A Study in Moderate to Severe Rheumatoid Arthritis (RA-BEAM)
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.
Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active-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
Estimated Enrollment: 1280
Study Start Date: October 2012
Estimated Study Completion Date: September 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms:
- Placebo Comparator: Placebo
- Active Comparator: Adalimumab
- Experimental: Baricitinib
Related journal: Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis.
Category | Value |
---|---|
Date last updated at source | 2016-05-13 |
Study type(s) | Interventional |
Expected enrolment | 1307 |
Study start date | 2012-10-01 |
Estimated primary completion date | 2015-09-01 |