A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

Key facts

Study ID

NCT02675426

Run by

AbbVie

People needed

661

Starts

2015-12-17

Expected to finish

2022-03-10

Last updated by the study team

2023-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male or female, at least 18 years old.
• Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.
• Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
• Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
• Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.

You may not qualify if…

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
• Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.

Where it is running

• SunValley Arthritis Center, Lt /ID# 140452 — Peoria, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 138500 — Phoenix, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 139286 — Phoenix, Arizona, United States
• AZ Arthritis & Rheuma Research /ID# 138598 — Phoenix, Arizona, United States
• Arizona Research Center, Inc. /ID# 140448 — Phoenix, Arizona, United States
• University of Arizona Cancer Center - North Campus /ID# 140451 — Tucson, Arizona, United States
• Covina Arthritis Clinic /ID# 139881 — Covina, California, United States
• T. Joseph Raoof, MD, Inc. /ID# 140964 — Encino, California, United States
• Allergy and Rheum Med Clin /ID# 146082 — La Jolla, California, United States
• Pacific Arthritis Ctr Med Grp /ID# 138744 — Los Angeles, California, United States
• Robin K. Dore MD, Inc /ID# 138688 — Tustin, California, United States
• Inland Rheum Clin Trials Inc. /ID# 138853 — Upland, California, United States
• Denver Arthritis Clinic /ID# 139876 — Denver, Colorado, United States
• Clinical Res of West FL, Inc. /ID# 138854 — Clearwater, Florida, United States
• Ctr Arthritis & Rheumatic Dise /ID# 141696 — Miami, Florida, United States
• Medallion Clinical Research Institute, LLC /ID# 140074 — Naples, Florida, United States
• Suncoast Clinical Research /ID# 138633 — New Port Richey, Florida, United States
• Omega Research Consultants /ID# 139877 — Orlando, Florida, United States
• Arthritis Center, Inc. /ID# 141363 — Palm Harbor, Florida, United States
• Institute of Arthritis Res /ID# 138548 — Idaho Falls, Idaho, United States
• OrthoIllinois /ID# 139695 — Rockford, Illinois, United States
• Clinical Investigation Special /ID# 139696 — Skokie, Illinois, United States
• Springfield Clinic /ID# 138602 — Springfield, Illinois, United States
• Deerbrook Medical Associates /ID# 139694 — Vernon Hills, Illinois, United States
• AZ Arthritis and Rheum Assoc /ID# 148651 — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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