week 28 to 52.	Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 12 n=36 participants at risk Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 12 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 12 to week 52.	Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 12 n=36 participants at risk Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 12 were switched to receive 150 mg tablet orally once daily in combination with MTX from week 12 to week 52.	Week 28 to Week 52: Placebo / Peficitinib 100 mg at Week 28 n=39 participants at risk Participants who received placebo matched to peficitinib 100 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.	Week 28 to Week 52: Placebo / Peficitinib 150 mg at Week 28 n=34 participants at risk Participants who received placebo matched to peficitinib 150 mg orally once daily in combination with MTX until week 28 were switched to receive 100 mg tablet orally once daily in combination with MTX from week 28 to week 52.
Gastrointestinal disorders Diarrhoea	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.3% 4/174 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 5/174 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/167 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/165 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.9% 3/158 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.9% 2/34 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Gastrointestinal disorders Dyspepsia	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.3% 2/38 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Gastrointestinal disorders Nausea	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 5/174 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.7% 1/37 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.9% 3/158 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	7.7% 3/39 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Gastrointestinal disorders Stomatitis	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.3% 4/174 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/165 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.3% 2/38 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.5% 4/158 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Gastrointestinal disorders Vomiting	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.4% 2/37 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.9% 2/34 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Hepatobiliary disorders Hepatic function abnormal	2.4% 4/170 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 5/174 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.4% 6/174 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.4% 4/167 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.0% 5/165 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.2% 5/158 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	11.8% 4/34 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Bronchitis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.4% 2/82 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/167 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.4% 4/165 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.7% 1/37 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.2% 5/158 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	11.1% 4/36 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	8.8% 3/34 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Cystitis	1.2% 2/170 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/167 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/165 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.4% 2/37 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.9% 3/158 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.5% 4/158 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Gastroenteritis	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/167 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/165 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.7% 1/37 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.5% 4/158 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.9% 3/158 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	8.3% 3/36 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Influenza	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.9% 3/158 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.1% 2/39 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Nasopharyngitis	8.2% 14/170 • Number of events 17 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	10.9% 19/174 • Number of events 19 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	9.2% 16/174 • Number of events 16 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	14.6% 12/82 • Number of events 14 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	12.0% 20/167 • Number of events 24 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	11.5% 19/165 • Number of events 22 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	16.2% 6/37 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.3% 2/38 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	15.8% 25/158 • Number of events 27 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	24.1% 38/158 • Number of events 40 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	16.7% 6/36 • Number of events 7 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	16.7% 6/36 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	10.3% 4/39 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	17.6% 6/34 • Number of events 8 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Pharyngitis	3.5% 6/170 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.4% 6/174 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.0% 5/167 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/165 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.3% 2/38 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.5% 4/158 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.8% 6/158 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Infections and infestations Upper respiratory tract infection	2.4% 4/170 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/167 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.6% 6/165 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.5% 4/158 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.2% 5/158 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	11.1% 4/36 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.1% 2/39 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 1/34 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Investigations Blood creatine phosphokinase increased	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 5/174 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.60% 1/167 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	4.2% 7/165 • Number of events 8 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.7% 1/37 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.8% 6/158 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.7% 9/158 • Number of events 10 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	8.3% 3/36 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.1% 2/39 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	8.8% 3/34 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Metabolism and nutrition disorders Dyslipidaemia	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.3% 4/174 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/167 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.9% 2/34 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/170 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/167 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/165 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.4% 2/37 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.9% 1/34 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Musculoskeletal and connective tissue disorders Back pain	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.57% 1/174 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.7% 3/82 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.0% 5/167 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.5% 4/158 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/39 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	11.8% 4/34 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	3.5% 6/170 • Number of events 7 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.3% 4/174 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.7% 3/82 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/167 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.7% 1/37 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/38 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.9% 3/158 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.8% 1/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.1% 2/174 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/82 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	4.2% 7/167 • Number of events 9 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/165 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.63% 1/158 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	8.3% 3/36 • Number of events 4 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.1% 2/39 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Skin and subcutaneous tissue disorders Rash	0.59% 1/170 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/167 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.61% 1/165 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.7% 1/37 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.3% 2/158 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/158 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	5.6% 2/36 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/34 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.
Vascular disorders Hypertension	1.2% 2/170 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/174 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.7% 3/174 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 1/82 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.2% 2/167 • Number of events 2 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	1.8% 3/165 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/37 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/38 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.2% 5/158 • Number of events 5 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	3.8% 6/158 • Number of events 6 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	0.00% 0/36 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	2.6% 1/39 • Number of events 1 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.	8.8% 3/34 • Number of events 3 • Week 0 to week 12, week 12 to week 28, and week 28 to week 52 plus 28 days after the week 52 visit for participants who did not enroll in the extension study. SAF.

Additional Information

Clinical Trial Disclosure

Astellas Pharma Inc.

Phone: +81-3-3244-6500 Japanese only

Email: Astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
• Publication restrictions are in place

Restriction type: OTHER