Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

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

Conditions studied: Rheumatoid Arthritis

In brief

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Key facts

Study ID

NCT05814627

Run by

AbbVie

People needed

487

Starts

2023-06-15

Expected to finish

2026-07-01

Last updated by the study team

2026-01-12

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018 — Glendale, Arizona, United States
• Sun Valley Arthritis Center Ltd. /ID# 254654 — Peoria, Arizona, United States
• Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432 — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021 — Phoenix, Arizona, United States
• Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017 — Tucson, Arizona, United States
• Arthritis and Rheumatism Associates /ID# 254013 — Jonesboro, Arkansas, United States
• Providence - St. Jude Medical Center /ID# 252690 — Fullerton, California, United States
• Newport Huntington Medical Group /ID# 252687 — Huntington Beach, California, United States
• Purushotham & Akther Kotha MD, Inc /ID# 252704 — La Mesa, California, United States
• Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692 — Los Alamitos, California, United States
• Rheumatology Center of San Diego /ID# 255038 — San Diego, California, United States
• Millennium Clinical Trials /ID# 252689 — Thousand Oaks, California, United States
• The Lundquist Institute at Harbor-UCLA Medical Center /ID# 252691 — Torrance, California, United States
• Comprehensive Rheumatology Center /ID# 252688 — Woodland Hills, California, United States
• University of Colorado Hospital /ID# 254617 — Aurora, Colorado, United States
• Denver Arthritis Clinic /ID# 254058 — Denver, Colorado, United States
• Tekton Research - Fort Collins - East Harmony Road /ID# 255036 — Fort Collins, Colorado, United States
• Arthritis and Rheumatic Disease Specialties /ID# 260583 — Aventura, Florida, United States
• Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733 — Boca Raton, Florida, United States
• Bay Area Arthritis and Osteo /ID# 254046 — Brandon, Florida, United States
• Believe Clinical Trial /ID# 262355 — Coral Springs, Florida, United States
• International Medical Research /ID# 254651 — Daytona Beach, Florida, United States
• Omega Research Debary, LLC /ID# 253735 — DeBary, Florida, United States
• Neoclinical Research /ID# 254622 — Hialeah, Florida, United States
• AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431 — Flagstaff, Arizona, United States

Full record on ClinicalTrials.gov

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