Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
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|ClinicalTrials.gov Identifier: NCT02792699|
Recruitment Status : Completed
First Posted : June 7, 2016
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Drug: ABP 798
Drug: Rituximab (US)
Drug: Rituximab (EU)
This study was conducted at 57 centers in Bulgaria, Estonia, Germany, Hungary, Poland, and the United States (US).
Eligible participants were men and women aged 18 to 80 years, inclusive, with a diagnosis of rheumatoid arthritis (RA) for at least 6 months.
|Pre-assignment Details||Participants were randomized in a 1:1:1 ratio to 1 of 3 groups, stratified by geographic region (North America vs Eastern Europe vs Western Europe), seropositivity (rheumatoid factor [RF]-positive and/or cyclic citrullinated peptide [CCP]-positive vs RF-negative and CCP-negative), and number of prior biologic therapies used for RA (1 vs > 1).|