A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone
Launched by ABBVIE · Feb 3, 2016
Trial Information
Current as of June 02, 2025
Completed
Keywords
ClinConnect Summary
This Phase 3 multicenter study includes two periods. Period 1 is a 12-week, randomized, double-blind, parallel-group, placebo-controlled period designed to compare the safety and efficacy of upadacitinib 30 mg once daily and upadacitinib 15 mg once daily versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis (RA) who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.
Period 2 is a 248-week blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of upadacitini...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult male or female, at least 18 years old.
- • Diagnosis of rheumatoid arthritis (RA) for greater than or equal to 3 months.
- • Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for greater than or equal to 3 months and on a stable dose for greater than or equal to 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.
- • Meets the following minimum disease activity criteria: greater than or equal to 6 swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- • Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled (up to 20% of study population) if they have documented evidence of intolerance to bDMARDs or limited exposure (less than 3 months) and have satisfied required washout periods.
- Exclusion Criteria:
- • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.
- • Subjects who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
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
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Covina, California, United States
Encino, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Tustin, California, United States
Upland, California, United States
Denver, Colorado, United States
Clearwater, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Idaho Falls, Idaho, United States
Rockford, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Vernon Hills, Illinois, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Paducah, Kentucky, United States
Portland, Maine, United States
Wheaton, Maryland, United States
Mansfield, Massachusetts, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Albany, New York, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Summerville, South Carolina, United States
Hendersonville, Tennessee, United States
Austin, Texas, United States
Carrollton, Texas, United States
College Station, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Killeen, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Waco, Texas, United States
Bothell, Washington, United States
Spokane, Washington, United States
Franklin, Wisconsin, United States
Buenos Aires, , Argentina
Cordoba, , Argentina
Coffs Harbour, New South Wales, Australia
Kogarah, New South Wales, Australia
Camberwell, Victoria, Australia
Geelong, Victoria, Australia
Vienna, , Austria
Wien, , Austria
Charleroi, Hainaut, Belgium
Gent, Oost Vlaanderen, Belgium
Brugge, , Belgium
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Sofia, , Bulgaria
Sofia, , Bulgaria
Winnipeg, Manitoba, Canada
St. John's, Newfoundland And Labrador, Canada
Sainte Foy, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Rijeka, Primorsko Goranska Zupanija, Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Hlučín, Moravskoslezsky Kraj, Czechia
Brno, , Czechia
Ostrava, , Czechia
Slany, , Czechia
Zlin, , Czechia
Tallinn, Harjumaa, Estonia
Pärnu, , Estonia
Tallinn, , Estonia
Helsinki, , Finland
Hyvinkaa, , Finland
Lappeenranta, , Finland
Marseille Cedex 08, Bouches Du Rhone, France
Chambray Les Tours, , France
Köln, Nordrhein Westfalen, Germany
Berlin, , Germany
Berlin, , Germany
Hamburg, , Germany
Planegg, , Germany
Heraklion, , Greece
Sha Tin, , Hong Kong
Budapest, , Hungary
Szekesfehervar, , Hungary
Dublin, , Ireland
Catanzaro, Calabria, Italy
Astana, , Kazakhstan
Incheon, Gwang Yeogsi, Korea, Republic Of
Suwon Si, Gyeonggido, Korea, Republic Of
Gwangju, Jeonranamdo, Korea, Republic Of
Seoul, Seongdong Gu, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Daegu, , Korea, Republic Of
Daejeon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Adazi, , Latvia
Klaipeda, , Lithuania
Vilnius, , Lithuania
Colonia Centro, Yucatan, Mexico
Mexico City, , Mexico
Nelson, , New Zealand
Toruń, Kujawsko Pomorskie, Poland
Grodzisk Mazowiecki, Mazowieckie, Poland
Białystok, Podlaskie, Poland
Elblag, Warminsko Mazurskie, Poland
Warsaw, , Poland
Lisbon, Lisboa, Portugal
Lisbon, Lisboa, Portugal
San Juan, , Puerto Rico
Cluj, , Romania
Ploiesti, , Romania
Sibiu, , Romania
Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Petrozavodsk, , Russian Federation
Samara, , Russian Federation
Ulyanovsk, , Russian Federation
Voronezh, , Russian Federation
Yaroslavl, , Russian Federation
Kosice, , Slovakia
Kosice, , Slovakia
Pieštany, , Slovakia
Pieštany, , Slovakia
Trnava, , Slovakia
Berea, Kwazulu Natal, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
Málaga, Malaga, Spain
Elche, , Spain
Madrid, , Spain
Santiago De Compostela, , Spain
Fribourg, , Switzerland
Taichung City, Taichung, Taiwan
Tainan City, Tainan, Taiwan
Taipei City, Taipei, Taiwan
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Taipei City, , Taiwan
Ankara, , Turkey
Kyiv, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Leicester, England, United Kingdom
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Edinburgh, , United Kingdom
Southampton, , United Kingdom
Warrington, , 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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