A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study was to assess efficacy, including inhibition of radiographic progression, and safety with upadacitinib versus placebo and versus an active comparator, adalimumab, in adults with with moderately to severely active rheumatoid arthritis (RA) who are on a stable background of methotrexate (MTX and who have an inadequate response to MTX.

Key facts

Study ID

NCT02629159

Run by

AbbVie

People needed

1629

Starts

2015-12-01

Expected to finish

2027-09-30

Last updated by the study team

2025-08-05

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 RA for greater than or equal to 3 months.
• Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
• 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.
• At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
• Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
• Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

You may not qualify if…

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

Where it is running

• AZ Arthritis and Rheum Assoc /ID# 143130 — Mesa, Arizona, United States
• SunValley Arthritis Center, Lt /ID# 143123 — Peoria, Arizona, United States
• Elite Clinical Studies, LLC /ID# 144881 — Phoenix, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 143080 — Phoenix, Arizona, United States
• AZ Arthritis and Rheum Researc /ID# 143121 — Phoenix, Arizona, United States
• AZ Arthritis & Rheuma Research /ID# 143131 — Phoenix, Arizona, United States
• Arizona Research Center, Inc. /ID# 144877 — Phoenix, Arizona, United States
• AZ Arthritis & Rheum Research /ID# 156093 — Sun City, Arizona, United States
• University of Arizona Cancer Center - North Campus /ID# 143114 — Tucson, Arizona, United States
• Osteoporosis Medical Center /ID# 153935 — Beverly Hills, California, United States
• T. Joseph Raoof, MD, Inc. /ID# 144884 — Encino, California, United States
• Rheumatology Ctr of San Diego /ID# 153747 — Escondido, California, United States
• C.V. Mehta MD, Med Corporation /ID# 143116 — Hemet, California, United States
• Allergy and Rheum Med Clin /ID# 146083 — La Jolla, California, United States
• Kotha and Kotha /ID# 161046 — La Mesa, California, United States
• TriWest Research Associates- La Mesa /ID# 143115 — La Mesa, California, United States
• Valerius Med Grp & Res Ctr /ID# 143120 — Los Alamitos, California, United States
• Discovery MM Services, Inc /ID# 163504 — Los Angeles, California, United States
• Desert Medical Advances /ID# 143097 — Palm Desert, California, United States
• Sierra Rheumatology /ID# 155672 — Roseville, California, United States
• Robin K. Dore MD, Inc /ID# 143090 — Tustin, California, United States
• Medvin Clinical Research /ID# 148362 — Whittier, California, United States
• Arthritis Assoc & Osteo Ctr /ID# 143122 — Colorado Springs, Colorado, United States
• Arthritis and Rheum Clin N. CO /ID# 156094 — Fort Collins, Colorado, United States
• Achieve Clinical Research, LLC /ID# 143136 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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