Upadacitinib for Rheumatoid Arthritis
(SELECT-COMPARE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
You will need to stop taking all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) except for methotrexate (MTX). If you have been on a biological disease-modifying anti-rheumatic drug (bDMARD), a washout period (time without taking certain medications) is required.
Is upadacitinib safe for humans?
Upadacitinib has a generally good safety profile but may increase the risk of herpes zoster (shingles) and should not be used with certain other medications. It is not recommended for people with active tuberculosis, serious infections, active cancer, or severe liver problems. Safety monitoring continues in long-term studies.12345
How is the drug Upadacitinib different from other rheumatoid arthritis treatments?
Upadacitinib is unique because it is an oral medication that selectively inhibits Janus kinase 1 (JAK-1), which helps reduce inflammation in rheumatoid arthritis. It has shown superior effectiveness compared to some other treatments like adalimumab and abatacept, especially in patients who did not respond well to methotrexate or other biologic drugs.13678
What data supports the effectiveness of the drug Upadacitinib for treating rheumatoid arthritis?
Who Is on the Research Team?
AbbVie Inc.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults with moderately to severely active rheumatoid arthritis who have been on a stable dose of methotrexate but haven't responded well to it. Participants must have at least 6 swollen and tender joints, evidence of bone erosion or positive RA markers, and may have had limited exposure to one other RA drug (not adalimumab). Those with other joint diseases or previous JAK inhibitor use are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive randomized treatment with upadacitinib, placebo, or adalimumab for up to 48 weeks, with potential switches based on response criteria
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term extension
Participants continue study treatment as assigned at the end of Period 1 for up to 5 years, with ongoing assessment of joint improvement
What Are the Treatments Tested in This Trial?
Interventions
- Adalimumab
- Placebo for Adalimumab
- Placebo for Upadacitinib
- Upadacitinib
Upadacitinib is already approved in European Union, United States, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois