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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02265705
• Date of registration: 13/10/2014
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)
• Scientific 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
• Date of first enrolment: October 2014
• Target sample size: 290
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02265705
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Brazil, China

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have a diagnosis of adult-onset RA as defined by the ACR/European League Against
Rheumatism (EULAR) 2010 Criteria for the Classification of RA.

- Have moderately to severely active RA defined as the presence of at least 6/68 tender
joints and at least 6/66 swollen joints.

- Have a CRP (or hsCRP) measurement = 6 mg/liter (L) based on the most recent data (if
available).

- Have had regular use of MTX for at least the 12 weeks prior to study entry at a dose
that, in accordance with local clinical practice, is considered acceptable to
adequately assess clinical response. The dose of MTX must have been a stable,
unchanging oral dose of 7.5 to 25 mg/week (or the equivalent injectable dose) for at
least the 8 weeks prior to study entry. The dose of MTX is expected to remain stable
throughout the study and may be adjusted only for safety reasons.

Exclusion Criteria:

- Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or
equivalent) or have been receiving an unstable dosing regimen of corticosteroids
within 2 weeks of study entry or within 6 weeks of planned randomization.

- Have started treatment with NSAIDs within 2 weeks of study entry or within 6 weeks of
planned randomization or have been receiving an unstable dosing regimen of NSAIDs
within 2 weeks of study entry or within 6 weeks of planned randomization.

- Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and
sulfasalazine or combination of any 3 conventional disease modifying anti-rheumatic
drugs (cDMARDs).

- Are currently receiving or have received cDMARDs (for example, gold salts,
cyclosporine, azathioprine, or any other immunosuppressives) other than MTX,
hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 8
weeks prior to study entry.

- Have received leflunomide in the 12 weeks prior to study entry (or within 4 weeks
prior to study entry if the standard 11 days of cholestyramine is used to washout
leflunomide).

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

- Have ever received any biologic DMARD (such as tumor necrosis factor (TNF),
interleukin-1, interleukin-6 (IL-6), or T-cell- or B-cell-targeted therapies).

- Have received any parenteral corticosteroid administered by intramuscular or
intravenous injection within 2 weeks prior to study entry or within 6 weeks prior to
planned randomization or are anticipated to require parenteral injection of
corticosteroids during the study.

- Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic
acid within 2 weeks prior to study entry or within 6 weeks prior to planned
randomization.

- Have a diagnosis of any systemic inflammatory condition other than RA such as, but not
limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,
ulcerative colitis, psoriatic arthritis, active vasculitis or gout.

- Have an estimated glomerular filtration rate (eGFR) based on the most recent available
serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of <40
milliliters/minute/1.73 meters squared (m^2).

- Have a history of chronic liver disease with the most recent available aspartate
aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of
normal (ULN) or the most recent available total bilirubin 1.5 times the ULN.

- Have a current or recent (<30 days prior to study entry) clinically serious viral,
bacterial, fungal, or parasitic infection.

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

- Have had household contact with a person with active tuberculosis (TB) and did not
receive appropriate and documented prophylaxis for TB.

- Have evidence of active TB or have previously had evidence of active TB and did not
receive appropriate and documented treatment.

- Are pregnant or nursing at the time of study entry.

- Are females of childbearing potential who do not agree to use 2 forms of highly
effective birth control when engaging in intercourse while enrolled in the study and
for at least 28 days following the last dose of orally administered investigational
product.

- Are males who do not agree to use 2 forms of highly effective birth control while
engaging in sexual intercourse with female partners of childbearing potential while
enrolled in the study and for at least 28 days following the last dose of orally
administered investigational product.

- Have previously been randomized in this study or any other study investigating
baricitinib.

- Have received prior treatment with an oral janus kinase inhibitor.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Baricitinib

Drug: Placebo

Primary Outcome(s)

Percentage of Participants Achieving 20% Improvement in American College of Rheumatology Criteria (ACR20) [Time Frame: Week 12]

Secondary Outcome(s)

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]

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]

Median Duration of Morning Joint Stiffness 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]

Secondary ID(s)

I4V-CR-JAGS

14875

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02265705