NCT02265705|CompletedPhase 3Results

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

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

Eli Lilly and Company ClinicalTrials.gov

Compare

2 other identifiers

14875I4V-CR-JAGS

Study Type

interventional

Target

290

Locations

3 countries

Sites

Timeline

RegisteredOct 2014

StartedOct 2014

CompletionMay 2017

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

290

participants targeted

Target at P50-P75 for phase_3 rheumatoid-arthritis

Timeline

Completed

Started Oct 2014

Geographic Reach

3 countries

30 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

October 1, 2014

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2014

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed

Last Updated

September 11, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

October 13, 2014

Results QC Date

May 15, 2018

Last Update Submit

August 28, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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.
Week 12

Secondary Outcomes (7)

Change From Baseline to Week 12 in the Health Assessment Questionnaire Disability Index (HAQ-DI) Score
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)
Baseline, Week 12
Proportion of Participants Achieving a Simplified Disease Activity Index (SDAI) Score < or Equal to 3.3
Week 12
Median Duration of Morning Joint Stiffness in the 7 Days Prior to Week 12
Week 12
Mean Severity of Morning Joint Stiffness in the 7 Days Prior to Week 12
Week 12
+2 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

BaricitinibDRUG

Administered orally

Also known as: LY3009104, INCB 028050

Baricitinib

PlaceboDRUG

Administered orally

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Are currently receiving corticosteroids at doses \>10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization.
Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization.
Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic drugs (cDMARDs).
Are currently receiving or have received cDMARDs (for example, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8 weeks prior to study entry.
Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks prior to study entry if the standard 11 days of cholestyramine is used to washout leflunomide).
Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry.
Have ever received any biologic DMARD (such as tumor necrosis factor (TNF), interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies).
Have received any parenteral corticosteroid administered by intramuscular or intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study.
Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization.
Have a diagnosis of any systemic inflammatory condition other than RA such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout.
Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \<40 milliliters/minute/1.73 meters squared (m\^2).
Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal (ULN) or the most recent available total bilirubin 1.5 times the ULN.
Have a current or recent (\<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection.
Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
Have had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB.
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (30)

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, Argentina

Location

Ciudad Autonoma de Buenos Aire, C1431FWO, Argentina

Location

Ciudad Autonoma de Buenos Aire, C1440AAD, Argentina

Location

Rosario, S2000CFJ, Argentina

Location

San Juan, J5402DIL, Argentina

Location

San Miguel de Tucumán, T4000AXL, Argentina

Location

São Paulo, 01244-030, Brazil

Location

São Paulo, 04266-010, Brazil

Location

Beijing, 100029, China

Location

Beijing, 100044, China

Location

Bengbu, 233004, China

Location

Changsha, 410008, China

Location

Changsha, 410011, China

Location

Chengdu, 610041, China

Location

Guangzhou, 510080, China

Location

Hefei, 230001, China

Location

Hefei, 230022, China

Location

Jinan, 250012, China

Location

Kunming, 650032, China

Location

Nanjing, 210029, China

Location

Ningbo, 315010, China

Location

Pingxiang, 337055, China

Location

Shanghai, 200001, China

Location

Shanghai, 200032, China

Location

Shanghai, 200052, China

Location

Shantou, 515041, China

Location

Tianjin, 300052, China

Location

Wuhan, 430030, China

Location

Yancheng, 224005, China

Location

Zhuzhou, 412007, China

Location

Related Publications (4)

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.
PMID: 34706874DERIVED
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.
PMID: 33959198DERIVED
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.
PMID: 33237533DERIVED
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.
PMID: 32876903DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 16, 2014

Study Start

October 1, 2014

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 11, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing: Will share
Shared Documents: STUDY PROTOCOL, SAP, CSR
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CN(22)BR(2)AR(6)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (2)

Baricitinib

Placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (30)

Related Publications (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations