A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

Key facts

Study ID

NCT02706951

Run by

AbbVie

People needed

648

Starts

2016-03-23

Expected to finish

2022-08-10

Last updated by the study team

2024-01-30

Who can join

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

You may qualify if…

• Diagnosis of RA for >= 3 months.
• Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable dose for >= 4 weeks prior to first dose of study drug.
• Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.
• Meets the following minimum disease activity criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.

You may not qualify if…

• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
• Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.

Where it is running

• University of South Florida /ID# 146004 — Tampa, Florida, United States
• BayCare Medical Group, Inc. /ID# 151985 — Tampa, Florida, United States
• BayCare Medical Group, Inc. /ID# 163595 — Tampa, Florida, United States
• Jefrey D. Lieberman, MD, P.C. /ID# 151816 — Decatur, Georgia, United States
• Great Lakes Clinical Trials /ID# 150935 — Chicago, Illinois, United States
• PRN Professional Research Network of Kansas, LLC /ID# 143761 — Wichita, Kansas, United States
• Ochsner Clinic Foundation /ID# 153573 — Baton Rouge, Louisiana, United States
• The Arthritis & Diabetes Clinic, Inc. /ID# 160809 — Monroe, Louisiana, United States
• Vanguard Medical Research, LLC /ID# 153124 — Shreveport, Louisiana, United States
• Mansfield Health Center /ID# 161627 — Mansfield, Massachusetts, United States
• Quality Clinical Research Inc. /ID# 156415 — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center /ID# 146008 — Lebanon, New Hampshire, United States
• Albuquerque Clinical Trials, Inc /ID# 147618 — Albuquerque, New Mexico, United States
• Arthritis and Osteo Assoc /ID# 147177 — Las Cruces, New Mexico, United States
• Coastal Carolina Health Care /ID# 149275 — New Bern, North Carolina, United States
• STAT Research, Inc. /ID# 143770 — Vandalia, Ohio, United States
• Health Research Oklahoma /ID# 159550 — Oklahoma City, Oklahoma, United States
• Healthcare Research Consultant /ID# 147632 — Tulsa, Oklahoma, United States
• Innovative Clinical Research /ID# 143757 — Greenville, South Carolina, United States
• Nashville Arthritis and Rheumatology /ID# 162641 — Nashville, Tennessee, United States
• Tekton Research, Inc. /ID# 159554 — Austin, Texas, United States
• Diagnostic Group Integrated He /ID# 148725 — Beaumont, Texas, United States
• Trinity Universal Res Assoc /ID# 150138 — Carrollton, Texas, United States
• Arth and Osteo Clin Brazo Valley /ID# 160810 — College Station, Texas, United States
• SW FL Clin Res Ctr, Tampa, FL /ID# 143763 — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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