A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)
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|ClinicalTrials.gov Identifier: NCT02629159|
Recruitment Status : Active, not recruiting
First Posted : December 14, 2015
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
Drug: Placebo for Adalimumab
Drug: Placebo for Upadacitinib
Participants with moderately to severely active rheumatoid arthritis (RA) on a stable dose of methotrexate with an inadequate response were randomized at 286 study sites in 41 countries.
This study is currently ongoing; results are reported as of the data cut-off date of 02 February 2018, when all participants were to have completed Week 26.
Participants were randomized in a 2:1:2 ratio to receive placebo, adalimumab, or upadacitinib. Randomization was stratified by prior exposure to biologic disease-modifying anti-rheumatic drug(s) (bDMARD) (yes/no) and geographic region.
Rescue therapy was offered to participants who met protocol-specified criteria at Weeks 14, 18, 22, or 26.