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

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Tablet; Oral
• Upadacitinib — DRUG
  Tablet; Oral

Study Details

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are 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 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

Key Dates

Start date

Mar 15, 2016

Status verified

Jan 2023

Primary completion

Apr 3, 2017

Completion

Feb 8, 2022

Study Design

Enrollment

499 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Upadacitinib 15 mg
  Period 1: Participants receive upadacitinib 15 mg once daily for 24 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
• Experimental: Upadacitinib 30 mg
  Period 1: Participants receive upadacitinib 30 mg once daily for 24 weeks. Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.
• Placebo Comparator: Placebo / Upadacitnib 15 mg
  Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants will continue on upadacitinib 15 mg once daily from Week 24 to Week 260.
• Placebo Comparator: Placebo / Upadacitnib 30 mg
  Period 1: Participants receive placebo once daily for 12 weeks followed by upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue on upadacitinib 30 mg once daily until implementation of Protocol Amendment 4, then participants begin to receive upadacitinib 15 mg once daily up to Week 260.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (103)

Find similar trials in Huntsville, AL

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