A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-BEYOND
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of 30 mg once daily (QD) and 15 mg QD upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who were on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.
The study objective of Period 2 (Week 24 to Week 240) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in participants with RA who completed Period 1.
This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo controlled treatment period (Period 1); a 216-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).
Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.
Participants who meet eligibility criteria will be randomized in a 2:2:1:1 ratio to one of four treatment groups:
- Group 1: Upadacitinib 30 mg QD (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
- Group 2: Upadacitinib 15 mg QD (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
- Group 3: Placebo (Day 1 to Week 12) → upadacitinib 30 mg QD (Week 12 and thereafter)
- Group 4: Placebo (Day 1 to Week 12) → upadacitinib 15 mg QD (Week 12 and thereafter)
Participants will continue stable dose of csDMARD therapy for the first 24 weeks of the study.
Participants who complete the Week 24 visit (end of Period 1) will enter the blinded long-term extension portion of the study, Period 2 and continue to receive the same dose of upadacitinib per original randomization assignment in a blinded manner. Starting at Week 24, at least 20% improvement in both swollen joint count (SJC) and tender joint count (TJC) compared to Baseline is required to remain on study drug. Starting at Week 24, initiation of or change in corticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, or adding or increasing doses in up to 2 csDMARDs (concomitant use of up to 2 csDMARDs except the combination of methotrexate and leflunomide) is allowed as per local label.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 499 participants
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 Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)
Actual Study Start Date: March 15, 2016
Actual Primary Completion Date: April 3, 2017
Estimated Study Completion Date: September 16, 2021
- Placebo Comparator: Placebo / Upadacitinib 15 mg
- Placebo Comparator: Placebo / Upadacitinib 30 mg
- Experimental: Upadacitinib 15 mg
- Experimental: Upadacitinib 30 mg
- Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs.
|Date last updated at source||2019-10-07|
|Study start date||2016-03-15|
|Estimated primary completion date||2017-04-03|