A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 600
Summary
- Conditions
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit. Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio t...
The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit. Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups: Group 1: upadacitinib 30 mg QD (Period 1) ? upadacitinib 30 mg QD (Period 2) Group 2: upadacitinib 15 mg QD (Period 1) ? upadacitinib 15 mg QD (Period 2) Group 3: MTX (Period 1) ? upadacitinib 30 mg QD (Period 2) Group 4: MTX (Period 1) ? upadacitinib 15 mg QD (Period 2) Starting with implementation of Protocol Amendment 5, all participants in the extension period will receive open-label upadacitinib 15 mg QD, including those currently on upadacitinib 30 mg QD.
Tracking Information
- NCT #
- NCT02706951
- Collaborators
- Not Provided
- Investigators
- Study Director: AbbVie Inc. AbbVie
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