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

Study Identifier
M23-700
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
2022-502578-18-00
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Study Details

Medical Condition
  • Rheumatoid Arthritis
  • Study Drug
  • Upadacitinib
  • Adalimumab
  • Upadacitinib Matching Placebo
  • Adalimumab Matching Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431
    Flagstaff, Arizona, United States, 86001-6299
    Status
    Not applicable
    Location
    Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018
    Glendale, Arizona, United States, 85306-9802
    Status
    Not applicable
    Location
    Sun Valley Arthritis Center Ltd. /ID# 254654
    Peoria, Arizona, United States, 85381
    Status
    Not applicable
    Location
    Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 253432
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 255021
    Phoenix, Arizona, United States, 85032
    Status
    Not applicable
    Location
    Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017
    Tucson, Arizona, United States, 85704
    Status
    Not applicable
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