A Study in Moderate to Severe Rheumatoid Arthritis Participants (RA-BUILD)

• ClinicalTrials.gov Identifier: NCT01721057
• Recruitment Status: Completed
• First Posted: November 2, 2012
• Results First Posted: June 12, 2017
• Last Update Posted: September 18, 2019
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: Baricitinib; Drug: cDMARD
• Enrollment: 684

Participant Flow

Recruitment Details
Pre-assignment Details	Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 16. Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg	Rescue	Placebo-Follow Up	Baricitinib 2 mg- Follow Up	Baricitinib 4 mg- Follow Up
Arm/Group Description	Placebo administered orally (PO) once daily (QD)through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.	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.	No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib 4 mg.
Period Title: Treatment Period
Started	228	229	227	0	0	0	0
Received at Least 1 Dose of Study Drug	228	229	227	0	0	0	0
Rescued	55	21	15	0	0	0	0
Completed	200 [1]	210 [1]	204 [1]	0	0	0	0
Not Completed	28	19	23	0	0	0	0
Reason Not Completed
Withdrawal by Subject	11	5	8	0	0	0	0
Adverse Event	7	10	12	0	0	0	0
Lack of Efficacy	7	3	0	0	0	0	0
Lost to Follow-up	1	0	0	0	0	0	0
Physician Decision	0	1	3	0	0	0	0
Death	2	0	0	0	0	0	0
[1] "Completers" include rescued participants.
Period Title: Rescue Period
Started	0 [1]	0 [1]	0 [1]	91 [2]	0	0	0
Completed	0	0	0	88	0	0	0
Not Completed	0	0	0	3	0	0	0
Reason Not Completed
Adverse Event	0	0	0	1	0	0	0
Lack of Efficacy	0	0	0	2	0	0	0
[1] Participants who were nonresponders based on tender/swollen joint count entered into rescue group.; [2] Participants who were determined to be nonresponders based on tender/swollen joint count.
Period Title: Follow Up
Started	0	0	0	0 [1]	17 [2]	19 [2]	22 [3]
Completed	0	0	0	0	17	19	22
Not Completed	0	0	0	0	0	0	0
[1] Rescued participants who entered post-treatment follow-up are included in Baricitinib 4 mg FollowUp; [2] Participants from treatment who entered the post-treatment follow-up period.; [3] Participants from treatment and rescue who entered the post-treatment follow-up period.

Baseline Characteristics

Arm/Group Title		Placebo	Baricitinib 2 mg	Baricitinib 4 mg	Total
Arm/Group Description		Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 2 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.	Total of all reporting groups
Overall Number of Baseline Participants		228	229	227	684
Baseline Analysis Population Description		Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		51.4 (12.5)	52.2 (12.3)	51.8 (12.1)	51.8 (12.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
	Female	189 82.9%	184 80.3%	187 82.4%	560 81.9%
	Male	39 17.1%	45 19.7%	40 17.6%	124 18.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
	Hispanic or Latino	12 5.3%	15 6.6%	17 7.5%	44 6.4%
	Not Hispanic or Latino	45 19.7%	43 18.8%	43 18.9%	131 19.2%
	Unknown or Not Reported	171 75.0%	171 74.7%	167 73.6%	509 74.4%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
	American Indian or Alaska Native	3 1.3%	2 0.9%	9 4.0%	14 2.0%
	Asian	60 26.3%	61 26.6%	59 26.0%	180 26.3%
	Native Hawaiian or Other Pacific Islander	1 0.4%	0 0.0%	0 0.0%	1 0.1%
	Black or African American	10 4.4%	9 3.9%	9 4.0%	28 4.1%
	White	153 67.1%	156 68.1%	148 65.2%	457 66.8%
	More than one race	1 0.4%	1 0.4%	1 0.4%	3 0.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	1 0.4%	1 0.1%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
Argentina	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		25	21	18	64
Australia	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		8	1	6	15
Belgium	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		1	4	6	11
Canada	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		10	10	8	28
Croatia	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		0	2	2	4
Czech Republic	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		7	5	3	15
Germany	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		4	2	3	9
Hungary	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		7	8	5	20
India	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		19	19	20	58
Italy	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		3	3	4	10
Japan	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		8	6	7	21
Korea, Republic of	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		6	7	4	17
Mexico	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		3	8	11	22
Poland	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		18	13	20	51
Portugal	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		2	2	1	5
Romania	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		1	3	2	6
Russian Federation	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		4	10	6	20
Slovakia	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		3	5	3	11
Spain	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		14	10	10	34
Taiwan	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		26	28	28	82
United Kingdom	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		1	4	0	5
United States	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		58	58	60	176
Duration of Rheumatoid Arthritis [1]; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	228 participants	225 participants	225 participants	678 participants
		7.2 (7.5)	7.6 (7.6)	7.7 (7.9)	7.5 (7.6)
		[1] Measure Analysis Population Description: Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug and had evaluable baseline data.
Tender Joint Count of 68 Evaluable Joints; Mean (Standard Deviation); Unit of measure: Number of Joints
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		24.3 (15.0)	23.5 (14.1)	24.3 (14.0)	24.0 (14.3)
Swollen Joint Count of 66 Evaluable Joints; Mean (Standard Deviation); Unit of measure: Number of Joints
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		13.1 (7.2)	13.6 (8.7)	13.5 (6.9)	13.4 (7.6)
High Sensitivity C-Reactive Protein (hsCRP); Mean (Standard Deviation); Unit of measure: Milligram per Liter (mg/L)
	Number Analyzed	228 participants	229 participants	227 participants	684 participants
		17.7 (20.4)	18.2 (21.5)	14.2 (14.5)	16.7 (19.1)

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 discontinue study or drug or are rescued before analysis timepoint are 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 the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally (PO) once daily (QD)through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Measure Type: Number; Unit of Measure: percentage of participants
	39.5	65.9	61.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Baricitinib 4 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	[Not Specified]

2. 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: 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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Mean (Standard Deviation); Unit of Measure: units on a scale
	-0.30 (0.45)	-0.52 (0.59)	-0.52 (0.60)

3. 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: 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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.05 (1.23)	-1.83 (1.22)	-1.91 (1.21)

4. Secondary Outcome

Title	Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤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), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Time Frame	Week 12

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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg PO QD through week 24. Participants will continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Measure Type: Number; Unit of Measure: percentage of participants
	0.9	9.2	8.8

5. Secondary Outcome

Title	Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
Description	Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS 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 is calculated. A decrease in duration of MJS 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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	221	223	222
Median (95% Confidence Interval); Unit of Measure: minutes
	60.0; (50.7 to 76.7)	44.4; (30.0 to 60.0)	34.6; (23.7 to 51.4)

6. 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 MJS by selecting a number from 0 to 10 that best described their overall level of MJS 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 is calculated. A decrease in severity rating 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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	221	223	222
Mean (Standard Deviation); Unit of Measure: units on a scale
	4.2 (2.3)	3.5 (2.5)	3.4 (2.2)

7. 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 level of worst tiredness during the past 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating 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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	221	223	222
Mean (Standard Deviation); Unit of Measure: units on a scale
	4.5 (2.2)	4.0 (2.5)	4.0 (2.3)

8. Secondary Outcome

Title	Mean Worst Joint Pain Numeric Rating Scale (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 is calculated. A decrease in joint pain severity rating 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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	221	223	222
Mean (Standard Deviation); Unit of Measure: units on a scale
	4.7 (2.2)	3.9 (2.5)	3.8 (2.2)

9. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Description	ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician 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 discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Time Frame	Week 12, Week 24

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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Measure Type: Number; Unit of Measure: percentage of participants
Week 12	12.7	33.6	33.5
Week 24	21.5	41.5	44.1

10. Secondary Outcome

Title	Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Description	ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician 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 discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Time Frame	Week 12, Week 24

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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Measure Type: Number; Unit of Measure: percentage of participants
Week 12	3.1	17.9	18.1
Week 24	7.9	25.3	24.2

11. Secondary Outcome

Title	Change From Baseline in Measures of 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 24

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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. . Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	218	224	219
Mean (Standard Deviation); Unit of Measure: units on a scale
	-14.29 (16.04)	-20.99 (14.48)	-23.18 (13.47)

12. Secondary Outcome

Title	Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
Description	The 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 visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
Time Frame	Baseline, Week 24

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 mLOCF.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	218	224	219
Mean (Standard Deviation); Unit of Measure: units on a scale
	-14.55 (16.37)	-21.87 (14.99)	-23.78 (13.94)

13. Secondary Outcome

Title	Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Description	DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. 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: 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 mLOCF.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	220	226	221
Mean (Standard Deviation); Unit of Measure: units on a scale
	-1.16 (1.27)	-1.89 (1.23)	-1.97 (1.16)

14. 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

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 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	228	229	227
Measure Type: Number; Unit of Measure: percentage of participants
	0.4	7.0	6.6

15. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) 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; Baseline Week 24

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 mLOCF.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	216	227	216
Mean (Standard Deviation); Unit of Measure: units on a scale
Week 12	7.6 (10.3)	8.7 (11.1)	8.8 (10.6)
Week 24	7.8 (11.0)	9.2 (10.7)	9.7 (10.8)

16. 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; Baseline, Week 24

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 mLOCF.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally (PO) once daily (QD) through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	218	229	219
Mean (Standard Deviation); Unit of Measure: units on a scale
Week 12, MCS	3.3 (10.6)	3.6 (10.5)	3.3 (11.0)
Week 24, MCS	2.7 (11.5)	3.0 (10.4)	3.3 (11.3)
Week 12, PCS	4.1 (7.3)	7.7 (8.5)	7.0 (8.3)
Week 24, PCS	4.9 (8.0)	8.5 (9.0)	8.6 (9.0)

17. 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; Baseline Week 24

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 mLOCF.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	216	227	216
Mean (Standard Deviation); Unit of Measure: units on a scale
Index Score (US Algorithm) Week 12	0.054 (0.155)	0.117 (0.151)	0.109 (0.165)
Index Score (US Algorithm) Week 24	0.051 (0.149)	0.113 (0.172)	0.129 (0.173)
Index Score (UK Algorithm) Week 12	0.074 (0.230)	0.167 (0.221)	0.159 (0.237)
Index Score (UK Algorithm) Week 24	0.075 (0.218)	0.162 (0.254)	0.185 (0.250)

18. 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; Baseline Week 24

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 mLOCF.

Arm/Group Title	Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	216	227	216
Mean (Standard Deviation); Unit of Measure: mm
Self-Perceived Health, Week 12	5.7 (23.8)	13.4 (21.8)	11.5 (25.2)
Self-Perceived Health, Week 24	8.4 (25.1)	13.1 (25.8)	10.4 (28.8)

19. 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; Baseline, Week 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Placebo	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:		Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.	Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.	Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed		228	229	227
Mean (Standard Deviation); Unit of Measure: percentage of impairment
Absenteeism Week 12	Number Analyzed	73 participants	72 participants	69 participants
		2.6 (23.5)	-6.3 (26.5)	2.5 (24.7)
Absenteeism Week 24	Number Analyzed	44 participants	62 participants	56 participants
		-2.1 (13.9)	-3.8 (28.2)	4.0 (27.2)
Presenteeism Week 12	Number Analyzed	71 participants	69 participants	66 participants
		-8 (26)	-17 (25)	-15 (27)
Presenteeism Week 24	Number Analyzed	44 participants	61 participants	53 participants
		-17 (26)	-20 (23)	-17 (21)
Work Productivity Loss Week 12	Number Analyzed	71 participants	69 participants	66 participants
		-4.2 (27.7)	-17.6 (30.4)	-9.9 (23.7)
Work Producivity Loss Week 24	Number Analyzed	44 participants	61 participants	53 participants
		-15.9 (26.1)	-19.6 (25.0)	-14.3 (23.0)
Activity Impairment Week 12	Number Analyzed	206 participants	222 participants	213 participants
		-13 (25)	-19 (27)	-19 (25)
Activity Impairment Week 24	Number Analyzed	141 participants	187 participants	187 participants
		-18 (27)	-23 (28)	-21 (27)

20. Secondary Outcome

Title	Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
Description	[Not Specified]
Time Frame	Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug with evaluable PK data.

Arm/Group Title	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	246	245
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanogram per milliliter (ng/mL)
	70.2; (26.2%)	138; (25.7%)

21. Secondary Outcome

Title	Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104
Description	[Not Specified]
Time Frame	Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least 1 dose of study drug with evaluable PK data.

Arm/Group Title	Baricitinib 2 mg	Baricitinib 4 mg
Arm/Group Description:	Baricitinib 2 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.	Baricitinib 4 mg PO QD through week 24. Participants will continue to take background cDMARD therapy throughout study.
Overall Number of Participants Analyzed	246	245
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: nanograms per mL per hour (ng/mL*h)
	637; (44.5%)	1210; (47%)

Adverse Events

Time Frame

[Not Specified]

Adverse Event Reporting Description

All randomized participants who received at least 1 dose of study drug.

Arm/Group Title

Placebo-Treatment Period

Baricitinib 2 Mg-Treatment Period

Baricitinib 4 Mg-Treatment Period

Rescue

Placebo-Follow Up

Baricitinib 2 mg- Follow Up

Baricitinib 4 mg- Follow Up

Arm/Group Description

Placebo administered orally once daily through Week 24. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.

Baricitinib 2 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 24. Participants continued to take background cDMARD therapy throughout study.

Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.

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.

No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib 4 mg.

All-Cause Mortality

Placebo-Treatment Period

Baricitinib 2 Mg-Treatment Period

Baricitinib 4 Mg-Treatment Period

Rescue

Placebo-Follow Up

Baricitinib 2 mg- Follow Up

Baricitinib 4 mg- Follow Up

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

--/--

--/--

--/--

--/--

--/--

Serious Adverse Events

Placebo-Treatment Period

Baricitinib 2 Mg-Treatment Period

Baricitinib 4 Mg-Treatment Period

Rescue

Placebo-Follow Up

Baricitinib 2 mg- Follow Up

Baricitinib 4 mg- 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

Total

13/228 (5.70%)

6/229 (2.62%)

12/227 (5.29%)

1/91 (1.10%)

1/17 (5.88%)

0/19 (0.00%)

1/22 (4.55%)

Blood and lymphatic system disorders

Anaemia † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Cardiac disorders

Angina pectoris † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Atrial fibrillation † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Myocardial infarction † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Ventricular tachycardia † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Gastrointestinal disorders

Diverticulum intestinal † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Dyspepsia † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Gastrointestinal haemorrhage † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Hepatobiliary disorders

Cholecystitis acute † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Infections and infestations

Appendicitis † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Bacterial infection † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Bronchitis † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Cellulitis † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

1/91 (1.10%)

1

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Disseminated tuberculosis † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Gastroenteritis † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Lower respiratory tract infection † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Pelvic abscess † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Pneumonia † 1

2/228 (0.88%)

2

1/229 (0.44%)

1

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Sepsis † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Urinary tract infection † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

1/91 (1.10%)

1

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Viral infection † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Wound infection staphylococcal † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Injury, poisoning and procedural complications

Animal bite † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Fall † 1

2/228 (0.88%)

2

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Patella fracture † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Tibia fracture † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Upper limb fracture † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Musculoskeletal and connective tissue disorders

Back pain † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Muscular weakness † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Myalgia † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Myositis † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Polymyositis † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Rheumatoid arthritis † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Spinal pain † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Synovial cyst † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Nervous system disorders

Migraine † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Subarachnoid haemorrhage † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Psychiatric disorders

Depression † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Post-traumatic stress disorder † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Suicidal ideation † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Renal and urinary disorders

Renal failure † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Acute respiratory failure † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Allergic bronchitis † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Interstitial lung disease † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Pleural effusion † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Pulmonary embolism † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0

0/19 (0.00%)

0

1/22 (4.55%)

1

Skin and subcutaneous tissue disorders

Psoriasis † 1

0/228 (0.00%)

0

1/229 (0.44%)

1

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Rash pruritic † 1

0/228 (0.00%)

0

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Subcutaneous emphysema † 1

1/228 (0.44%)

1

0/229 (0.00%)

0

0/227 (0.00%)

0

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

2%

Placebo-Treatment Period

Baricitinib 2 Mg-Treatment Period

Baricitinib 4 Mg-Treatment Period

Rescue

Placebo-Follow Up

Baricitinib 2 mg- Follow Up

Baricitinib 4 mg- 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

Total

105/228 (46.05%)

108/229 (47.16%)

127/227 (55.95%)

21/91 (23.08%)

2/17 (11.76%)

0/19 (0.00%)

4/22 (18.18%)

Blood and lymphatic system disorders

Anaemia † 1

6/228 (2.63%)

6

6/229 (2.62%)

6

4/227 (1.76%)

4

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Cardiac disorders

Sinus bradycardia † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

0/17 (0.00%)

0

0/19 (0.00%)

0

1/22 (4.55%)

1

Gastrointestinal disorders

Abdominal pain † 1

0/228 (0.00%)

0

5/229 (2.18%)

5

3/227 (1.32%)

3

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Abdominal pain upper † 1

1/228 (0.44%)

1

5/229 (2.18%)

5

4/227 (1.76%)

4

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Constipation † 1

3/228 (1.32%)

4

7/229 (3.06%)

7

5/227 (2.20%)

5

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Diarrhoea † 1

10/228 (4.39%)

11

10/229 (4.37%)

11

4/227 (1.76%)

5

2/91 (2.20%)

2

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Dyspepsia † 1

2/228 (0.88%)

2

1/229 (0.44%)

1

5/227 (2.20%)

5

2/91 (2.20%)

2

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Gastritis † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

0/17 (0.00%)

0

0/19 (0.00%)

0

1/22 (4.55%)

1

Gastrooesophageal reflux disease † 1

5/228 (2.19%)

5

2/229 (0.87%)

2

1/227 (0.44%)

1

2/91 (2.20%)

2

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Lip disorder † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

0/17 (0.00%)

0

0/19 (0.00%)

0

1/22 (4.55%)

1

Mouth ulceration † 1

0/228 (0.00%)

0

5/229 (2.18%)

6

3/227 (1.32%)

3

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Nausea † 1

8/228 (3.51%)

9

7/229 (3.06%)

7

5/227 (2.20%)

5

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Vomiting † 1

4/228 (1.75%)

5

7/229 (3.06%)

7

4/227 (1.76%)

4

2/91 (2.20%)

2

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

General disorders

Fatigue † 1

5/228 (2.19%)

5

2/229 (0.87%)

3

5/227 (2.20%)

5

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Oedema peripheral † 1

6/228 (2.63%)

6

3/229 (1.31%)

3

3/227 (1.32%)

3

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Pyrexia † 1

2/228 (0.88%)

2

1/229 (0.44%)

1

5/227 (2.20%)

7

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Infections and infestations

Bronchitis † 1

11/228 (4.82%)

12

6/229 (2.62%)

7

7/227 (3.08%)

8

2/91 (2.20%)

2

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Gastroenteritis † 1

1/228 (0.44%)

1

4/229 (1.75%)

4

9/227 (3.96%)

9

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Nasopharyngitis † 1

18/228 (7.89%)

19

10/229 (4.37%)

10

18/227 (7.93%)

22

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Pharyngitis † 1

3/228 (1.32%)

3

6/229 (2.62%)

6

8/227 (3.52%)

8

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Rash pustular † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Sinusitis † 1

6/228 (2.63%)

6

3/229 (1.31%)

3

4/227 (1.76%)

4

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Upper respiratory tract infection † 1

18/228 (7.89%)

19

14/229 (6.11%)

16

24/227 (10.57%)

26

2/91 (2.20%)

2

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Urinary tract infection † 1

4/228 (1.75%)

5

12/229 (5.24%)

13

9/227 (3.96%)

9

3/91 (3.30%)

3

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Investigations

Alanine aminotransferase increased † 1

2/228 (0.88%)

3

5/229 (2.18%)

6

5/227 (2.20%)

6

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Aspartate aminotransferase increased † 1

1/228 (0.44%)

2

3/229 (1.31%)

3

6/227 (2.64%)

7

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Blood creatine phosphokinase increased † 1

0/228 (0.00%)

0

8/229 (3.49%)

8

15/227 (6.61%)

17

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Metabolism and nutrition disorders

Hypercholesterolaemia † 1

2/228 (0.88%)

2

5/229 (2.18%)

5

9/227 (3.96%)

9

4/91 (4.40%)

4

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Hyperlipidaemia † 1

2/228 (0.88%)

2

2/229 (0.87%)

2

6/227 (2.64%)

6

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Musculoskeletal and connective tissue disorders

Arthralgia † 1

3/228 (1.32%)

3

6/229 (2.62%)

8

6/227 (2.64%)

6

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Back pain † 1

10/228 (4.39%)

10

9/229 (3.93%)

9

5/227 (2.20%)

5

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Nervous system disorders

Dizziness † 1

4/228 (1.75%)

4

3/229 (1.31%)

3

7/227 (3.08%)

9

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Headache † 1

8/228 (3.51%)

10

15/229 (6.55%)

17

9/227 (3.96%)

10

3/91 (3.30%)

3

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Psychiatric disorders

Depression † 1

7/228 (3.07%)

7

0/229 (0.00%)

0

1/227 (0.44%)

1

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Reproductive system and breast disorders

Erectile dysfunction † 1

0/39 (0.00%)

0

0/45 (0.00%)

0

1/40 (2.50%)

1

0/13 (0.00%)

0

0/6 (0.00%)

0

0/4 (0.00%)

0

0/3 (0.00%)

0

Vulvovaginal pruritus † 1

0/189 (0.00%)

0

0/184 (0.00%)

0

0/187 (0.00%)

0

0/78 (0.00%)

0

1/11 (9.09%)

1

0/15 (0.00%)

0

0/19 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

Cough † 1

3/228 (1.32%)

4

9/229 (3.93%)

11

9/227 (3.96%)

10

0/91 (0.00%)

0/17 (0.00%)

0

0/19 (0.00%)

0

1/22 (4.55%)

1

Dyspnoea † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

0/17 (0.00%)

0

0/19 (0.00%)

0

1/22 (4.55%)

1

Oropharyngeal pain † 1

2/228 (0.88%)

2

4/229 (1.75%)

4

9/227 (3.96%)

9

3/91 (3.30%)

3

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Skin and subcutaneous tissue disorders

Acne † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

2/91 (2.20%)

2

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Alopecia † 1

4/228 (1.75%)

4

1/229 (0.44%)

1

6/227 (2.64%)

6

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

Dermatitis bullous † 1

0/228 (0.00%)

0/229 (0.00%)

0/227 (0.00%)

0/91 (0.00%)

1/17 (5.88%)

1

0/19 (0.00%)

0

0/22 (0.00%)

0

Vascular disorders

Hypertension † 1

2/228 (0.88%)

2

10/229 (4.37%)

10

6/227 (2.64%)

6

0/91 (0.00%)

0/17 (0.00%)

0/19 (0.00%)

0/22 (0.00%)

† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Chief Medical Officer
• Organization: Eli Lilly and Company
• Phone: 800-545-5979

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.

van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.

Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.

Thudium CS, Bay-Jensen AC, Cahya S, Dow ER, Karsdal MA, Koch AE, Zhang W, Benschop RJ. The Janus kinase 1/2 inhibitor baricitinib reduces biomarkers of joint destruction in moderate to severe rheumatoid arthritis. Arthritis Res Ther. 2020 Oct 12;22(1):235. doi: 10.1186/s13075-020-02340-7.

Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum In: Arthritis Res Ther. 2020 Jul 2;22(1):166.

Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0. Erratum In: Trials. 2019 Jun 4;20(1):322.

Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.

Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649.

Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.

Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.

Emery P, Blanco R, Maldonado Cocco J, Chen YC, Gaich CL, DeLozier AM, de Bono S, Liu J, Rooney T, Chang CH, Dougados M. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis. RMD Open. 2017 Mar 21;3(1):e000410. doi: 10.1136/rmdopen-2016-000410. eCollection 2017.

Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, Beattie S, Witt S, de la Torre I, Gaich C, Rooney T, Schlichting D, de Bono S, Emery P. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. doi: 10.1136/annrheumdis-2016-210094. Epub 2016 Sep 29. Erratum In: Ann Rheum Dis. 2017 Sep;76(9):1634.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01721057
• Other Study ID Numbers: 14059; I4V-MC-JADX ( Other Identifier: Eli Lilly and Company )
• First Submitted: November 1, 2012
• First Posted: November 2, 2012
• Results First Submitted: May 1, 2017
• Results First Posted: June 12, 2017
• Last Update Posted: September 18, 2019