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 (RA-BEAM)

NCT01710358 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	COMPLETED
Enrolment	1307
Start date	2012-10
Completion	2015-09

Conditions

• Rheumatoid Arthritis

Interventions

• Adalimumab
• Baricitinib
• Methotrexate
• Adalimumab Placebo
• Baricitinib Placebo

Primary outcomes

• Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20) — Week 12
  ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.

Countries

United States, Argentina, Belgium, Canada, China, Croatia, Czechia, France, Germany, Greece, Hungary, Japan, Latvia, Lithuania, Mexico, Poland, Portugal, Puerto Rico, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom