A Moderate to Severe Rheumatoid Arthritis Study

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Administered orally
• Baricitinib — DRUG
  Administered orally
• cDMARD — DRUG
  Participants will continue to take background cDMARD therapy throughout study.

Study Details

The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).

Key Dates

Start date

Jan 31, 2013

Status verified

Sep 2019

Primary completion

Jun 30, 2014

Completion

Sep 30, 2014

Study Design

Enrollment

527 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24. Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
• Experimental: Baricitinib 2 mg
  Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
• Experimental: Baricitinib 4 mg
  Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response - Placebo Versus Baricitinib 4 mg [ Time Frame: Week 12 ]

Locations (32)

Find similar trials in Glendale, AZ

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