A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)
Launched by ABBVIE · Mar 8, 2016
Trial Information
Current as of May 06, 2025
Completed
Keywords
ClinConnect Summary
The study includes a 35-day screening period; a 14-week randomized, double-blind, parallel-group, controlled treatment period (Period 1); a 246-week blinded extension period (Period 2); and a 30-day follow-up visit.
Participants who met eligibility criteria were to be randomized in a 2:2:1:1 ratio to one of four treatment groups:
* Group 1: upadacitinib 30 mg QD (Period 1) → upadacitinib 30 mg QD (Period 2)
* Group 2: upadacitinib 15 mg QD (Period 1) → upadacitinib 15 mg QD (Period 2)
* Group 3: MTX (Period 1) → upadacitinib 30 mg QD (Period 2)
* Group 4: MTX (Period 1) → upadacitinib 15 ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Diagnosis of RA for \>= 3 months.
- • Subjects must have been on oral or parenteral MTX therapy \>= 3 months and on a stable dose for \>= 4 weeks prior to first dose of study drug.
- • Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) \>= 4 weeks prior to first dose of study drug.
- • Meets the following minimum disease activity criteria: \>= 6 swollen joints (based on 66 joint counts) and \>= 6 tender joints (based on 68 joint counts) at Screening and Baseline Visits.
- Exclusion Criteria:
- • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- • Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).
- • Current diagnosis of inflammatory joint disease other than RA. 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
Mobile, Alabama, United States
Gilbert, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Jonesboro, Arkansas, United States
Hemet, California, United States
Colorado Springs, Colorado, United States
Fort Lauderdale, Florida, United States
Miami Springs, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Monroe, Louisiana, United States
Shreveport, Louisiana, United States
Mansfield, Massachusetts, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Albuquerque, New Mexico, United States
Las Cruces, New Mexico, United States
New Bern, North Carolina, United States
Vandalia, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
Carrollton, Texas, United States
College Station, Texas, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Lufkin, Texas, United States
Mesquite, Texas, United States
San Antonio, Texas, United States
San Marcos, Texas, United States
The Woodlands, Texas, United States
Tomball, Texas, United States
Waco, Texas, United States
Chesapeake, Virginia, United States
Franklin, Wisconsin, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Salta, , Argentina
Santa Fe, , Argentina
Camperdown, New South Wales, Australia
Wien, , Austria
Aalst, Oost Vlaanderen, Belgium
Genk, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Concepcion, , Chile
Puerto Varas, , Chile
Santiago, , Chile
Olomouc, Olomoucky Kraj, Czechia
Prague 4, Praha 4, Czechia
Prague 4, Praha 4, Czechia
Breclav, , Czechia
Uherské Hradište, , Czechia
Tartu, Tartumaa, Estonia
Tallinn, , Estonia
Athens, , Greece
Veszprém, Veszprem, Hungary
Budapest, , Hungary
Kistarcsa, , Hungary
Szekesfehervar, , Hungary
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Ramat Gan, , Israel
Catanzaro, Calabria, Italy
Verona, , Italy
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Iizuka Shi, Fukuoka, Japan
Takasaki, Gunma, Japan
Kochi Shi, Kochi, Japan
Kumamoto Shi, Kumamoto, Japan
Kumamoto Shi, Kumamoto, Japan
Nagasaki Shi, Nagasaki, Japan
Sasebo City, Nagasaki, Japan
Osaka Shi, Osaka, Japan
Hamamatsu, , Japan
Hyuga, , Japan
Nishimura, , Japan
Sanuki, , Japan
Sapporo, , Japan
Sapporo, , Japan
Shunan, , Japan
Takaoka, , Japan
Tokyo, , Japan
Yotsukaido, , Japan
Monterrey, Nuevo Leon, Mexico
Mexico City, , Mexico
Wrocław, Dolnoslaskie, Poland
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Białystok, Podlaskie, Poland
Gdansk, Pomorskie, Poland
Elblag, Warminsko Mazurskie, Poland
Poznań, Wielkopolskie, Poland
Lisbon, Lisboa, Portugal
Vila Nova De Gaia, Porto, Portugal
Lisboa, , Portugal
Porto, , Portugal
Carolina, , Puerto Rico
Ponce, , Puerto Rico
Ploiesti, , Romania
Moscow, Moskva, Russian Federation
Novosibirsk, Novosibirskaya Oblast, Russian Federation
Perm, Permskiy Kray, Russian Federation
Tver, Tverskaya Oblast, Russian Federation
Ivanovo, , Russian Federation
Moscow, , Russian Federation
Nizhnij Novgorod, , Russian Federation
Orenburg, , Russian Federation
Petrozavodsk, , Russian Federation
Samara, , Russian Federation
Ufa, , Russian Federation
Yaroslavl, , Russian Federation
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Novi Sad, Vojvodina, Serbia
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Barcelona, , Spain
Barcelona, , Spain
Sevilla, , Spain
Sevilla, , Spain
Valencia, , Spain
Osmangazi, Bursa, Turkey
Lviv, Lvivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Ivano Frankivsk, , Ukraine
Kiev, , Ukraine
Zaporizhia, , Ukraine
Patients applied
Trial Officials
AbbVie Inc.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials