Rheumatoid ArthritisPhase 3NCT02265705

A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)

A Phase 3 study testing Baricitinib in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 30 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as baricitinib in participants with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Baricitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 30 sitesin 3 countries
Study dates: Oct 2014to May 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have a diagnosis of adult-onset RA as defined by the ACR/European League Against Rheumatism (EULAR) 2010 Criteria for the Classification of RA.
Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints.
Have a CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if available).
Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.

Who cannot join

Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization.
Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs).
Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry.
Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide).
Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry.

Show all 21Show fewer

Have ever received any biologic DMARD (such as tumor necrosis factor (TNF), interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies).
Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
Have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout.
Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of <40 milliliters/minute/1.73 meters squared (m^2).
Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN) or the most recent available total bilirubin 1.5 times the ULN.
Have a current or recent (<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection.
Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB.
Have evidence of active TB or have previously had evidence of active TB and did not receive appropriate and documented treatment.
Are pregnant or nursing at the time of study entry.
Are females of childbearing potential who do not agree to use 2 forms of highly effective birth control when engaging in intercourse while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product.
Are males who do not agree to use 2 forms of highly effective birth control while engaging in sexual intercourse with female partners of childbearing potential while enrolled in the study and for at least 28 days following the last dose of orally administered investigational product.
Have previously been randomized in this study or any other study investigating baricitinib.
Have received prior treatment with an oral janus kinase inhibitor.

Trial locations and contacts

30 sites in 3 countries.

Country

City, postcode or hospital

30 sites in 3 countries

China22 sites

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, 100029
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Beijing, 100044
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Bengbu, 233004
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Changsha, 410008
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Changsha, 410011
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Chengdu, 610041
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Guangzhou, 510080
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Hefei, 230001
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Hefei, 230022
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Jinan, 250012
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Kunming, 650032
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Nanjing, 210029
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Ningbo, 315010
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Pingxiang, 337055
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Shanghai, 200001
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Shanghai, 200032
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Shanghai, 200052
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Shantou, 515041
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Tianjin, 300052
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Wuhan, 430030
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Yancheng, 224005
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Zhuzhou, 412007

Other trials in China

Argentina6 sites

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.
Ciudad Autonoma de Buenos Aire, C1015ABO
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Ciudad Autonoma de Buenos Aire, C1431FWO
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Ciudad Autonoma de Buenos Aire, C1440AAD
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Rosario, S2000CFJ
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San Juan, J5402DIL
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San Miguel de Tucumán, T4000AXL

Other trials in Argentina

Brazil2 sites

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São Paulo, 01244-030
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São Paulo, 04266-010

Other trials in Brazil

About this study

Official title: A Randomized, Double-Blind, Placebo-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

Conditions: Rheumatoid Arthritis
Being tested: Baricitinib, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BaricitinibDrug
Also called LY3009104, INCB 028050
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT02265705
Study group	Role	What they receive
Baricitinib	Experimental	4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks. Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline. Receives: Drug: Baricitinib
Placebo	Placebo comparator	Placebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52. Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.
Measured: Week 12

Secondary outcomes (7)

Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count-28 (TJC28), swollen joint count-28 (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using VAS (patient's global VAS). DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity, and remission was DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Measured: Baseline, Week 12
Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Measured: Week 12
Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12
Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into paper diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Measured: Week 12
Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12
Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in paper diaries. The average value across the 7 days preceding each visit was calculated.
Measured: Week 12
Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12
Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in paper diaries. The average value across the 7 days preceding each visit is calculated.
Measured: Week 12
Mean Worst Pain NRS in the 7 Days Prior to Week 12
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily paper diaries. The average value across the 7 days preceding each visit was calculated.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014May 2017

First posted16 Oct 2014 (estimated)
Study startOct 2014
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02265705
Sponsor's protocol ID: 14875
Other IDs: I4V-CR-JAGS
Status last verified: Aug 2019
First submitted: 13 Oct 2014
Last updated: 11 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

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.
PubMed 34706874
Yang Y, Xu J, Xu J, Li X, Hu J, Li X, Zhang X, He D, Bao C, Li Z, Wang G, Zerbini CAF, Spindler AJ, Kannowski CL, Wu H, Ji F, Zhan L, Liu M, Li Z. Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study. Ther Adv Musculoskelet Dis. 2021 Apr 20;13:1759720X211006964. doi: 10.1177/1759720X211006964. eCollection 2021.
PubMed 33959198
Li ZG, Hu JK, Li XP, Yang Y, Li XF, Xu JH, Zhang X, Xu J, Bao CD, He DY, Li ZJ, Wang GC, Zuo XX, Liu Y, Xiao ZY, Chen JW, Xin XF, Li JY, Jiang LD, Liu MR, Ji F, Li CG. Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE. Adv Ther. 2021 Jan;38(1):772-781. doi: 10.1007/s12325-020-01572-y. Epub 2020 Nov 25.
PubMed 33237533
Yang Y, Li XF, Zhang X, Bao CD, Hu JK, Xu JH, Li XP, Xu J, He DY, Li ZJ, Wang GC, Wu HJ, Ji F, Zhan LJ, Zerbini CAF, Li ZG. Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE. Rheumatol Ther. 2020 Dec;7(4):851-866. doi: 10.1007/s40744-020-00231-6. Epub 2020 Sep 2.
PubMed 32876903

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-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
ClinicalTrials.gov ID: NCT02265705
Acronym / sponsor ID: 14875
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Posted 13 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Baricitinib	Experimental	Drug: Baricitinib4 milligrams (mg) baricitinib administered orally once a day for 52 weeks. Participants with renal impairment will receive 2 mg baricitinib orally once a day for 52 weeks. Participants will continue to take background methotrexate (MTX) therapy throughout study. Other background therapies, including non-steroidal anti-inflammatory drugs (NSAIDs) and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered orally once a day through week 24. At week 24, participants will be given 4 mg or 2 mg (participants with renal impairment) baricitinib orally once a day through Week 52. Participants will continue to take background MTX therapy throughout study. Other background therapies, including NSAIDs and low dose oral corticosteroids, are permitted during the study for participants who are on stable doses of these treatments at baseline.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Have a diagnosis of adult-onset RA as defined by the ACR/European League Against Rheumatism (EULAR) 2010 Criteria for the Classification of RA.
Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints.
Have a CRP (or hsCRP) measurement ≥ 6 mg/liter (L) based on the most recent data (if available).
Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose that, in accordance with local clinical practice, is considered acceptable to adequately assess clinical response. The dose of MTX must have been a stable, unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable throughout the study and may be adjusted only for safety reasons.

Key exclusion criteria (21 listed)

Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization.
Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs).
Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry.
Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BaricitinibAlso: LY3009104, INCB 028050Administered orally	Drug	Baricitinib
PlaceboAdministered orally	Drug	Placebo

Primary outcome

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)
Time frame: Week 12
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). An ACR20 Responder is a participant who had ≥20% improvement from baseline in both 68 tender and 66 swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: Patient's and Physician's Global Assessment of Disease Activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessment of participant's physical function), pain due to RA, and hsCRP. Participants who discontinue before analysis time point are treated as non-responders. Percentage of participants achieving ACR20 response = (number of ACR20 responders) / (number of participants analyzed) * 100.

7 secondary outcomes

Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Disease Activity Score Modified to Include the 28 Diarthroidal Joint Count (DAS28)-High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 12
Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3
Time frame: Week 12
Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12
Time frame: Week 12
Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12
Time frame: Week 12
Mean Worst Tiredness Numeric Rating Scale (NRS) in the 7 Days Prior to Week 12
Time frame: Week 12
Mean Worst Pain NRS in the 7 Days Prior to Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 13 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Treatment Period Week 0-24	145	133
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24	145	136
Rescue Treatment Period Week 16-52	0	0
Placebo to Baricitinib Treatment Period Week 24 - 52	0	0
4 mg Baricitinib Treatment Period Week 24-52	0	0
Placebo Follow-up Period	0	0
4 mg Baricitinib Follow-up Period	0	0

Primary outcome: Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20)

Time frame: Week 12. Number. Unit: percentage of participants

Measure	Placebo n = 145	Baricitinib n = 145
Value	28.3	58.6

Placebo vs Baricitinib: Odds Ratio (OR): 4.1 (95% CI 2.5 to 6.9), p = 0.001, Regression, Logistic

Population analysed: All randomized participants who received at least one dose of the study drug.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Start of treatment to end of study (Up To 52 Weeks). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Treatment Period Week 0-24	4 of 145 (2.8%)	72 of 145 (49.7%)	0 of 145
4 Milligrams (mg) Baricitinib Treatment Period Week 0-24	4 of 145 (2.8%)	94 of 145 (64.8%)	0 of 145
Rescue Treatment Period Week 16-52	3 of 77 (3.9%)	38 of 77 (49.4%)	1 of 77
Placebo to Baricitinib Treatment Period Week 24 - 52	7 of 74 (9.5%)	31 of 74 (41.9%)	0 of 74
4 mg Baricitinib Treatment Period Week 24-52	3 of 120 (2.5%)	41 of 120 (34.2%)	0 of 120
Placebo Follow-up Period	0 of 2 (0%)	0 of 2 (0%)	0 of 2
4 mg Baricitinib Follow-up Period	1 of 58 (1.7%)	3 of 58 (5.2%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34706874Taylor 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.
Derived from this study: PubMed 33959198Yang Y, Xu J, Xu J, Li X, Hu J, Li X, Zhang X, He D, Bao C, Li Z, Wang G, Zerbini CAF, Spindler AJ, Kannowski CL, Wu H, Ji F, Zhan L, Liu M, Li Z. Patient-reported outcomes from a randomized, double-blind, placebo controlled, phase III study of baricitinib versus placebo in patients with moderately to severely active rheumatoid arthritis and an inadequate response to methotrexate therapy: results from the RA-BALANCE study. Ther Adv Musculoskelet Dis. 2021 Apr 20;13:1759720X211006964. doi: 10.1177/1759720X211006964. eCollection 2021.
Derived from this study: PubMed 33237533Li ZG, Hu JK, Li XP, Yang Y, Li XF, Xu JH, Zhang X, Xu J, Bao CD, He DY, Li ZJ, Wang GC, Zuo XX, Liu Y, Xiao ZY, Chen JW, Xin XF, Li JY, Jiang LD, Liu MR, Ji F, Li CG. Rapid Onset of Efficacy of Baricitinib in Chinese Patients with Moderate to Severe Rheumatoid Arthritis: Results from Study RA-BALANCE. Adv Ther. 2021 Jan;38(1):772-781. doi: 10.1007/s12325-020-01572-y. Epub 2020 Nov 25.
Derived from this study: PubMed 32876903Yang Y, Li XF, Zhang X, Bao CD, Hu JK, Xu JH, Li XP, Xu J, He DY, Li ZJ, Wang GC, Wu HJ, Ji F, Zhan LJ, Zerbini CAF, Li ZG. Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE. Rheumatol Ther. 2020 Dec;7(4):851-866. doi: 10.1007/s40744-020-00231-6. Epub 2020 Sep 2.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

30 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baricitinib in people with Rheumatoid Arthritis, run by Eli Lilly and Company at 30 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China, Argentina, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02265705, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.