A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis (RA) Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

Sponsor
AbbVie
Study ID
NCT02720523
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This is a randomized, double-blind study comparing ABT-494 to placebo in Japanese participants with moderately to severely active rheumatoid arthritis who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response. Following marketing approval of upadacitinib for rheumatoid arthritis in Japan, this study will become a post-marketing clinical study and include a long-term extension period.

Key Dates

Start date
Mar 22, 2016
Status verified
Jun 2023
Primary completion
Aug 3, 2017
Completion
Jun 7, 2022

Study Design

Enrollment
197 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo / Upadacitinib 7.5 mg
    Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive Upadacitinib 7.5 mg once daily for 248 weeks.
  • Experimental: Placebo / Upadacitinib 15 mg
    Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
  • Experimental: Placebo / Upadacitinib 30 mg
    Period 1: Participants will receive placebo once daily for 12 weeks. Period 2: Participants will receive upadacitinib 30 mg once daily until regulatory approval of RA indication in Japan at which point they will switch to receive upadacitinib 15 mg once daily. Participants will receive upadacitinib for 248 weeks.
  • Experimental: Upadacitinib 7.5 mg / Upadacitinib 7.5 mg
    Period 1: Participants will receive upadacitinib 7.5 mg once daily for 12 weeks. Period 2: Participants will receive upadacitinib 7.5 mg once daily for 248 weeks.
  • Experimental: Upadacitinib 15 mg / Upadacitinib 15 mg
    Period 1: Participants will receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants will receive upadacitinib 15 mg once daily for 248 weeks.
  • Experimental: Upadacitinib 30 mg / Upadacitinib 30 mg
    Period 1: Participants will receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants will receive upadacitinib 30 mg once daily until regulatory approval of RA indication in Japan at which point they will switch to receive upadacitinib 15 mg once daily. Participants will receive upadacitinib for 248 weeks.

Primary Outcome Measure

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

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