A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Adults With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate
Launched by ABBVIE · Dec 10, 2015
Trial Information
Current as of April 27, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called upadacitinib to see how well it works in treating adults with rheumatoid arthritis (RA) who are already taking a stable dose of methotrexate but are not getting enough relief from their symptoms. The trial compares upadacitinib to a placebo (a dummy treatment) and to another medication called adalimumab. Participants will be closely monitored to see if upadacitinib helps reduce inflammation, improve joint function, and prevent damage to bones over time.
To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with RA for at least three months. They should have been on methotrexate therapy for at least three months with a stable dose, and still have active symptoms, such as swollen or tender joints. Participants who qualify will take the study medication and will also receive folic acid or folinic acid throughout the trial. It's important to note that this trial is not currently recruiting new participants, but it is ongoing. Overall, participants can expect regular check-ups, assessments of their symptoms, and to contribute important information that may help improve treatment for others with RA.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adult male or female, at least 18 years old.
- • Diagnosis of RA for greater than or equal to 3 months.
- • Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25 mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses greater than or equal to 12.5 mg/week) for at least 4 weeks prior to the first dose of study drug. In addition all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
- • 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.
- • At least one of the following at Screening: greater than or equal to 3 bone erosions on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies.
- • Subjects with prior exposure to only one biological disease-modifying anti-rheumatic drugs (bDMARD) (except adalimumab) may be enrolled (up to 20% of total study population) if they have documented evidence of intolerance to the bDMARD or limited exposure (less than 3 months), but required washout periods need to be satisfied.
- • Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).
- Exclusion Criteria:
- • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
- • Subjects who have been exposed to adalimumab or who are considered inadequate responders to bDMARD therapy as determined by the Investigator.
- • History of inflammatory joint disease other than RA. History 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
Birmingham, Alabama, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Beverly Hills, California, United States
Encino, California, United States
Escondido, California, United States
Hemet, California, United States
La Jolla, California, United States
La Mesa, California, United States
La Mesa, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
Roseville, California, United States
Tustin, California, United States
Whittier, California, United States
Colorado Springs, Colorado, United States
Fort Collins, Colorado, United States
Aventura, Florida, United States
Boynton Beach, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Palm Harbor, Florida, United States
Saint Petersburg, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
Atlanta, Georgia, United States
Gainesville, Georgia, United States
Lawrenceville, Georgia, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Frederick, Maryland, United States
Wheaton, Maryland, United States
Worcester, Massachusetts, United States
Lansing, Michigan, United States
Saint Clair Shores, Michigan, United States
Duluth, Minnesota, United States
Tupelo, Mississippi, United States
Lincoln, Nebraska, United States
Omaha, Nebraska, United States
Toms River, New Jersey, United States
Toms River, New Jersey, United States
Voorhees, New Jersey, United States
Albuquerque, New Mexico, United States
Las Cruces, New Mexico, United States
Potsdam, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Leland, North Carolina, United States
New Bern, North Carolina, United States
Raleigh, North Carolina, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Tulsa, Oklahoma, United States
Duncansville, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Summerville, South Carolina, United States
Kingsport, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Edinburg, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Killeen, Texas, United States
Lubbock, Texas, United States
Lufkin, Texas, United States
Mesquite, Texas, United States
Missouri City, Texas, United States
Missouri City, Texas, United States
Missouri City, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Arlington, Virginia, United States
Chesapeake, Virginia, United States
Spokane, Washington, United States
Vancouver, Washington, United States
South Charleston, West Virginia, United States
Franklin, Wisconsin, United States
Capital Federal, Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Cordoba, , Argentina
Cordoba, , Argentina
Rosario, Santa Fe, , Argentina
Salta, , Argentina
San Fernando, , Argentina
San Miguel De Tucuman, , Argentina
San Miguel De Tucuman, , Argentina
Santa Fe, , Argentina
Camperdown, New South Wales, Australia
Camberwell, Victoria, Australia
Graz, , Austria
Minsk, , Belarus
Woluwe Saint Lambert, Bruxelles Capitale, Belgium
Charleroi, Hainaut, Belgium
Liège, Liege, Belgium
Gent, Oost Vlaanderen, Belgium
Mons, , Belgium
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Goiânia, Goias, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, Sao Paulo, Brazil
Rio De Janeiro, , Brazil
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland And Labrador, Canada
Hamilton, Ontario, Canada
Thornhill, Ontario, Canada
Sainte Foy, Quebec, Canada
Temuco, Araucania, Chile
Concepcion, , Chile
Osorno, , Chile
Providencia Santiago, , Chile
Puerto Varas, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Temuco, , Chile
Vina Del Mar, , Chile
Bogota, Cundinamarca, Colombia
Barranquilla, , Colombia
Bogota Dc, , Colombia
Bogota, , Colombia
Bucaramanga, , Colombia
Medellín, , Colombia
Rijeka, Primorsko Goranska Zupanija, Croatia
Split, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Hlučín, Moravskoslezsky Kraj, Czechia
Olomouc, Olomoucky Kraj, Czechia
Prague 2, Praha 2, Czechia
Prague 4, Praha 4, Czechia
Prague 4, Praha 4, Czechia
Prague 4, Praha 4, Czechia
Brno, , Czechia
Bruntál, , Czechia
Kladno, , Czechia
Ostrava, , Czechia
Pardubice, , Czechia
Aarhus N, Midtjylland, Denmark
Silkeborg, , Denmark
Tallinn, Harjumaa, Estonia
Tartu, Tartumaa, Estonia
Pärnu, , Estonia
Tallinn, , Estonia
Tallinn, , Estonia
Toulouse, Haute Garonne, France
Lille Cedex, Hauts De France, France
Montpellier Cedex 5, Herault, France
Bordeaux, , France
Caen, , France
Clermont Ferrand, , France
Marseille, , France
Paris, , France
Rennes, , France
Strasbourg, , France
Herne, Nordrhein Westfalen, Germany
Köln, Nordrhein Westfalen, Germany
Rendsburg, Schleswig Holstein, Germany
Chemnitz, , Germany
Hamburg, , Germany
Munich, , Germany
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, , Greece
Hong Kong, , Hong Kong
Tuen Mun, , Hong Kong
Miskolc, Borsod Abauj Zemplen, Hungary
Budapest Iii, Pest, Hungary
Szombathely, Vas, Hungary
Veszprém, Veszprem, Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Heviz, , Hungary
Kiskunhalas, , Hungary
Kistarcsa, , Hungary
Dublin, , Ireland
Tel Aviv Yafo, Tel Aviv, Israel
Haifa, , Israel
Haifa, , Israel
Haifa, , Israel
Ramat Gan, , Israel
Rozzano, Milano, Italy
Turin, Piemonte, Italy
Milan, , Italy
Verona, , Italy
Astana, , Kazakhstan
Karaganda, , Kazakhstan
Semey, , Kazakhstan
Shymkent, , Kazakhstan
Daegu, Daegu Gwang Yeogsi, Korea, Republic Of
Jung Gu, Daejeon Gwang Yeogsi, Korea, Republic Of
Jung Gu, Incheon Gwang Yeogsi, Korea, Republic Of
Gwangju, Jeonranamdo, Korea, Republic Of
Seongdong Gu, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Daegu, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Adazi, , Latvia
Daugavpils, , Latvia
Liepaja, , Latvia
Riga, , Latvia
Riga, , Latvia
Kovno, Kaunas, Lithuania
Vilnius, , Lithuania
Kota Bharu, Kelantan, Malaysia
Batu Caves, , Malaysia
Kuching, , Malaysia
Putrajaya, , Malaysia
Seremban, , Malaysia
Cuauhtemoc, Ciudad De Mexico, Mexico
Monterrey, Nuevo Leon, Mexico
Chihuahua, , Mexico
Mexico City, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
Hamilton, Waikato, New Zealand
Nelson, , New Zealand
Timaru, , New Zealand
Wrocław, Dolnoslaskie, Poland
Toruń, Kujawsko Pomorskie, Poland
Lublin, Lubelskie, Poland
Cracow, Malopolskie, Poland
Krakow, Malopolskie, Poland
Grodzisk Mazowiecki, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Białystok, Podlaskie, Poland
Gdynia, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Katowice, Slaskie, Poland
Bialystok, , Poland
Poznan, , Poland
Warsaw, , Poland
Lisbon, Lisboa, Portugal
Vila Nova De Gaia, Porto, Portugal
Braga, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Viana Do Castelo, , Portugal
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Bucharest, Bucuresti, Romania
Bucharest, Bucuresti, Romania
Bucuresti, , Romania
Bucuresti, , Romania
Bucuresti, , Romania
Iasi, , Romania
Oradea, , Romania
Korolev, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Perm, Permskiy Kray, Russian Federation
Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Tver, Tverskaya Oblast, Russian Federation
Ivanovo, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Moscow, , Russian Federation
Nizhnij Novgorod, , Russian Federation
Orenburg, , Russian Federation
Ryazan, , Russian Federation
St. Petersburg, , Russian Federation
St. Petersburg, , Russian Federation
Ufa, , Russian Federation
Ulyanovsk, , Russian Federation
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Novi Sad, Vojvodina, Serbia
Novi Sad, Vojvodina, Serbia
Martin, , Slovakia
Nové Mesto Nad Váhom, , Slovakia
Partizanske, , Slovakia
Pieštany, , Slovakia
Rimavska Sobota, , Slovakia
Sabinov, , Slovakia
Stará Lubovna, , Slovakia
Topolcany, , Slovakia
Zvolen, , Slovakia
Port Elizabeth, Eastern Cape, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Durban, Kwazulu Natal, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
Santander, Cantabria, Spain
A Coruna, , Spain
Cordoba, , Spain
Santiago De Compostela, , Spain
Santiago De Compostela, , Spain
Taichung City, Taichung, Taiwan
Taipei City, Taipei, Taiwan
Kaohsiung, , Taiwan
Kaohsiung, , Taiwan
New Taipei City, , Taiwan
Taichung City, , Taiwan
Taipei City, , Taiwan
Taoyuan City, , Taiwan
Cerrahpasa, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Kiev, Kyiv, Ukraine
Lviv, Lvivska Oblast, Ukraine
Vinnytsia, Vinnytska Oblast, Ukraine
Ivano Frankivsk, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Zaporizhia, , Ukraine
London, London, City Of, United Kingdom
Portsmouth, , 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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