Rheumatoid Arthritis
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as baricitinib in participants with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate therapy.
Interventions
DRUGBaricitinib
Administered orally
DRUGPlacebo
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of adult-onset RA as defined by the ACR/European League Against Rheumatism (EULAR) 2010 Criteria for the Classification of RA. * Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints. * Have a CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if available). * Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.
Exclusion criteria
* Are currently receiving corticosteroids at doses \>10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization. * Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization. * Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs). * Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry. * Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide). * Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry. * Have ever received any biologic DMARD (such as tumor necrosis factor (TNF), interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies). * Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study. * Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization. * Have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout. * Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \<40 milliliters/minute/1.73 meters squared (m\^2). * Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal (ULN) or the most recent available total bilirubin 1.5 times the ULN. * Have a current or recent (\<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection. * Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV). * Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB. * Have evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment. * Are pregnant or nursing at the time of study entry. * Are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in intercourse while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product. * Are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product. * Have previously been randomized in this study or any other study investigating baricitinib. * Have received prior treatment with an oral janus kinase inhibitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) | Week 12 | ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP) | Baseline, Week 12 | Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). 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 from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition. |
| Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3 | Week 12 | 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), Participant'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. |
| Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12 | Week 12 | Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper 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. |
| Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score | Baseline, Week 12 | 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 HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition. |
| Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12 | Week 12 | 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 paper diaries. The average value across the 7 days preceding each visit is calculated. |
| Mean Worst Pain NRS in the 7 Days Prior to Week 12 | Week 12 | 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 paper diaries. The average value across the 7 days preceding each visit was calculated. |
| Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12 | Week 12 | 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 paper diaries. The average value across the 7 days preceding each visit was calculated. |
Countries
Argentina, Brazil, China
Participant flow
Pre-assignment details
Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment (Tx) beginning at Week 16. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52.
Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
Placebo: Administered orally | 145 |
| Baricitinib 4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks.
Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
Baricitinib: Administered orally | 145 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Follow-up Period | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| Follow-up Period | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-up Period | Sponsor Decision | 0 | 0 | 0 | 0 | 0 | 1 | 6 |
| Follow-up Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Open Label Period | Adverse Event | 0 | 0 | 0 | 2 | 2 | 0 | 0 |
| Open Label Period | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Open Label Period | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Rescue Period | Death | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Rescue Period | Lack of Efficacy | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Rescue Period | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Treatment Period Week 0-24 | Adverse Event | 3 | 2 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period Week 0-24 | Entry Criteria Not Met | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period Week 0-24 | Lack of Efficacy | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period Week 0-24 | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period Week 0-24 | Withdrawal by Subject | 7 | 5 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Baricitinib | Total |
|---|---|---|---|
| Age, Continuous | 48.9 years STANDARD_DEVIATION 12.7 | 49.5 years STANDARD_DEVIATION 10.6 | 49.2 years STANDARD_DEVIATION 11.7 |
| Duration of Rheumatoid Arthritis | 9.1 years STANDARD_DEVIATION 7 | 10.7 years STANDARD_DEVIATION 8.3 | 9.9 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 116 Participants | 231 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 30 Participants | 29 Participants | 59 Participants |
| High Sensitivity C-Reactive Protein (hsCRP) | 26.48 milligrams per liter (mg/L) STANDARD_DEVIATION 31.27 | 25.59 milligrams per liter (mg/L) STANDARD_DEVIATION 23.53 | 26.04 milligrams per liter (mg/L) STANDARD_DEVIATION 27.63 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 115 Participants | 116 Participants | 231 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 24 Participants | 50 Participants |
| Region of Enrollment Argentina | 22 Participants | 21 Participants | 43 Participants |
| Region of Enrollment Brazil | 8 Participants | 8 Participants | 16 Participants |
| Region of Enrollment China | 115 Participants | 116 Participants | 231 Participants |
| Sex: Female, Male Female | 106 Participants | 127 Participants | 233 Participants |
| Sex: Female, Male Male | 39 Participants | 18 Participants | 57 Participants |
| Swollen Joint Count of 66 Evaluable Joints | 14.8 Swollen Joints STANDARD_DEVIATION 9.5 | 14.6 Swollen Joints STANDARD_DEVIATION 8.6 | 14.7 Swollen Joints STANDARD_DEVIATION 9.1 |
| Tender Joint Count of 68 Evaluable Joints | 25.2 Tender Joints STANDARD_DEVIATION 14.7 | 23.3 Tender Joints STANDARD_DEVIATION 13.6 | 24.2 Tender Joints STANDARD_DEVIATION 14.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 145 | 1 / 77 | 0 / 74 | 0 / 120 | 0 / 2 | 0 / 58 |
| other Total, other adverse events | 72 / 145 | 94 / 145 | 38 / 77 | 31 / 74 | 41 / 120 | 0 / 2 | 3 / 58 |
| serious Total, serious adverse events | 4 / 145 | 4 / 145 | 3 / 77 | 7 / 74 | 3 / 120 | 0 / 2 | 1 / 58 |
Outcome results
Primary
Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) \* 100.
Time frame: Week 12
Population: All randomized participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) | 28.3 percentage of participants |
| Baricitinib | Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) | 58.6 percentage of participants |
p-value: 0.00195% CI: [2.5, 6.9]Regression, Logistic
Secondary
Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). 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 from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Time frame: Baseline, Week 12
Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP) | -0.94 units on a scale | Standard Deviation 1.04 |
| Baricitinib | Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP) | -1.89 units on a scale | Standard Deviation 1.14 |
p-value: 0.00195% CI: [-1.25, -0.79]ANCOVA
Secondary
Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score
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 HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Time frame: Baseline, Week 12
Population: All randomized participants who received at least one dose of the study drug and had an evaluable score at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score | -0.35 units on a scale | Standard Deviation 0.52 |
| Baricitinib | Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score | -0.57 units on a scale | Standard Deviation 0.54 |
p-value: 0.00195% CI: [-0.31, -0.09]ANCOVA
Secondary
Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12
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 paper diaries. The average value across the 7 days preceding each visit was calculated.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12 | 4.3 units on a scale | Standard Deviation 2.3 |
| Baricitinib | Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12 | 3.5 units on a scale | Standard Deviation 2.1 |
p-value: 0.00295% CI: [-1.2, -0.3]ANCOVA
Secondary
Mean Worst Pain NRS in the 7 Days Prior to Week 12
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 paper diaries. The average value across the 7 days preceding each visit was calculated.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug and had evaluable score at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Worst Pain NRS in the 7 Days Prior to Week 12 | 5.0 units on a scale | Standard Deviation 1.8 |
| Baricitinib | Mean Worst Pain NRS in the 7 Days Prior to Week 12 | 4.1 units on a scale | Standard Deviation 1.9 |
p-value: 0.00195% CI: [-1.3, -0.5]ANCOVA
Secondary
Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12
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 paper diaries. The average value across the 7 days preceding each visit is calculated.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12 | 4.4 units on a scale | Standard Deviation 2 |
| Baricitinib | Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12 | 3.7 units on a scale | Standard Deviation 1.9 |
p-value: 0.00195% CI: [-1.2, -0.4]ANCOVA
Secondary
Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12
Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper 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.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug and had an evaluable score at Week 12.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12 | 47.6 minutes |
| Baricitinib | Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12 | 24.3 minutes |
p-value: 0.00495% CI: [-28, -2.9]Wilcoxon (Mann-Whitney)
Secondary
Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3
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), Participant'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.
Time frame: Week 12
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3 | 0 Participants |
| Baricitinib | Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3 | 2 Participants |
95% CI: [-0.5, 3.3]