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)
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)
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.
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.
Meets both of the following disease activity criteria:
Exclusion Criteria:
Flagstaff, Arizona 86001-6299, United States
Glendale, Arizona 85306-9802, United States
Phoenix, Arizona 85032, United States
Phoenix, Arizona 85032, United States
Tucson, Arizona 85704, United States
Los Alamitos, California 90720-5402, United States
Torrance, California 90502, United States
Fort Collins, Colorado 80528, United States
Boca Raton, Florida 33486, United States
Tampa, Florida 33606, United States
Tampa, Florida 33606, United States
Marietta, Georgia 30060, United States
Skokie, Illinois 60076, United States
Boston, Massachusetts 02149-4903, United States
Kalispell, Montana 59901, United States
Voorhees Township, New Jersey 08043, United States
Las Cruces, New Mexico 88011, United States
Allen, Texas 75013-6147, United States
Carrollton, Texas 75007, United States
Houston, Texas 77043, United States
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1015, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1428, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Aires F.D. 1958, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
San Miguel de Tucumán, Tucumán Province 4000, Argentina
São José do Rio Preto, São Paulo 15090-000, Brazil
Sofiya, Sofia 1463, Bulgaria
Sofiya, Sofia 1463, Bulgaria
Santiago, Region Metropolitana Santiago 8420383, Chile
Barranquilla, Atlántico 80002, Colombia
Bogotá, Cundinamarca 110221, Colombia
Bucaramanga, Santander Department 681004, Colombia
Krapinske Toplice, 49217, Croatia
Nice, Alpes-Maritimes 06001, France
Veszprém, Fejér 8200, Hungary
Milan, Milano 20122, Italy
Nagoya, Aichi-ken 455-8530, Japan
Kashiwa-shi, Chiba 277-8551, Japan
Asahikawa-shi, Hokkaido 078-8243, Japan
Kato-shi, Hyōgo 673-1462, Japan
Sanuki-shi, Kagawa-ken 769-2393, Japan
Sasebo-shi, Nagasaki 857-1195, Japan
Chuo-ku, Tokyo 104-8560, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Shimonoseki-shi, Yamaguchi 752-0976, Japan
Guadalajara, Jalisco 44650, Mexico
Mexico City, Mexico City 11850, Mexico
Ponte de Lima, Viana do Castelo District 4990-041, Portugal
Cheonan-si, Chungcheongnam-do 31151, South Korea
Gwangju, Gwangju Gwang Yeogsi 61748, South Korea
Santiago de Compostela, A Coruna 15706, Spain
Kings Lynn, Norfolk PE30 4ET, United Kingdom