RA-BEAM: A Study in Moderate to Severe Rheumatoid Arthritis

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01710358
• Collaborator: (none)
• Enrollment: 1,307
• Locations: 213
• Arms: 3
• Duration (Months): 35
• Patients Per Site: 6.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Adalimumab; Drug: Baricitinib; Drug: Methotrexate; Drug: Adalimumab Placebo; Drug: Baricitinib Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1307 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 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.	Drug: Methotrexate; Administered orally; Drug: Adalimumab Placebo; Adalimumab placebo administered SC.; Drug: Baricitinib Placebo; Baricitinib placebo administered orally.
Experimental: 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 methotrexate (MTX) therapy throughout study.	Drug: Baricitinib; Administered orally; Other Names: LY 3009104 ; Drug: Methotrexate; Administered orally; Drug: Adalimumab Placebo; Adalimumab placebo administered SC.
Active Comparator: 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 methotrexate (MTX) therapy throughout study.	Drug: Adalimumab; Administered SC; Drug: Methotrexate; Administered orally; Drug: Baricitinib Placebo; Baricitinib placebo administered orally.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) [Week 12]

   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.

Secondary Outcome Measures

1. Change From Baseline in the Modified Total Sharp Score (mTSS) [Baseline, Week 24]

   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.

2. Change From Baseline 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 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.

3. Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-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 (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.

4. Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response [Week 12, Week 24, Week 52]

   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.

5. Change From Baseline in Clinical Disease Activity Index (CDAI) Score [Baseline, Week 12, Week 24, Week 52]

   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.

6. Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3 [Week 12, Week 24, Week 52]

   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.

7. Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission [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.

8. Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries [Week 12]

   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.

9. Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries [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 electronic diaries. The average value across the 7 days preceding each visit was calculated.

10. Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries [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 electronic diaries. The average value across the 7 days preceding each visit is calculated.

11. Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries [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 electronic diaries. The average value across the 7 days preceding each visit was calculated.

12. Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores [Baseline, Week 12, Week 24, Week 52]

    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.

13. 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) [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.

14. Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores [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.

15. Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health) [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.

16. Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores [Baseline, Week 12, Week 24, Week 52]

    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.

17. Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores [Baseline, Week 24, Week 52]

    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).

18. Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib [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]

19. Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/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 C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥6 milligram per Liter (mg/L)

• Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response.

• Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status

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 non-steroidal anti-inflammatory drugs (NSAIDs) 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 antirheumatic drugs (cDMARDs)

• Are currently receiving or have received cDMARDs (eg, 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 4 weeks prior to study entry

• Have received leflunomide in the 12 weeks prior to study entry

• Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry

• Have ever received any biologic disease-modifying antirheumatic drugs (DMARD)

• Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study

• 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 any condition or contraindication for adalimumab that would preclude the participant from participating in this protocol

• Have active fibromyalgia that would make it difficult to appropriately assess RA activity for the purposes of this study

• 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(participants with secondary Sjögren's syndrome are not excluded)

• Have a diagnosis of Felty's syndrome

• Have had any major surgery within 8 weeks prior to study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant

• Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure

• Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data

• Are largely or wholly incapacitated permitting little or no self-care, such as being bedridden or confined to a wheelchair

• have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years

• Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)

• Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection

• Have had symptomatic herpes zoster infection within 12 weeks prior to study entry

• Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, or postherpetic neuralgia)

• Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study

• Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

• Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study

• Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study

• Have symptomatic herpes simplex at the time of study enrollment

• Have evidence of active or latent tuberculosis (TB)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arthritis & Rheumatology Research	Glendale	Arizona	United States	85304
2	Sun Valley Arthritis Center, LTD	Peoria	Arizona	United States	85381
3	Valley Arthritis Care, LLC	Phoenix	Arizona	United States	85023
4	University of Boards Regent	Tucson	Arizona	United States	85724
5	Valley Endocrine, Fresno	Fresno	California	United States	93720
6	Desert Medical Advances	Palm Desert	California	United States	92260
7	Pacific Arthritis Center	Santa Maria	California	United States	93454
8	Inlande Rheumatology Clinical Trials	Upland	California	United States	91786
9	Boulder Medical Center	Boulder	Colorado	United States	80304
10	Clinical Research Center of CT/NY	Danbury	Connecticut	United States	06810
11	New England Research Associates	Trumbull	Connecticut	United States	06611
12	Delaware Arthritis	Lewes	Delaware	United States	19958
13	Orthopedic Research Institute	Boynton Beach	Florida	United States	33472
14	Jeffrey Alper, M.D.	Naples	Florida	United States	34102
15	Sun Coast Clinical Research, Inc	New Port Richey	Florida	United States	34652
16	Rheumatology Associates of Central Florida	Orlando	Florida	United States	32806
17	Integral Rheumatology & Immunology Specialists	Plantation	Florida	United States	33324
18	McIlwain Medical Group	Tampa	Florida	United States	33613
19	Indiana University Health	Indianapolis	Indiana	United States	46202
20	Diagnostic Rheumatology and Research	Indianapolis	Indiana	United States	46227
21	Goldpoint Clinical Research LLC	Indianapolis	Indiana	United States	46260
22	West Michigan Rheumatology	Grand Rapids	Michigan	United States	49546
23	University of Missouri	Columbia	Missouri	United States	65212
24	Dr. George Timothy Kelly	Las Vegas	Nevada	United States	89128
25	(AOA) Arthritis & Osteoporosis Associates	Freehold	New Jersey	United States	07728
26	Bio Behavioral Health	Toms River	New Jersey	United States	08755
27	Drug Trials of America	Hartsdale	New York	United States	10530
28	Asheville Rheumatology & Osteoporosis Research Assoc, PA	Asheville	North Carolina	United States	28803
29	Paramount Medical Research	Middleburg Heights	Ohio	United States	44130
30	Health Research Institute	Oklahoma City	Oklahoma	United States	73103
31	Healthcare Research Consultant	Tulsa	Oklahoma	United States	74135
32	Oregon Health and Science University	Portland	Oregon	United States	97239
33	East Penn Rheumatology	Bethlehem	Pennsylvania	United States	18017
34	Clinical Research Center of Reading, LLP	Wyomissing	Pennsylvania	United States	19610
35	Carolina Rheumatology and Neurology Associates	Myrtle Beach	South Carolina	United States	29572
36	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
37	Pioneer Research Solutions	Houston	Texas	United States	77008
38	Accurate Clinical Research	Houston	Texas	United States	77084
39	Arthritis & Osteoporosis Associates LLP	Lubbock	Texas	United States	79424
40	Accurate Clinical Research	Nassau Bay	Texas	United States	77058
41	Accurate Clinical Research	Webster	Texas	United States	77508
42	Center for Arthritis and Rheumatic Diseases, PC	Chesapeake	Virginia	United States	23320
43	The Seattle Arthritis Clinic	Seattle	Washington	United States	98133
44	Vancouver Clinic	Vancouver	Washington	United States	98664
45	Rheumatology and Immunotherapy Center	Franklin	Wisconsin	United States	53132
46	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bahia Blanca		Argentina	B8000HXM
47	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Buenos Aires		Argentina	CBA 1419
48	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Caba		Argentina	C1440AAD
49	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Córdoba		Argentina	5000
50	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mar Del Plata		Argentina	B7600FZN
51	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Quilmes		Argentina	B1878DVC
52	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Rosario		Argentina	2000
53	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Fernando		Argentina	1646
54	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Juan		Argentina	5400
55	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Miguel De Tucuman		Argentina	T4000AXL
56	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brussel		Belgium	1200
57	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Genk		Belgium	3600
58	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Merksem		Belgium	2170
59	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mons		Belgium	7000
60	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kelowna	British Columbia	Canada	V1Y3G8
61	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Victoria	British Columbia	Canada	V8V 3P9
62	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kitchener	Ontario	Canada	N2M 5N6
63	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	St. Catherines	Ontario	Canada	L2N 7E4
64	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Toronto	Ontario	Canada	M5T 3L9
65	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Trois-Rivieres	Quebec	Canada	G8Z 1Y2
66	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Beijing		China	100044
67	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bengbu		China	233004
68	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Changsha		China	410011
69	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Guang Zhou		China	510630
70	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hefei		China	230022
71	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Jinan		China	250012
72	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shanghai		China	200052
73	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Wu Han		China	430030
74	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Varazdin		Croatia	42000
75	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Zagreb		Croatia	10 000
76	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brno		Czechia	61141
77	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bruntal		Czechia	79201
78	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hustopece		Czechia	693 01
79	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ostrava - Trebovice		Czechia	722 00
80	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ostrava		Czechia	702 00
81	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pardubice		Czechia	530 02
82	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Prague		Czechia	128 50
83	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Uherske Hradiste		Czechia	686 01
84	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Zlin		Czechia	760 01
85	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cahors Cedex 9		France	46005
86	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Limoges		France	87042
87	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Montpellier		France	34295
88	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nantes		France	44093
89	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Orleans		France	45032
90	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Paris		France	75679
91	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Poitiers		France	86021
92	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Strasbourg		France	67098
93	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Thionville		France	57100
94	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tours		France	37044
95	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gommern		Germany	39245
96	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Herne		Germany	44649
97	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Köln		Germany	50937
98	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Würzburg		Germany	97080
99	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Athens		Greece	11527
100	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Heraklion		Greece	71110
101	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Larissa		Greece	41221
102	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Marousi		Greece	14561
103	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Budapest		Hungary	1023
104	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kiskunhalas		Hungary	6400
105	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nyiregyhaza		Hungary	4400
106	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Szekesfehervar		Hungary	8000
107	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Veszprem		Hungary	8200
108	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aichi		Japan	450-0002
109	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Chiba		Japan	284-0003
110	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Fukuoka		Japan	814-0002
111	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hiroshima		Japan	730-0017
112	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hokkaido		Japan	063-0811
113	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hyogo		Japan	665-0827
114	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ibaragi		Japan	316-0015
115	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ibaraki		Japan	305-8576
116	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Iwate		Japan	020-0034
117	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Japan		Japan	275-8580
118	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kagawa		Japan	761-0793
119	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kagoshima		Japan	211-0063
120	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kanagawa		Japan	224-0041
121	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kumamoto		Japan	862-8655
122	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mie		Japan	510-0016
123	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagano		Japan	380-8582
124	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nagasaki		Japan	850-0832
125	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Niigata		Japan	957-0054
126	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Oita		Japan	870-0823
127	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Okayama		Japan	700-0013
128	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Okinawa		Japan	901-0243
129	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Osaka		Japan	545-0011
130	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saga		Japan	843-0393
131	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saitama		Japan	333-0833
132	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Shizuoka		Japan	420-0821
133	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tochigi		Japan	329- 0498
134	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tokyo		Japan	160-8582
135	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Toyama		Japan	933-0874
136	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Yamaguchi		Japan	745-0824
137	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Daegu		Korea, Republic of	700-712
138	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Daejeon		Korea, Republic of	301-721
139	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gwangju		Korea, Republic of	510-757
140	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Incheon		Korea, Republic of	400-711
141	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Seoul		Korea, Republic of	130-702
142	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Suwon-Si		Korea, Republic of	443-721
143	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Liepaja		Latvia	LV-3401
144	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Riga		Latvia	LV-1002
145	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Valmiera		Latvia	LV-4201
146	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kaunas		Lithuania	LT-50128
147	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Klaipeda		Lithuania	LT-92288
148	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Siauliai		Lithuania	76231
149	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Guadalajara		Mexico	44690
150	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Merida		Mexico	97070
151	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mexicali		Mexico	21200
152	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Mexico		Mexico	06600
153	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	San Luis Potosi		Mexico	78213
154	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Tijuana		Mexico	22010
155	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bydgoszcz		Poland	85-168
156	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Elblag		Poland	82-300
157	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Gdansk		Poland	80-546
158	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Katowice		Poland	40-084
159	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lodz		Poland	90-242
160	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Nadarzyn		Poland	05-830
161	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Warszawa		Poland	02-653
162	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lisbon		Portugal	1050
163	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Porto		Portugal	4200-319
164	Ramon L. Ortega Colon	Carolina		Puerto Rico	00983
165	Office of Dr. Ramon Toro	San German		Puerto Rico	00683
166	Mindful Medical Research	San Juan		Puerto Rico	00918
167	Latin Clinical Trial Center	Santurce		Puerto Rico	00909
168	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bucharest		Romania	10584
169	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Cluj-Napoca		Romania	400006
170	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Constanta		Romania	900591
171	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Lasi		Romania	700661
172	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Oradea		Romania	410028
173	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Targu Mures		Romania	540136
174	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Korolev		Russian Federation	141060
175	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Moscow		Russian Federation	115522
176	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ryazan		Russian Federation	390026
177	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saint Petersburg		Russian Federation	194291
178	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Saratov		Russian Federation	410053
179	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ulyanovsk		Russian Federation	432063
180	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Yaroslavl		Russian Federation	150003
181	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bratislava		Slovakia	84231
182	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Partizanske		Slovakia	95801
183	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Spisska Nova Ves		Slovakia	052 01
184	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Topolcany		Slovakia	95501
185	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Ljubljana		Slovenia	1000
186	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Maribor		Slovenia	2000
187	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Durban		South Africa	4001
188	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Greenacres		South Africa	6057
189	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Pinelands		South Africa	7405
190	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Stellenbosch		South Africa	7600
191	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08025
192	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bilbao		Spain	48013
193	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Hospitalet De Llobregat		Spain	08907
194	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madrid		Spain	28040
195	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sabadell		Spain	08208
196	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Santander		Spain	39008
197	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Sevilla		Spain	41010
198	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Valencia		Spain	46026
199	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Villajoyosa		Spain	03570
200	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Fribourg		Switzerland	1708
201	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Kaohsiung City		Taiwan	83301
202	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Neihu Taipei		Taiwan	114
203	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taichung City		Taiwan	40201
204	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taichung		Taiwan	404
205	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Taipei		Taiwan	10630
206	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Yongkang City		Taiwan	71004
207	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London	England	United Kingdom	SE1 9RT
208	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London	Greater London	United Kingdom	E11 1NR
209	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Basingstoke	Hampshire	United Kingdom	RG24 9NA
210	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Southampton	Hants	United Kingdom	SO16 6YD
211	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Aberdeen	Scotland	United Kingdom	AB25 2ZN
212	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	North Shields	Tyneside	United Kingdom	NE29 8NH
213	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Bradford	West Yorkshire	United Kingdom	BD5 0NA

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01710358
• Other Study ID Numbers: 13978; I4V-MC-JADV
• First Posted: Oct 19, 2012
• Last Update Posted: Sep 18, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Adalimumab; Methotrexate

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Period Title: Treatment Period Part A (Weeks 0 to 24)
STARTED	489	488	330
Received at Least 1 Dose of Study Drug	488	487	330
Rescued	128	35	40
COMPLETED	438	459	307
NOT COMPLETED	51	29	23
Period Title: Treatment Period Part A (Weeks 0 to 24)
STARTED	310	424	267
Received at Least 1 Dose of Study Drug	306	424	267
Rescued	5	8	11
COMPLETED	294	402	252
NOT COMPLETED	16	22	15
Period Title: Treatment Period Part A (Weeks 0 to 24)
STARTED	0	227	0
COMPLETED	0	196	0
NOT COMPLETED	0	31	0
Period Title: Treatment Period Part A (Weeks 0 to 24)
STARTED	33	76	20
COMPLETED	33	76	20
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	Baricitinib	Adalimumab	Total
Arm/Group Description	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 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 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 of all reporting groups
Overall Participants	488	487	330	1305
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (11.8)	53.5 (12.2)	52.9 (12.3)	53.3 (12.1)
Sex: Female, Male (Count of Participants)
Female	382 78.3%	375 77%	251 76.1%	1008 77.2%
Male	106 21.7%	112 23%	79 23.9%	297 22.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	26 5.3%	19 3.9%	18 5.5%	63 4.8%
Asian	148 30.3%	143 29.4%	101 30.6%	392 30%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	4 0.8%	2 0.4%	4 1.2%	10 0.8%
White	302 61.9%	312 64.1%	204 61.8%	818 62.7%
More than one race	7 1.4%	11 2.3%	3 0.9%	21 1.6%
Unknown or Not Reported	1 0.2%	0 0%	0 0%	1 0.1%
Region of Enrollment (Count of Participants)
Argentina	91 18.6%	107 22%	57 17.3%	255 19.5%
Belgium	2 0.4%	3 0.6%	3 0.9%	8 0.6%
Canada	5 1%	4 0.8%	2 0.6%	11 0.8%
China	21 4.3%	22 4.5%	11 3.3%	54 4.1%
Croatia	1 0.2%	0 0%	0 0%	1 0.1%
Czechia	16 3.3%	10 2.1%	10 3%	36 2.8%
France	8 1.6%	8 1.6%	7 2.1%	23 1.8%
Germany	0 0%	0 0%	2 0.6%	2 0.2%
Greece	1 0.2%	0 0%	2 0.6%	3 0.2%
Hungary	18 3.7%	11 2.3%	8 2.4%	37 2.8%
Japan	93 19.1%	93 19.1%	63 19.1%	249 19.1%
South Korea	21 4.3%	21 4.3%	15 4.5%	57 4.4%
Latvia	2 0.4%	2 0.4%	5 1.5%	9 0.7%
Lithuania	4 0.8%	12 2.5%	10 3%	26 2%
Mexico	50 10.2%	36 7.4%	39 11.8%	125 9.6%
Poland	26 5.3%	35 7.2%	19 5.8%	80 6.1%
Portugal	1 0.2%	1 0.2%	1 0.3%	3 0.2%
Romania	8 1.6%	6 1.2%	2 0.6%	16 1.2%
Russia	27 5.5%	28 5.7%	23 7%	78 6%
Slovakia	8 1.6%	8 1.6%	4 1.2%	20 1.5%
Slovenia	4 0.8%	1 0.2%	0 0%	5 0.4%
South Africa	24 4.9%	21 4.3%	11 3.3%	56 4.3%
Spain	15 3.1%	11 2.3%	5 1.5%	31 2.4%
Taiwan	6 1.2%	5 1%	7 2.1%	18 1.4%
United Kingdom	2 0.4%	6 1.2%	0 0%	8 0.6%
United States	34 7%	36 7.4%	24 7.3%	94 7.2%
Duration of Rheumatoid Arthritis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.4 (8.7)	10.3 (8.8)	9.6 (8.5)	10.1 (8.7)
Tender Joint Count of 68 Evaluable Joints (Number of Joints) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of Joints]	23.3 (13.5)	23.4 (13.0)	23.4 (13.7)	23.4 (13.3)
Swollen Joint Count of 66 Evaluable Joints (Number of Joints) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of Joints]	15.5 (9.4)	15.0 (8.2)	15.4 (9.1)	15.3 (8.9)
High Sensitivity C-Reactive Protein (hsCRP) (milligrams per liter (mg/L)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [milligrams per liter (mg/L)]	19.66 (20.97)	22.20 (22.85)	21.78 (20.83)	21.14 (21.67)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	488	487	330
Number [percentage of participants]	40.2 8.2%	69.6 14.3%	61.2 18.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baricitinib
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Logistic
	Comments

2. Secondary Outcome

Title	Change From Baseline in the Modified Total Sharp Score (mTSS)
Description	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.
Time Frame	Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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 are were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants will continued to take background MTX therapy throughout study.
Measure Participants	452	470	312
Mean (Standard Deviation) [units on a scale]	0.84 (2.32)	0.35 (1.59)	0.29 (1.47)

3. Secondary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 will continue to receive baricitinib 4 mg administered orally once daily through Week 52. Participants will continue to take background MTX therapy throughout study.	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 are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 52. Participants will continue to take background MTX therapy throughout study.
Measure Participants	488	487	330
Mean (Standard Deviation) [units on a scale]	-0.33 (0.51)	-0.65 (0.59)	-0.56 (0.54)

4. Secondary Outcome

Title	Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Description	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.
Time Frame	Baseline, Week 12

Outcome Measure Data

Analysis Population Description

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 mBOCF.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	488	487	330
Mean (Standard Deviation) [units on a scale]	-1.01 (1.12)	-2.27 (1.22)	-1.98 (1.28)

5. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
Description	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.
Time Frame	Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	488	487	330
ACR50 Week 12	16.8 3.4%	45.0 9.2%	34.8 10.5%
ACR50 Week 24	19.3 4%	50.5 10.4%	45.5 13.8%
ACR50 Week 52	NA NaN	55.9 11.5%	47.0 14.2%
ACR70 Week 12	4.7 1%	18.9 3.9%	12.7 3.8%
ACR70 Week 24	8.0 1.6%	29.8 6.1%	21.8 6.6%
ACR70 Week 52	NA NaN	37.2 7.6%	30.6 9.3%

6. Secondary Outcome

Title	Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Description	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.
Time Frame	Baseline, Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	481	478	324
Week 12	-13.53 (13.88)	-23.00 (12.66)	-20.42 (13.47)
Week 24	-14.21 (15.13)	-25.04 (13.61)	-22.92 (14.63)
Week 52	NA (NA)	-26.44 (14.42)	-23.48 (15.28)

7. Secondary Outcome

Title	Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3
Description	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.
Time Frame	Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	488	487	330
Week 12	1.8 0.4%	8.4 1.7%	7.3 2.2%
Week 24	3.1 0.6%	16.0 3.3%	13.6 4.1%
Week 52	NA NaN	22.6 4.6%	17.9 5.4%

8. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
Description	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.
Time Frame	Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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. Baricitinib: Administered orally	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.
Measure Participants	488	487	330
Week 12	1.0 0.2%	7.2 1.5%	5.2 1.6%
Week 24	2.7 0.6%	12.1 2.5%	10.0 3%
Week 52	NA NaN	15.6 3.2%	13.0 3.9%

9. Secondary Outcome

Title	Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	479	479	323
Median (95% Confidence Interval) [Minutes]	60.0	27.1	36.6

10. Secondary Outcome

Title	Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	479	479	323
Mean (Standard Deviation) [units on a scale]	4.1 (2.3)	3.0 (2.2)	3.4 (2.3)

11. Secondary Outcome

Title	Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	479	479	323
Mean (Standard Deviation) [units on a scale]	4.4 (2.3)	3.6 (2.2)	3.9 (2.3)

12. Secondary Outcome

Title	Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	479	479	323
Mean (Standard Deviation) [units on a scale]	4.6 (2.2)	3.4 (2.2)	4.0 (2.3)

13. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores
Description	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.
Time Frame	Baseline, Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	475	479	320
Week 12	6.8 (9.9)	9.6 (10.4)	9.5 (10.1)
Week 24	6.6 (10.4)	10.4 (10.8)	9.9 (11.2)
Week 52	NA (NA)	10.8 (10.9)	9.8 (10.8)

14. Secondary Outcome

Title	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)
Description	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.
Time Frame	Baseline, Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	475	479	320
MCS Week 12	3.2 (10.3)	3.3 (10.5)	3.8 (10.8)
MCS Week 24	2.2 (11.4)	3.8 (10.9)	3.9 (11.6)
MCS Week 52	NA (NA)	4.0 (10.8)	3.7 (11.2)
PCS Week 12	4.3 (7.1)	8.9 (8.1)	7.6 (8.2)
PCS Week 24	4.6 (7.8)	9.9 (8.2)	8.3 (9.1)
PCS Week 52	NA (NA)	10.4 (9.0)	9.0 (9.2)

15. Secondary Outcome

Title	Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
Description	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.
Time Frame	Baseline, Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	475	479	320
Index Score (US Algorithm) Week 12	0.073 (0.151)	0.132 (0.156)	0.130 (0.159)
Index Score (US Algorithm) Week 24	0.065 (0.168)	0.143 (0.168)	0.137 (0.167)
Index Score (US Algorithm) Week 52	NA (NA)	0.152 (0.163)	0.141 (0.189)
Index Score (UK Algorithm) Week 12	0.107 (0.221)	0.188 (0.228)	0.186 (0.232)
Index Score (UK Algorithm) Week 24	0.094 (0.247)	0.203 (0.244)	0.195 (0.245)
Index Score (UK Algorithm) Week 52	NA (NA)	0.215 (0.235)	0.198 (0.273)

16. Secondary Outcome

Title	Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
Description	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.
Time Frame	Baseline, Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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 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.
Measure Participants	475	479	320
Self-Perceived Health Week 12	7.9 (26.2)	14.9 (25.8)	10.7 (26.9)
Self-Perceived Health Week 24	5.6 (27.1)	17.5 (28.3)	12.6 (28.9)
Self-Perceived Health Week 52	NA (NA)	19.9 (28.0)	13.3 (29.7)

17. Secondary Outcome

Title	Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
Description	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.
Time Frame	Baseline, Week 12, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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. Baricitinib: Administered orally	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.
Measure Participants	458	474	315
Absenteeism Week 12 (n=160,168,118)	0.5 (27.7)	-4.9 (20.6)	-0.5 (25.7)
Absenteeism Week 24 (n=118,139,102)	-1.6 (24.5)	-1.8 (25.2)	-3.2 (23.8)
Absenteeism Week 52 (n=0,124,92)	NA (NA)	-3.8 (25.1)	-3.7 (24.3)
Presenteeism Week 12 (n=147,160,113)	-11 (23)	-21 (26)	-16 (24)
Presenteeism Week 24 (n=110,134,99)	-11 (22)	-23 (27)	-22 (26)
Presenteeism Week 52 (n=0,119,88)	NA (NA)	-25 (27)	-25 (27)
Work Productivity Loss Week 12 (n=147,160,113)	-10.4 (24.3)	-21.6 (28.0)	-14.0 (25.6)
Work Productivity Loss Week 24 (n=110,134,99)	-9.0 (24.9)	-22.1 (30.2)	-21.4 (27.2)
Work Productivity Loss Week 52 (n=0,119,88)	NA (NA)	-24.4 (30.1)	-24.6 (29.8)
Activity Impairment Week 12 (n=458,474,315)	-11 (25)	-25 (26)	-20 (25)
Activity Impairment Week 24 (n=333,430,272)	-16 (26)	-28 (27)	-26 (26)
Activity Impairment Week 52 (n=0,396,240)	NA (NA)	-30 (27)	-28 (27)

18. Secondary Outcome

Title	Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores
Description	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).
Time Frame	Baseline, Week 24, Week 52

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Placebo	Baricitinib	Adalimumab
Arm/Group Description	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 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. Baricitinib: Administered orally	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.
Measure Participants	452	473	312
Joint Space Narrowing Week 24 (n= 452, 470, 312)	0.27 (1.15)	0.10 (0.74)	0.09 (0.52)
Joint Space Narrowing Week 52 (n= 452, 473, 312)	0.56 (2.33)	0.18 (1.02)	0.17 (1.00)
Bone Erosion Score Week 24 (n=452, 470, 312)	0.57 (1.58)	0.25 (1.12)	0.20 (1.08)
Bone Erosion Score Week 52 (n= 452, 473, 312)	1.15 (3.21)	0.42 (1.91)	0.34 (2.00)

19. Secondary Outcome

Title	Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baricitinib
Arm/Group Description	Baricitinib 4 mg administered orally once daily through Week 52
Measure Participants	635
Geometric Mean (Geometric Coefficient of Variation) [nanomole/Liter (nmol/L)]	143 (19.7)

20. Secondary Outcome

Title	Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Baricitinib
Arm/Group Description	Baricitinib 4 mg administered orally once daily through Week 52
Measure Participants	635
Geometric Mean (Geometric Coefficient of Variation) [nanomole*hr/Liter (nmol*hr/L)]	1220 (45.8)

Adverse Events

Adverse Event Reporting Description	All enrolled participants including rescue therapy. After Week 16, rescue therapy will be offered at the discretion of the investigator based on tender joint count and swollen joint count.
Arm/Group Title	Placebo Treatment A		Baricitinib Treatment A		Adalimumab Treatment A		Placebo Treatment B		BaricitinibTreatment B		Adalimumab Treatment B		Rescue		Placebo Follow-up		Baricitinib Follow-up		Adalimumab Follow-up
Arm/Group Description	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 (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 (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 (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.		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 (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.		Baricitinib 4 mg administered PO QD through Week 52 (Week 16-52).		No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.		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.		No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
All Cause Mortality
	Placebo Treatment A		Baricitinib Treatment A		Adalimumab Treatment A		Placebo Treatment B		BaricitinibTreatment B		Adalimumab Treatment B		Rescue		Placebo Follow-up		Baricitinib Follow-up		Adalimumab Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Treatment A		Baricitinib Treatment A		Adalimumab Treatment A		Placebo Treatment B		BaricitinibTreatment B		Adalimumab Treatment B		Rescue		Placebo Follow-up		Baricitinib Follow-up		Adalimumab Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	26/488 (5.3%)		26/487 (5.3%)		7/330 (2.1%)		12/306 (3.9%)		16/424 (3.8%)		9/267 (3.4%)		17/227 (7.5%)		2/33 (6.1%)		0/76 (0%)		0/20 (0%)
Blood and lymphatic system disorders
Anaemia	0/488 (0%)	0	2/487 (0.4%)	2	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	2/227 (0.9%)	2	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Lymphocytosis	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Neutropenia	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cardiac disorders
Cardiac failure	1/488 (0.2%)	1	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Myocardial infarction	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Sinus bradycardia	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Acute myocardial infarction	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Supraventricular tachycardia	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Eye disorders
Cataract	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Macular fibrosis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Retinal detachment	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Glaucoma	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Gastrointestinal disorders
Duodenal ulcer haemorrhage	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Gastric ulcer	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Gastrointestinal haemorrhage	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Large intestine polyp	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pancreatitis acute	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Diarrhoea	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Jejunal ulcer	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Enterocolitis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	2/227 (0.9%)	2	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Inguinal hernia	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
General disorders
Non-cardiac chest pain	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Hepatobiliary disorders
Bile duct stone	2/488 (0.4%)	2	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cholangitis sclerosing	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cholelithiasis	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Drug-induced liver injury	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Infections and infestations
Arthritis infective	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Bronchitis	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cellulitis	0/488 (0%)	0	2/487 (0.4%)	2	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Disseminated tuberculosis	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Epiglottitis	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Gastroenteritis	2/488 (0.4%)	2	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Herpes zoster	0/488 (0%)	0	2/487 (0.4%)	2	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Kidney infection	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Muscle abscess	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pneumonia	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	1/33 (3%)	1	0/76 (0%)	0	0/20 (0%)	0
Pyelonephritis	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Urinary tract infection	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	2/424 (0.5%)	2	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Atypical pneumonia	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Bacteraemia	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cholecystitis infective	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cystitis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Escherichia sepsis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Necrotising fasciitis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pneumonia pseudomonal	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pyelonephritis acute	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Viral infection	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Arthritis bacterial	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Sepsis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	1/33 (3%)	1	0/76 (0%)	0	0/20 (0%)	0
Soft tissue infection	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Tuberculosis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Injury, poisoning and procedural complications
Ankle fracture	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Femoral neck fracture	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Humerus fracture	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Joint injury	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Ulna fracture	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Fall	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	2/306 (0.7%)	2	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Femur fracture	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Laceration	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Post concussion syndrome	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Radius fracture	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Road traffic accident	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Spinal compression fracture	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Spinal fracture	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Investigations
Alanine aminotransferase increased	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Aspartate aminotransferase increased	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Metabolism and nutrition disorders
Dehydration	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Diabetes mellitus	1/488 (0.2%)	1	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Hypoproteinaemia	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Diabetes mellitus inadequate control	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
Arthralgia	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Back pain	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Chondrocalcinosis pyrophosphate	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Intervertebral disc protrusion	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Osteoporosis	1/488 (0.2%)	1	1/487 (0.2%)	1	0/330 (0%)	0	1/306 (0.3%)	1	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Rheumatoid arthritis	4/488 (0.8%)	4	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	1/33 (3%)	1	0/76 (0%)	0	0/20 (0%)	0
Bursitis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Myositis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Osteoarthritis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Lung squamous cell carcinoma stage III	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Ovarian cancer	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Uterine leiomyoma	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Clear cell renal cell carcinoma	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Lymphoproliferative disorder	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Squamous cell carcinoma of lung	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Nervous system disorders
Transient ischaemic attack	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Cerebrovascular accident	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Psychiatric disorders
Insomnia	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Confusional state	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Generalised anxiety disorder	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Renal and urinary disorders
Acute kidney injury	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Calculus urinary	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Nephrosclerosis	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/227 (0.4%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Renal impairment	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Reproductive system and breast disorders
Metrorrhagia	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	0/488 (0%)	0	1/487 (0.2%)	1	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Interstitial lung disease	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Nasal septum perforation	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Acute respiratory failure	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pleurisy	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pneumonia aspiration	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Pneumonitis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	1/424 (0.2%)	1	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Respiratory failure	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	1/33 (3%)	1	0/76 (0%)	0	0/20 (0%)	0
Skin and subcutaneous tissue disorders
Dermatitis allergic	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Surgical and medical procedures
Hysterectomy	1/488 (0.2%)	1	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Bladder repair	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Fracture treatment	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Knee arthroplasty	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	1/306 (0.3%)	1	0/424 (0%)	0	1/267 (0.4%)	1	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Vascular disorders
Circulatory collapse	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Hypotension	0/488 (0%)	0	0/487 (0%)	0	1/330 (0.3%)	1	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Thrombophlebitis	0/488 (0%)	0	1/487 (0.2%)	1	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Other (Not Including Serious) Adverse Events
	Placebo Treatment A		Baricitinib Treatment A		Adalimumab Treatment A		Placebo Treatment B		BaricitinibTreatment B		Adalimumab Treatment B		Rescue		Placebo Follow-up		Baricitinib Follow-up		Adalimumab Follow-up
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	177/488 (36.3%)		196/487 (40.2%)		132/330 (40%)		58/306 (19%)		70/424 (16.5%)		38/267 (14.2%)		46/227 (20.3%)		3/33 (9.1%)		0/76 (0%)		3/20 (15%)
Blood and lymphatic system disorders
Anaemia	15/488 (3.1%)	16	16/487 (3.3%)	16	4/330 (1.2%)	4	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	8/227 (3.5%)	9	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Eye disorders
Blepharitis	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	1/33 (3%)	1	0/76 (0%)	0	0/20 (0%)	0
Gastrointestinal disorders
Diarrhoea	14/488 (2.9%)	16	11/487 (2.3%)	12	8/330 (2.4%)	10	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Dyspepsia	7/488 (1.4%)	7	9/487 (1.8%)	9	8/330 (2.4%)	8	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Nausea	6/488 (1.2%)	7	14/487 (2.9%)	15	9/330 (2.7%)	9	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Constipation	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	5/227 (2.2%)	6	1/33 (3%)	1	0/76 (0%)	0	0/20 (0%)	0
Infections and infestations
Bronchitis	14/488 (2.9%)	14	19/487 (3.9%)	22	8/330 (2.4%)	8	11/306 (3.6%)	12	12/424 (2.8%)	12	5/267 (1.9%)	5	6/227 (2.6%)	7	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Influenza	4/488 (0.8%)	5	12/487 (2.5%)	12	5/330 (1.5%)	5	3/306 (1%)	3	10/424 (2.4%)	10	1/267 (0.4%)	1	5/227 (2.2%)	5	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Nasopharyngitis	35/488 (7.2%)	39	37/487 (7.6%)	41	34/330 (10.3%)	40	15/306 (4.9%)	19	24/424 (5.7%)	26	14/267 (5.2%)	15	9/227 (4%)	11	2/33 (6.1%)	2	0/76 (0%)	0	0/20 (0%)	0
Pharyngitis	14/488 (2.9%)	14	12/487 (2.5%)	13	12/330 (3.6%)	12	10/306 (3.3%)	12	4/424 (0.9%)	4	7/267 (2.6%)	7	5/227 (2.2%)	10	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Upper respiratory tract infection	14/488 (2.9%)	15	15/487 (3.1%)	17	13/330 (3.9%)	16	10/306 (3.3%)	10	13/424 (3.1%)	13	4/267 (1.5%)	4	6/227 (2.6%)	7	0/33 (0%)	0	0/76 (0%)	0	2/20 (10%)	2
Urinary tract infection	16/488 (3.3%)	16	21/487 (4.3%)	25	13/330 (3.9%)	14	5/306 (1.6%)	5	10/424 (2.4%)	10	5/267 (1.9%)	6	5/227 (2.2%)	6	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Investigations
Alanine aminotransferase increased	5/488 (1%)	5	8/487 (1.6%)	9	9/330 (2.7%)	9	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Blood creatine phosphokinase increased	3/488 (0.6%)	3	13/487 (2.7%)	15	2/330 (0.6%)	2	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	5/227 (2.2%)	5	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Metabolism and nutrition disorders
Hypercholesterolaemia	7/488 (1.4%)	7	15/487 (3.1%)	15	2/330 (0.6%)	2	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Hyperlipidaemia	2/488 (0.4%)	2	10/487 (2.1%)	11	3/330 (0.9%)	3	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	8/488 (1.6%)	8	9/487 (1.8%)	9	10/330 (3%)	13	7/306 (2.3%)	7	9/424 (2.1%)	9	4/267 (1.5%)	4	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Rheumatoid arthritis	14/488 (2.9%)	15	5/487 (1%)	6	4/330 (1.2%)	5	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Nervous system disorders
Headache	12/488 (2.5%)	12	14/487 (2.9%)	17	13/330 (3.9%)	16	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Reproductive system and breast disorders
Erectile dysfunction	0/488 (0%)	0	0/487 (0%)	0	2/79 (2.5%)	2	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Benign prostatic hyperplasia	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/47 (2.1%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Calculus prostatic	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	1/47 (2.1%)	1	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Ovarian cyst	0/488 (0%)	0	0/487 (0%)	0	0/330 (0%)	0	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	1/16 (6.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	8/488 (1.6%)	9	7/487 (1.4%)	7	7/330 (2.1%)	7	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Skin and subcutaneous tissue disorders
Rash	5/488 (1%)	6	3/487 (0.6%)	3	7/330 (2.1%)	7	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0
Vascular disorders
Hypertension	13/488 (2.7%)	13	9/487 (1.8%)	9	11/330 (3.3%)	11	0/306 (0%)	0	0/424 (0%)	0	0/267 (0%)	0	0/227 (0%)	0	0/33 (0%)	0	0/76 (0%)	0	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.