A Study to Compare ABT-494 Monotherapy to Methotrexate Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate (SELECT-EARLY)

This is a randomized, double-blind study comparing ABT-494 monotherapy to Methotrexate (MTX) monotherapy in MTX-naïve subjects with moderately to severely active rheumatoid arthritis.


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 993 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects With Moderately to Severely Active Rheumatoid Arthritis
Actual Study Start Date: March 15, 2016
Estimated Primary Completion Date: July 11, 2018
Estimated Study Completion Date: March 28, 2021

Arm:
- Experimental: ABT-494 Dose B
- Active Comparator: Methotrexate
- Experimental: ABT-494 Dose A