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

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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 facts

Study ID

NCT02706847

Run by

AbbVie

People needed

499

Starts

2016-03-15

Expected to finish

2022-02-08

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
• Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
• Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
• Meets both of the following criteria:
• ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
• hsCRP ≥ 3mg/L at Screening Visit.

You may not qualify if…

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia [currently with active symptoms]). Current diagnosis of secondary Sjogren's Syndrome is permitted.

Where it is running

• AZ Arthritis and Rheum Assoc /ID# 148593 — Mesa, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 142816 — Phoenix, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 146075 — Phoenix, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 148592 — Phoenix, Arizona, United States
• Arizona Research Center, Inc. /ID# 142741 — Phoenix, Arizona, United States
• AZ Arthr & Rheum Research /ID# 155256 — Prescott, Arizona, United States
• AZ Arthritis & Rheum Research /ID# 156090 — Sun City, Arizona, United States
• NEA Baptist Clinic /ID# 149280 — Jonesboro, Arkansas, United States
• Covina Arthritis Clinic /ID# 142794 — Covina, California, United States
• Rheumatology Ctr of San Diego /ID# 153576 — Escondido, California, United States
• St. Joseph Heritage Healthcare /ID# 149273 — Fullerton, California, United States
• TriWest Research Associates- La Mesa /ID# 142792 — La Mesa, California, United States
• Arthritis & Osteo Medical Ctr /ID# 142770 — La Palma, California, United States
• Valerius Med Grp & Res Ctr /ID# 142799 — Los Alamitos, California, United States
• Pacific Arthritis Ctr Med Grp /ID# 142783 — Los Angeles, California, United States
• University of California, Los Angeles /ID# 148348 — Los Angeles, California, United States
• Desert Medical Advances /ID# 142765 — Palm Desert, California, United States
• Stanford University School of Med /ID# 142761 — Stanford, California, United States
• Robin K. Dore MD, Inc /ID# 150908 — Tustin, California, United States
• Inland Rheum Clin Trials Inc. /ID# 142787 — Upland, California, United States
• Medvin Clinical Research /ID# 142814 — Whittier, California, United States
• Arthritis Assoc & Osteo Ctr /ID# 142809 — Colorado Springs, Colorado, United States
• Denver Arthritis Clinic /ID# 142771 — Denver, Colorado, United States
• New England Research Associates, LLC /ID# 142763 — Bridgeport, Connecticut, United States
• Rheum Assoc of North Alabama /ID# 145959 — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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