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Comparing Upadacitinib and Adalimumab for Rheumatoid Arthritis Treatment

A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)

PHASE3 · AbbVie · NCT05814627

This study is testing whether a new medication called upadacitinib works better than adalimumab for adults with moderate to severe rheumatoid arthritis who haven't had enough relief from previous treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment480 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie (industry)
Drugs / interventionscertolizumab, golimumab, infliximab, adalimumab, methotrexate, upadacitinib
Locations218 sites (Flagstaff, Arizona and 217 other locations)
Trial IDNCT05814627 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of upadacitinib compared to adalimumab in adults with moderate to severe rheumatoid arthritis who have not responded adequately to a previous TNF-inhibitor treatment. Participants will be randomly assigned to receive either upadacitinib or adalimumab while continuing a stable dose of methotrexate. The study is double-blinded, meaning neither the participants nor the researchers will know which treatment is being administered. Approximately 480 participants will be enrolled across 250 sites globally, and the study will assess changes in disease activity and any adverse events associated with the treatments.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with rheumatoid arthritis for at least three months who have had an inadequate response or intolerance to one TNF-inhibitor while on stable methotrexate therapy.

Not a fit: Patients who have not been treated with a TNF-inhibitor or those with rheumatoid arthritis for less than three months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with rheumatoid arthritis who have not responded to existing therapies.

How similar studies have performed: Previous studies have shown promising results with similar treatment comparisons, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Diagnosis of Rheumatoid Arthritis (RA) for \>= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA.
* Treated for \>= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (only 1 of originator or biosimilar certolizumab pegol, etanercept, golimumab or infliximab) for RA, but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll. Prior administration of different biosimilar versions for the same originator TNFi or switching between originator and biosimilar version of the same originator TNFi are acceptable. Cycling between biosimilars of different originator TNF inhibitors is not acceptable.
* On oral or parenteral methotrexate (MTX) therapy \>= 3 consecutive months and on a stable prescription of 15 to 25 mg/week (or \>= 10 mg/week in participants intolerant of MTX at doses \>= 15 mg/week) for \>= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation.

  * For a Chinese, Japanese, Korean, or Taiwanese participant, a stable dose of MTX \>= 7.5 mg/week is acceptable.
  * Additional local requirements for MTX may apply.
* Meets both of the following disease activity criteria:

  * \>= 6 swollen joint (based on 66 joint counts) and \>= 6 tender joints (based on 68 joint counts) at screening and baseline;
  * High-sensitivity C-reactive protein (hsCRP) \>= 3 mg/L (central lab, upper limit of normal \[ULN\] 2.87 mg/L) at screening.

Exclusion Criteria:

* History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA).
* Prior exposure to any janus kinase (JAK) inhibitor.
* Prior exposure to adalimumab (original or biosimilar) or to any approved or investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol and golimumab.
* Prior exposure to an approved or investigational non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease modifying antirheumatic drug (tsDMARD).

Where this trial is running

Flagstaff, Arizona and 217 other locations

+168 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Rheumatoid Arthritis, RA, Upadacitinib, Adalimumab, Methotrexate, MTX, TNF Inhibitor

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.