A Study in Moderate to Severe Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adalimumab — DRUG
  Administered SC
• Baricitinib — DRUG
  Administered orally
• Methotrexate — DRUG
  Administered orally
• Adalimumab Placebo — DRUG
  Adalimumab placebo administered SC.
• Baricitinib Placebo — DRUG
  Baricitinib placebo administered orally.

Study Details

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

Key Dates

Start date

Oct 31, 2012

Status verified

Sep 2019

Primary completion

Mar 31, 2015

Completion

Sep 30, 2015

Study Design

Enrollment

1,307 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.
• Experimental: Baricitinib
  Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.
• Active Comparator: Adalimumab
  Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.

Primary Outcome Measure

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

Locations (45)

Find similar trials in Glendale, AZ

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