A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs
Launched by ABBVIE · Mar 8, 2016
Trial Information
Current as of April 27, 2025
Completed
Keywords
ClinConnect Summary
This study includes a 35-day screening period; a 24-week randomized, double-blind, parallel-group, placebo controlled treatment period (Period 1); a 236-week blinded long-term extension period (Period 2); and a 30-day follow-up period (call or visit).
Period 1 consists of a 12-week double-blind, placebo-controlled treatment phase plus a 12-week double-blind phase where all participants were to receive upadacitinib; at Week 12 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.
Participants who meet eligibility criteria will be ran...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of rheumatoid arthritis (RA) for≥ 3 months.
- • Treated for ≥ 3 months with ≥ 1 bDMARD therapy, but continue to exhibit active RA or had to discontinue due to intolerability or toxicity, irrespective of treatment duration prior to the first dose of study drug.
- • Participant has been receiving csDMARD therapy ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide.
- * Meets both of the following criteria:
- • ≥ 6 swollen joints (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- • hsCRP ≥ 3mg/L at Screening Visit.
- Exclusion Criteria:
- • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- • History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia \[currently with active symptoms\]). Current diagnosis of secondary Sjogren's Syndrome is permitted.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Huntsville, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Prescott, Arizona, United States
Sun City, Arizona, United States
Jonesboro, Arkansas, United States
Covina, California, United States
Escondido, California, United States
Fullerton, California, United States
La Mesa, California, United States
La Palma, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
Stanford, California, United States
Tustin, California, United States
Upland, California, United States
Whittier, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Lewes, Delaware, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Palm Harbor, Florida, United States
Palm Harbor, Florida, United States
Pinellas Park, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
Decatur, Georgia, United States
Marietta, Georgia, United States
Boise, Idaho, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Monroe, Louisiana, United States
Shreveport, Louisiana, United States
Portland, Maine, United States
Wheaton, Maryland, United States
Mansfield, Massachusetts, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Tupelo, Mississippi, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Toms River, New Jersey, United States
Toms River, New Jersey, United States
Albany, New York, United States
New Hyde Park, New York, United States
Orchard Park, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Leland, North Carolina, United States
New Bern, North Carolina, United States
Raleigh, North Carolina, United States
Minot, North Dakota, United States
Cincinnati, Ohio, United States
Vandalia, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Kingsport, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
College Station, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Lufkin, Texas, United States
Mesquite, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Marcos, Texas, United States
Tomball, Texas, United States
Waco, Texas, United States
Bothell, Washington, United States
Spokane, Washington, United States
Vancouver, Washington, United States
South Charleston, West Virginia, United States
Franklin, Wisconsin, United States
Woodville, South Australia, Australia
Camberwell, Victoria, Australia
Vienna, Wien, Austria
Graz, , Austria
Vienna, , Austria
Wien, , Austria
Wien, , Austria
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Charleroi, Hainaut, Belgium
Gent, Oost Vlaanderen, Belgium
Genk, , Belgium
Oostende, , Belgium
Winnipeg, Manitoba, Canada
Ostrava, , Czechia
Uherské Hradište, , Czechia
Tartu, Tartumaa, Estonia
Tallinn, , Estonia
Hyvinkaa, , Finland
Lahti, , Finland
Orleans Cedex 2, Centre Val De Loire, France
Toulouse, Haute Garonne, France
Montpellier Cedex 5, Herault, France
Le Mans Cedex 9, Sarthe, France
Bordeaux, , France
Cahors, , France
Lyon, , France
Herne, Nordrhein Westfalen, Germany
Köln, Nordrhein Westfalen, Germany
Berlin, , Germany
Hamburg, , Germany
Hamburg, , Germany
Hamburg, , Germany
Munich, , Germany
Planegg, , Germany
Püttlingen, , Germany
Athens, Attiki, Greece
Veszprém, Veszprem, Hungary
Budapest, , Hungary
Debrecen, , Hungary
Gyula, , Hungary
Dublin, , Ireland
Tel Aviv Yafo, Tel Aviv, Israel
Haifa, , Israel
Haifa, , Israel
Seoul, Seongdong Gu, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Adazi, , Latvia
Riga, , Latvia
Riga, , Latvia
Timaru, , New Zealand
Wrocław, Dolnoslaskie, Poland
Krakow, Malopolskie, Poland
Warsaw, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Gdynia, Pomorskie, Poland
Vila Nova De Gaia, Porto, Portugal
Lisboa, , Portugal
San Juan, , Puerto Rico
Korolev, Moskva, Russian Federation
Kosice, , Slovakia
Kosice, , Slovakia
Pieštany, , Slovakia
Santander, Cantabria, Spain
Málaga, Malaga, Spain
A Coruna, , Spain
Madrid, , Spain
Santiago De Compostela, , Spain
Valencia, , Spain
Goteborg, , Sweden
Halmstad, , Sweden
Orebro, , Sweden
Vasteras, , Sweden
Basel, , Switzerland
Fribourg, , Switzerland
Ankara, , Turkey
Ankara, , Turkey
Samsun, , Turkey
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Chelmsford, , United Kingdom
Edinburgh, , United Kingdom
Ipswich, , United Kingdom
Portsmouth, , United Kingdom
Wirral, , United Kingdom
Patients applied
Trial Officials
AbbVie Inc.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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