A Study in Participants With Moderate to Severe Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Baricitinib — DRUG
  Administered orally
• Methotrexate — DRUG
  Administered orally
• Baricitinib Placebo — DRUG
  Baricitinib placebo administered orally once daily.
• MTX Placebo — DRUG
  MTX placebo administered orally once weekly.
• Folic Acid — DRUG
  Administered orally every day

Study Details

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).

Key Dates

Start date

Nov 30, 2012

Status verified

Sep 2019

Primary completion

Feb 28, 2015

Completion

Aug 31, 2015

Study Design

Enrollment

588 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Baricitinib + MTX
  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.
• Experimental: Baricitinib
  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.
• Active Comparator: MTX
  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.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) [ Time Frame: Week 24 ]

Locations (47)

Find similar trials in Glendale, AZ

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