Trial Outcomes & Findings for A Study in Moderate to Severe Rheumatoid Arthritis (NCT NCT01710358)

Last Updated: 2019-09-18

Results Overview

ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1307 participants

Primary outcome timeframe

Week 12

Results posted on

2019-09-18

Participant Flow

Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week16. Participants not rescued at Week 16 may be rescued at the discretion of the investigator anytime thereafter. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count.

Participant milestones

Participant milestones
Measure	Placebo Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.	Baricitinib Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Treatment Period Part A (Weeks 0 to 24) STARTED	489	488	330
Treatment Period Part A (Weeks 0 to 24) Received at Least 1 Dose of Study Drug	488	487	330
Treatment Period Part A (Weeks 0 to 24) Rescued	128	35	40
Treatment Period Part A (Weeks 0 to 24) COMPLETED	438	459	307
Treatment Period Part A (Weeks 0 to 24) NOT COMPLETED	51	29	23
Treatment Period Part B (Weeks 24 to 52) STARTED	310	424	267
Treatment Period Part B (Weeks 24 to 52) Received at Least 1 Dose of Study Drug	306	424	267
Treatment Period Part B (Weeks 24 to 52) Rescued	5	8	11
Treatment Period Part B (Weeks 24 to 52) COMPLETED	294	402	252
Treatment Period Part B (Weeks 24 to 52) NOT COMPLETED	16	22	15
Rescue Period STARTED	0	227	0
Rescue Period COMPLETED	0	196	0
Rescue Period NOT COMPLETED	0	31	0
Follow-up Period STARTED	33	76	20
Follow-up Period COMPLETED	33	76	20
Follow-up Period NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.	Baricitinib Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Treatment Period Part A (Weeks 0 to 24) Adverse Event	15	18	7
Treatment Period Part A (Weeks 0 to 24) Death	0	2	0
Treatment Period Part A (Weeks 0 to 24) Entry Criteria Not Met	0	1	1
Treatment Period Part A (Weeks 0 to 24) Lack of Efficacy	15	1	3
Treatment Period Part A (Weeks 0 to 24) Lost to Follow-up	0	1	0
Treatment Period Part A (Weeks 0 to 24) Physician Decision	1	0	0
Treatment Period Part A (Weeks 0 to 24) Sponsor Decision	4	0	0
Treatment Period Part A (Weeks 0 to 24) Withdrawal by Subject	15	5	12
Treatment Period Part A (Weeks 0 to 24) Randomized But Not Treated	1	1	0
Treatment Period Part B (Weeks 24 to 52) Adverse Event	10	16	5
Treatment Period Part B (Weeks 24 to 52) Death	1	0	1
Treatment Period Part B (Weeks 24 to 52) Lack of Efficacy	0	0	1
Treatment Period Part B (Weeks 24 to 52) Lost to Follow-up	0	0	1
Treatment Period Part B (Weeks 24 to 52) Physician Decision	0	1	0
Treatment Period Part B (Weeks 24 to 52) Sponsor Decision	1	2	0
Treatment Period Part B (Weeks 24 to 52) Withdrawal by Subject	4	3	7
Rescue Period Adverse Event	0	15	0
Rescue Period Death	0	1	0
Rescue Period Lack of Efficacy	0	7	0
Rescue Period Withdrawal by Subject	0	8	0

Baseline Characteristics

A Study in Moderate to Severe Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX) therapy throughout study.	Total n=1305 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 11.8 • n=5 Participants	53.5 years STANDARD_DEVIATION 12.2 • n=7 Participants	52.9 years STANDARD_DEVIATION 12.3 • n=5 Participants	53.3 years STANDARD_DEVIATION 12.1 • n=4 Participants
Sex: Female, Male Female	382 Participants n=5 Participants	375 Participants n=7 Participants	251 Participants n=5 Participants	1008 Participants n=4 Participants
Sex: Female, Male Male	106 Participants n=5 Participants	112 Participants n=7 Participants	79 Participants n=5 Participants	297 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	26 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	63 Participants n=4 Participants
Race (NIH/OMB) Asian	148 Participants n=5 Participants	143 Participants n=7 Participants	101 Participants n=5 Participants	392 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	302 Participants n=5 Participants	312 Participants n=7 Participants	204 Participants n=5 Participants	818 Participants n=4 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	11 Participants n=7 Participants	3 Participants n=5 Participants	21 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Argentina	91 Participants n=5 Participants	107 Participants n=7 Participants	57 Participants n=5 Participants	255 Participants n=4 Participants
Region of Enrollment Belgium	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment Canada	5 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment China	21 Participants n=5 Participants	22 Participants n=7 Participants	11 Participants n=5 Participants	54 Participants n=4 Participants
Region of Enrollment Croatia	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment Czechia	16 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	36 Participants n=4 Participants
Region of Enrollment France	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment Germany	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment Greece	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Hungary	18 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	37 Participants n=4 Participants
Region of Enrollment Japan	93 Participants n=5 Participants	93 Participants n=7 Participants	63 Participants n=5 Participants	249 Participants n=4 Participants
Region of Enrollment South Korea	21 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	57 Participants n=4 Participants
Region of Enrollment Latvia	2 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Region of Enrollment Lithuania	4 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	26 Participants n=4 Participants
Region of Enrollment Mexico	50 Participants n=5 Participants	36 Participants n=7 Participants	39 Participants n=5 Participants	125 Participants n=4 Participants
Region of Enrollment Poland	26 Participants n=5 Participants	35 Participants n=7 Participants	19 Participants n=5 Participants	80 Participants n=4 Participants
Region of Enrollment Portugal	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment Romania	8 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants
Region of Enrollment Russia	27 Participants n=5 Participants	28 Participants n=7 Participants	23 Participants n=5 Participants	78 Participants n=4 Participants
Region of Enrollment Slovakia	8 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Region of Enrollment Slovenia	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment South Africa	24 Participants n=5 Participants	21 Participants n=7 Participants	11 Participants n=5 Participants	56 Participants n=4 Participants
Region of Enrollment Spain	15 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment Taiwan	6 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Region of Enrollment United States	34 Participants n=5 Participants	36 Participants n=7 Participants	24 Participants n=5 Participants	94 Participants n=4 Participants
Duration of Rheumatoid Arthritis	10.4 years STANDARD_DEVIATION 8.7 • n=5 Participants	10.3 years STANDARD_DEVIATION 8.8 • n=7 Participants	9.6 years STANDARD_DEVIATION 8.5 • n=5 Participants	10.1 years STANDARD_DEVIATION 8.7 • n=4 Participants
Tender Joint Count of 68 Evaluable Joints	23.3 Number of Joints STANDARD_DEVIATION 13.5 • n=5 Participants	23.4 Number of Joints STANDARD_DEVIATION 13.0 • n=7 Participants	23.4 Number of Joints STANDARD_DEVIATION 13.7 • n=5 Participants	23.4 Number of Joints STANDARD_DEVIATION 13.3 • n=4 Participants
Swollen Joint Count of 66 Evaluable Joints	15.5 Number of Joints STANDARD_DEVIATION 9.4 • n=5 Participants	15.0 Number of Joints STANDARD_DEVIATION 8.2 • n=7 Participants	15.4 Number of Joints STANDARD_DEVIATION 9.1 • n=5 Participants	15.3 Number of Joints STANDARD_DEVIATION 8.9 • n=4 Participants
High Sensitivity C-Reactive Protein (hsCRP)	19.66 milligrams per liter (mg/L) STANDARD_DEVIATION 20.97 • n=5 Participants	22.20 milligrams per liter (mg/L) STANDARD_DEVIATION 22.85 • n=7 Participants	21.78 milligrams per liter (mg/L) STANDARD_DEVIATION 20.83 • n=5 Participants	21.14 milligrams per liter (mg/L) STANDARD_DEVIATION 21.67 • n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).

Outcome measures

Outcome measures
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)	40.2 percentage of participants	69.6 percentage of participants	61.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).

X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS. This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage. The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.

Outcome measures

Outcome measures
Measure	Placebo n=452 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=470 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=312 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in the Modified Total Sharp Score (mTSS)	0.84 units on a scale Standard Deviation 2.32	0.35 units on a scale Standard Deviation 1.59	0.29 units on a scale Standard Deviation 1.47

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: mITT population includes all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 \[without any difficulty\], 1 \[with some difficulty\], 2 \[with much difficulty\], and 3 \[unable to do\]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

Outcome measures

Outcome measures
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	-0.33 units on a scale Standard Deviation 0.51	-0.65 units on a scale Standard Deviation 0.59	-0.56 units on a scale Standard Deviation 0.54

SECONDARY outcome

Timeframe: Baseline, Week 12

Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.

Outcome measures

Outcome measures
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)	-1.01 units on a scale Standard Deviation 1.12	-2.27 units on a scale Standard Deviation 1.22	-1.98 units on a scale Standard Deviation 1.28

SECONDARY outcome

Timeframe: Week 12, Week 24, Week 52

Population: mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.

ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.

Outcome measures

Outcome measures
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response ACR50 Week 52	NA percentage of participants No data available. There is no Placebo Arm at week 52.	55.9 percentage of participants	47.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response ACR50 Week 12	16.8 percentage of participants	45.0 percentage of participants	34.8 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response ACR50 Week 24	19.3 percentage of participants	50.5 percentage of participants	45.5 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response ACR70 Week 12	4.7 percentage of participants	18.9 percentage of participants	12.7 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response ACR70 Week 24	8.0 percentage of participants	29.8 percentage of participants	21.8 percentage of participants
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response ACR70 Week 52	NA percentage of participants No data available. There is no Placebo Arm at week 52.	37.2 percentage of participants	30.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

Population: mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).

The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.

Outcome measures

Outcome measures
Measure	Placebo n=481 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=478 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=324 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Week 12	-13.53 units on a scale Standard Deviation 13.88	-23.00 units on a scale Standard Deviation 12.66	-20.42 units on a scale Standard Deviation 13.47
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Week 24	-14.21 units on a scale Standard Deviation 15.13	-25.04 units on a scale Standard Deviation 13.61	-22.92 units on a scale Standard Deviation 14.63
Change From Baseline in Clinical Disease Activity Index (CDAI) Score Week 52	NA units on a scale Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	-26.44 units on a scale Standard Deviation 14.42	-23.48 units on a scale Standard Deviation 15.28

SECONDARY outcome

Timeframe: Week 12, Week 24, Week 52

Population: mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.

SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.

Outcome measures

Outcome measures
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3 Week 24	3.1 percentage of participants	16.0 percentage of participants	13.6 percentage of participants
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3 Week 12	1.8 percentage of participants	8.4 percentage of participants	7.3 percentage of participants
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3 Week 52	NA percentage of participants NA= No data available. There is no Placebo Arm at week 52.	22.6 percentage of participants	17.9 percentage of participants

SECONDARY outcome

Timeframe: Week 12, Week 24, Week 52

The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.

Outcome measures

Outcome measures
Measure	Placebo n=488 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=487 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=330 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission Week 12	1.0 percentage of participants	7.2 percentage of participants	5.2 percentage of participants
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission Week 24	2.7 percentage of participants	12.1 percentage of participants	10.0 percentage of participants
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission Week 52	NA percentage of participants NA= No data available. There is no Placebo Arm at week 52.	15.6 percentage of participants	13.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.

Outcome measures

Outcome measures
Measure	Placebo n=479 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=323 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries	60.0 Minutes Interval 60.0 to 75.0	27.1 Minutes Interval 20.0 to 30.0	36.6 Minutes Interval 30.0 to 45.7

SECONDARY outcome

Timeframe: Week 12

Population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=479 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=323 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries	4.1 units on a scale Standard Deviation 2.3	3.0 units on a scale Standard Deviation 2.2	3.4 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Week 12

Population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.

Outcome measures

Outcome measures
Measure	Placebo n=479 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=323 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries	4.4 units on a scale Standard Deviation 2.3	3.6 units on a scale Standard Deviation 2.2	3.9 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Week 12

Population: mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.

Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=479 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=323 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries	4.6 units on a scale Standard Deviation 2.2	3.4 units on a scale Standard Deviation 2.2	4.0 units on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

Population: mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.

Outcome measures

Outcome measures
Measure	Placebo n=475 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=320 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores Week 12	6.8 units on a scale Standard Deviation 9.9	9.6 units on a scale Standard Deviation 10.4	9.5 units on a scale Standard Deviation 10.1
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores Week 24	6.6 units on a scale Standard Deviation 10.4	10.4 units on a scale Standard Deviation 10.8	9.9 units on a scale Standard Deviation 11.2
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores Week 52	NA units on a scale Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	10.8 units on a scale Standard Deviation 10.9	9.8 units on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental \[MCS\] and physical \[PCS\]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.

Outcome measures

Outcome measures
Measure	Placebo n=475 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=320 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) MCS Week 12	3.2 units on a scale Standard Deviation 10.3	3.3 units on a scale Standard Deviation 10.5	3.8 units on a scale Standard Deviation 10.8
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) MCS Week 24	2.2 units on a scale Standard Deviation 11.4	3.8 units on a scale Standard Deviation 10.9	3.9 units on a scale Standard Deviation 11.6
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) MCS Week 52	NA units on a scale Standard Deviation NA No data available. There is no Placebo Arm at week 52.	4.0 units on a scale Standard Deviation 10.8	3.7 units on a scale Standard Deviation 11.2
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) PCS Week 12	4.3 units on a scale Standard Deviation 7.1	8.9 units on a scale Standard Deviation 8.1	7.6 units on a scale Standard Deviation 8.2
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) PCS Week 24	4.6 units on a scale Standard Deviation 7.8	9.9 units on a scale Standard Deviation 8.2	8.3 units on a scale Standard Deviation 9.1
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute) PCS Week 52	NA units on a scale Standard Deviation NA No data available. There is no Placebo Arm at week 52.	10.4 units on a scale Standard Deviation 9.0	9.0 units on a scale Standard Deviation 9.2

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.

Outcome measures

Outcome measures
Measure	Placebo n=475 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=320 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Index Score (US Algorithm) Week 12	0.073 units on a scale Standard Deviation 0.151	0.132 units on a scale Standard Deviation 0.156	0.130 units on a scale Standard Deviation 0.159
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Index Score (US Algorithm) Week 24	0.065 units on a scale Standard Deviation 0.168	0.143 units on a scale Standard Deviation 0.168	0.137 units on a scale Standard Deviation 0.167
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Index Score (US Algorithm) Week 52	NA units on a scale Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	0.152 units on a scale Standard Deviation 0.163	0.141 units on a scale Standard Deviation 0.189
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Index Score (UK Algorithm) Week 12	0.107 units on a scale Standard Deviation 0.221	0.188 units on a scale Standard Deviation 0.228	0.186 units on a scale Standard Deviation 0.232
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Index Score (UK Algorithm) Week 24	0.094 units on a scale Standard Deviation 0.247	0.203 units on a scale Standard Deviation 0.244	0.195 units on a scale Standard Deviation 0.245
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Index Score (UK Algorithm) Week 52	NA units on a scale Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	0.215 units on a scale Standard Deviation 0.235	0.198 units on a scale Standard Deviation 0.273

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.

Outcome measures

Outcome measures
Measure	Placebo n=475 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=479 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=320 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) Self-Perceived Health Week 12	7.9 millimeter Standard Deviation 26.2	14.9 millimeter Standard Deviation 25.8	10.7 millimeter Standard Deviation 26.9
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) Self-Perceived Health Week 24	5.6 millimeter Standard Deviation 27.1	17.5 millimeter Standard Deviation 28.3	12.6 millimeter Standard Deviation 28.9
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) Self-Perceived Health Week 52	NA millimeter Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	19.9 millimeter Standard Deviation 28.0	13.3 millimeter Standard Deviation 29.7

SECONDARY outcome

Timeframe: Baseline, Week 12, Week 24, Week 52

Population: mITT population includes all randomized participants who received at least 1 dose of the study drug, with a baseline value and an observed value at the time point being summarized.

The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.

Outcome measures

Outcome measures
Measure	Placebo n=458 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=474 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=315 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Activity Impairment Week 24 (n=333,430,272)	-16 percentage of impairment Standard Deviation 26	-28 percentage of impairment Standard Deviation 27	-26 percentage of impairment Standard Deviation 26
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Work Productivity Loss Week 12 (n=147,160,113)	-10.4 percentage of impairment Standard Deviation 24.3	-21.6 percentage of impairment Standard Deviation 28.0	-14.0 percentage of impairment Standard Deviation 25.6
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Work Productivity Loss Week 24 (n=110,134,99)	-9.0 percentage of impairment Standard Deviation 24.9	-22.1 percentage of impairment Standard Deviation 30.2	-21.4 percentage of impairment Standard Deviation 27.2
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Work Productivity Loss Week 52 (n=0,119,88)	NA percentage of impairment Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	-24.4 percentage of impairment Standard Deviation 30.1	-24.6 percentage of impairment Standard Deviation 29.8
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Absenteeism Week 12 (n=160,168,118)	0.5 percentage of impairment Standard Deviation 27.7	-4.9 percentage of impairment Standard Deviation 20.6	-0.5 percentage of impairment Standard Deviation 25.7
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Absenteeism Week 24 (n=118,139,102)	-1.6 percentage of impairment Standard Deviation 24.5	-1.8 percentage of impairment Standard Deviation 25.2	-3.2 percentage of impairment Standard Deviation 23.8
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Absenteeism Week 52 (n=0,124,92)	NA percentage of impairment Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	-3.8 percentage of impairment Standard Deviation 25.1	-3.7 percentage of impairment Standard Deviation 24.3
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Presenteeism Week 12 (n=147,160,113)	-11 percentage of impairment Standard Deviation 23	-21 percentage of impairment Standard Deviation 26	-16 percentage of impairment Standard Deviation 24
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Presenteeism Week 24 (n=110,134,99)	-11 percentage of impairment Standard Deviation 22	-23 percentage of impairment Standard Deviation 27	-22 percentage of impairment Standard Deviation 26
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Presenteeism Week 52 (n=0,119,88)	NA percentage of impairment Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	-25 percentage of impairment Standard Deviation 27	-25 percentage of impairment Standard Deviation 27
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Activity Impairment Week 12 (n=458,474,315)	-11 percentage of impairment Standard Deviation 25	-25 percentage of impairment Standard Deviation 26	-20 percentage of impairment Standard Deviation 25
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores Activity Impairment Week 52 (n=0,396,240)	NA percentage of impairment Standard Deviation NA NA= No data available. There is no Placebo Arm at week 52.	-30 percentage of impairment Standard Deviation 27	-28 percentage of impairment Standard Deviation 27

SECONDARY outcome

Timeframe: Baseline, Week 24, Week 52

Population: mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.

X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).

Outcome measures

Outcome measures
Measure	Placebo n=452 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib n=473 Participants Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab n=312 Participants Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores Joint Space Narrowing Week 24 (n= 452, 470, 312)	0.27 units on a scale Standard Deviation 1.15	0.10 units on a scale Standard Deviation 0.74	0.09 units on a scale Standard Deviation 0.52
Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores Joint Space Narrowing Week 52 (n= 452, 473, 312)	0.56 units on a scale Standard Deviation 2.33	0.18 units on a scale Standard Deviation 1.02	0.17 units on a scale Standard Deviation 1.00
Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores Bone Erosion Score Week 24 (n=452, 470, 312)	0.57 units on a scale Standard Deviation 1.58	0.25 units on a scale Standard Deviation 1.12	0.20 units on a scale Standard Deviation 1.08
Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores Bone Erosion Score Week 52 (n= 452, 473, 312)	1.15 units on a scale Standard Deviation 3.21	0.42 units on a scale Standard Deviation 1.91	0.34 units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose

Population: All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.

Outcome measures

Outcome measures
Measure	Placebo n=635 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib	143 nanomole/Liter (nmol/L) Geometric Coefficient of Variation 19.7	—	—

SECONDARY outcome

Timeframe: Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 12; Week 24; Week 32: Pre-dose

Population: All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.

Outcome measures

Outcome measures
Measure	Placebo n=635 Participants Placebo administered orally once daily through Week 24 and placebo administered by SC injection every 2 weeks through Week 50. At Week 24, participants were switched to baricitinib 4 mg orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background MTX therapy throughout study.	Baricitinib Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.	Adalimumab Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background MTX therapy throughout study.
Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib	1220 nanomolehr/Liter (nmolhr/L) Geometric Coefficient of Variation 45.8	—	—

Adverse Events

Placebo Treatment A

Serious events: 26 serious events

Other events: 177 other events

Deaths: 0 deaths

Baricitinib Treatment A

Serious events: 26 serious events

Other events: 196 other events

Deaths: 0 deaths

Adalimumab Treatment A

Serious events: 7 serious events

Other events: 132 other events

Deaths: 0 deaths

Placebo Treatment B

Serious events: 12 serious events

Other events: 58 other events

Deaths: 0 deaths

BaricitinibTreatment B

Serious events: 16 serious events

Other events: 70 other events

Deaths: 0 deaths

Adalimumab Treatment B

Serious events: 9 serious events

Other events: 38 other events

Deaths: 0 deaths

Rescue

Serious events: 17 serious events

Other events: 46 other events

Deaths: 0 deaths

Placebo Follow-up

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Baricitinib Follow-up

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adalimumab Follow-up

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Treatment A n=488 participants at risk Placebo Treatment A (week 0-24). Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	Baricitinib Treatment A n=487 participants at risk Baricitinib Treatment A (week 0-24). Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.	Adalimumab Treatment A n=330 participants at risk Adalimumab Treatment A (week 0-24). Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	Placebo Treatment B n=306 participants at risk Placebo Treatment B (week 24-52). Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	BaricitinibTreatment B n=424 participants at risk Baricitinib Treatment B (week 24-52). Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.	Adalimumab Treatment B n=267 participants at risk Adalimumab Treatment B (week 24-52). Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	Rescue n=227 participants at risk Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).	Placebo Follow-up n=33 participants at risk No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.	Baricitinib Follow-up n=76 participants at risk No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Participants who were rescued or switched to Baricitinib 4 mg.	Adalimumab Follow-up n=20 participants at risk No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Blood and lymphatic system disorders Anaemia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.41% 2/487 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.88% 2/227 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Cardiac disorders Cardiac failure	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Cardiac disorders Myocardial infarction	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Cardiac disorders Sinus bradycardia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Blood and lymphatic system disorders Neutropenia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Cardiac disorders Acute myocardial infarction	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Cardiac disorders Supraventricular tachycardia	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Eye disorders Cataract	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Gastric ulcer	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Large intestine polyp	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Pancreatitis acute	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Eye disorders Macular fibrosis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Eye disorders Retinal detachment	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Diarrhoea	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Jejunal ulcer	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Hepatobiliary disorders Bile duct stone	0.41% 2/488 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Hepatobiliary disorders Cholangitis sclerosing	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Hepatobiliary disorders Cholelithiasis	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Arthritis infective	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Bronchitis	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Cellulitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.41% 2/487 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Disseminated tuberculosis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Epiglottitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Gastroenteritis	0.41% 2/488 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Herpes zoster	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.41% 2/487 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Kidney infection	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Muscle abscess	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Pneumonia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 1/33 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Pyelonephritis	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Urinary tract infection	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.47% 2/424 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Atypical pneumonia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Bacteraemia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Cholecystitis infective	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Cystitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Escherichia sepsis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Necrotising fasciitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Pneumonia pseudomonal	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Pyelonephritis acute	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Viral infection	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Joint injury	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Fall	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.65% 2/306 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Laceration	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Post concussion syndrome	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Investigations Alanine aminotransferase increased	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Investigations Aspartate aminotransferase increased	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Metabolism and nutrition disorders Dehydration	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Metabolism and nutrition disorders Diabetes mellitus	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Metabolism and nutrition disorders Hypoproteinaemia	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Back pain	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Osteoporosis	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.82% 4/488 • Number of events 4 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 1/33 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma stage III	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Nervous system disorders Transient ischaemic attack	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Psychiatric disorders Insomnia	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Psychiatric disorders Confusional state	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Renal and urinary disorders Acute kidney injury	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Renal and urinary disorders Calculus urinary	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Renal and urinary disorders Nephrosclerosis	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Renal and urinary disorders Renal impairment	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Nasal septum perforation	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.24% 1/424 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Surgical and medical procedures Hysterectomy	0.20% 1/488 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Surgical and medical procedures Bladder repair	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Surgical and medical procedures Fracture treatment	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Surgical and medical procedures Knee arthroplasty	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.33% 1/306 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Vascular disorders Circulatory collapse	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Vascular disorders Hypotension	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.30% 1/330 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Vascular disorders Thrombophlebitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.21% 1/487 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Arthritis bacterial	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Sepsis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 1/33 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Soft tissue infection	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Tuberculosis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoproliferative disorder	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Nervous system disorders Cerebrovascular accident	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Eye disorders Glaucoma	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Enterocolitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.88% 2/227 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Inguinal hernia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
General disorders Non-cardiac chest pain	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 1/33 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.44% 1/227 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.

Other adverse events

Other adverse events
Measure	Placebo Treatment A n=488 participants at risk Placebo Treatment A (week 0-24). Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	Baricitinib Treatment A n=487 participants at risk Baricitinib Treatment A (week 0-24). Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.	Adalimumab Treatment A n=330 participants at risk Adalimumab Treatment A (week 0-24). Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	Placebo Treatment B n=306 participants at risk Placebo Treatment B (week 24-52). Placebo administered orally (PO) once daily (QD) through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	BaricitinibTreatment B n=424 participants at risk Baricitinib Treatment B (week 24-52). Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52.	Adalimumab Treatment B n=267 participants at risk Adalimumab Treatment B (week 24-52). Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52.	Rescue n=227 participants at risk Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).	Placebo Follow-up n=33 participants at risk No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.	Baricitinib Follow-up n=76 participants at risk No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Participants who were rescued or switched to Baricitinib 4 mg.	Adalimumab Follow-up n=20 participants at risk No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
Blood and lymphatic system disorders Anaemia	3.1% 15/488 • Number of events 16 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.3% 16/487 • Number of events 16 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.2% 4/330 • Number of events 4 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.5% 8/227 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Diarrhoea	2.9% 14/488 • Number of events 16 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.3% 11/487 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.4% 8/330 • Number of events 10 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Dyspepsia	1.4% 7/488 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.8% 9/487 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.4% 8/330 • Number of events 8 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Nausea	1.2% 6/488 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.9% 14/487 • Number of events 15 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.7% 9/330 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Bronchitis	2.9% 14/488 • Number of events 14 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.9% 19/487 • Number of events 22 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.4% 8/330 • Number of events 8 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.6% 11/306 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.8% 12/424 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.9% 5/267 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.6% 6/227 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Influenza	0.82% 4/488 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.5% 12/487 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.5% 5/330 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.98% 3/306 • Number of events 3 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.4% 10/424 • Number of events 10 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.37% 1/267 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.2% 5/227 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Nasopharyngitis	7.2% 35/488 • Number of events 39 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	7.6% 37/487 • Number of events 41 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	10.3% 34/330 • Number of events 40 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	4.9% 15/306 • Number of events 19 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	5.7% 24/424 • Number of events 26 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	5.2% 14/267 • Number of events 15 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	4.0% 9/227 • Number of events 11 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	6.1% 2/33 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Pharyngitis	2.9% 14/488 • Number of events 14 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.5% 12/487 • Number of events 13 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.6% 12/330 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.3% 10/306 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.94% 4/424 • Number of events 4 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.6% 7/267 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.2% 5/227 • Number of events 10 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Upper respiratory tract infection	2.9% 14/488 • Number of events 15 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.1% 15/487 • Number of events 17 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.9% 13/330 • Number of events 16 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.3% 10/306 • Number of events 10 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.1% 13/424 • Number of events 13 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.5% 4/267 • Number of events 4 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.6% 6/227 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	10.0% 2/20 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Infections and infestations Urinary tract infection	3.3% 16/488 • Number of events 16 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	4.3% 21/487 • Number of events 25 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.9% 13/330 • Number of events 14 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.6% 5/306 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.4% 10/424 • Number of events 10 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.9% 5/267 • Number of events 6 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.2% 5/227 • Number of events 6 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Investigations Alanine aminotransferase increased	1.0% 5/488 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.6% 8/487 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.7% 9/330 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Investigations Blood creatine phosphokinase increased	0.61% 3/488 • Number of events 3 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.7% 13/487 • Number of events 15 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.61% 2/330 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.2% 5/227 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 7/488 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.1% 15/487 • Number of events 15 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.61% 2/330 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Metabolism and nutrition disorders Hyperlipidaemia	0.41% 2/488 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.1% 10/487 • Number of events 11 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.91% 3/330 • Number of events 3 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Back pain	1.6% 8/488 • Number of events 8 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.8% 9/487 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 10/330 • Number of events 13 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.3% 7/306 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.1% 9/424 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.5% 4/267 • Number of events 4 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	2.9% 14/488 • Number of events 15 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.0% 5/487 • Number of events 6 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.2% 4/330 • Number of events 5 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Nervous system disorders Headache	2.5% 12/488 • Number of events 12 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.9% 14/487 • Number of events 17 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.9% 13/330 • Number of events 16 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.5% 2/79 • Number of events 2 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Respiratory, thoracic and mediastinal disorders Cough	1.6% 8/488 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.4% 7/487 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.1% 7/330 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Skin and subcutaneous tissue disorders Rash	1.0% 5/488 • Number of events 6 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.62% 3/487 • Number of events 3 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.1% 7/330 • Number of events 7 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Vascular disorders Hypertension	2.7% 13/488 • Number of events 13 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	1.8% 9/487 • Number of events 9 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.3% 11/330 • Number of events 11 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Gastrointestinal disorders Constipation	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.2% 5/227 • Number of events 6 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 1/33 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.1% 1/47 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Reproductive system and breast disorders Calculus prostatic	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	2.1% 1/47 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Eye disorders Blepharitis	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	3.0% 1/33 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/20 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/488 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/487 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/330 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/306 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/424 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/267 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/227 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/33 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	0.00% 0/76 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.	6.2% 1/16 • Number of events 1 All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60