A Study in Participants With Moderate to Severe Rheumatoid Arthritis
(RA-BEGIN Trial)

Recruiting in Palo Alto (17 mi)

+153 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

Eligibility Criteria

Inclusion Criteria

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

Have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test

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

See 2 more

Treatment Details

Interventions

Baricitinib (Janus Kinase (JAK) Inhibitor)
Methotrexate (Disease-Modifying Antirheumatic Drug (DMARD))

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Baricitinib + MTXExperimental Treatment3 Interventions

Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.

Group II: BaricitinibExperimental Treatment3 Interventions

Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.

Group III: MTXActive Control3 Interventions

MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.

Baricitinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Olumiant for:

Rheumatoid arthritis
Severe alopecia areata
COVID-19

🇪🇺 Approved in European Union as Olumiant for:

Rheumatoid arthritis
Severe alopecia areata
COVID-19

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:

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.Lakewood, CA