Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Launched by ABBVIE · May 13, 2021
Trial Information
Current as of May 28, 2025
Terminated
Keywords
ClinConnect Summary
Participants were randomly assigned at a ratio of 1:1:1:1:1 to ABBV-154 at either 40 mg, 150 mg, 340 mg, subcutaneously (SC) EOW; 340 mg SC every 4 weeks (E4W); or placebo SC EOW. Randomization was stratified by baseline glucocorticoid (yes/no); number of prior failed biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) (1; 2 or more); and prior anti-TNF failure (yes/no) and if yes, further stratification by prior adalimumab use (yes/no).
After 12 weeks, participants receiving placebo were re-randomized to receive ABBV-154 150 mg SC EOW or 340 mg SC EOW fo...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
- • Participant has \>= 6 swollen joints (based on 66 joint count) and \>=6 tender joints (based on 68 joint count) at baseline.
- • Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
- • Participants must be on stable dose of methotrexate (MTX).
- Exclusion Criteria:
- • - Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
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
Phoenix, Arizona, United States
Jonesboro, Arkansas, United States
Fullerton, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
La Palma, California, United States
Los Angeles, California, United States
Northridge, California, United States
Poway, California, United States
San Leandro, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
Tujunga, California, United States
Upland, California, United States
West Hills, California, United States
Denver, Colorado, United States
Bridgeport, Connecticut, United States
Stamford, Connecticut, United States
Lewes, Delaware, United States
Boca Raton, Florida, United States
Brandon, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Debary, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Palm Harbor, Florida, United States
Saint Petersburg, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Zephyrhills, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Gainesville, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Schaumburg, Illinois, United States
Skokie, Illinois, United States
Springfield, Illinois, United States
Granger, Indiana, United States
Iowa City, Iowa, United States
Paducah, Kentucky, United States
Monroe, Louisiana, United States
Hagerstown, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Grand Blanc, Michigan, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Hattiesburg, Mississippi, United States
Tupelo, Mississippi, United States
Saint Louis, Missouri, United States
Saint Louis, Missouri, United States
Kalispell, Montana, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Freehold, New Jersey, United States
Voorhees, New Jersey, United States
Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Las Cruces, New Mexico, United States
Orchard Park, New York, United States
Potsdam, New York, United States
Charlotte, North Carolina, United States
Leland, North Carolina, United States
Salisbury, North Carolina, United States
Minot, North Dakota, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Cranberry Township, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Columbia, South Carolina, United States
Jackson, Tennessee, United States
Allen, Texas, United States
Allen, Texas, United States
Carrollton, Texas, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Lufkin, Texas, United States
Mesquite, Texas, United States
Plano, Texas, United States
Red Oak, Texas, United States
San Antonio, Texas, United States
The Woodlands, Texas, United States
Tomball, Texas, United States
Waco, Texas, United States
Newport News, Virginia, United States
Spokane, Washington, United States
Botany, New South Wales, Australia
Paramatta, New South Wales, Australia
Maroochydore, Queensland, Australia
Woodville South, South Australia, Australia
Camberwell, Victoria, Australia
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Sainte Foy, Quebec, Canada
Trois Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Praha, , Czechia
Uherske Hradiste, , Czechia
Velke Bilovice, , Czechia
Herne, Nordrhein Westfalen, Germany
Berlin, , Germany
Hamburg, , Germany
Athens, Attiki, Greece
Heraklion, Kriti, Greece
Efkarpia (Thessalonikis), Thessaloniki, Greece
Thessaloniki, , Greece
Debrecen, Hajdu Bihar, Hungary
Budapest, Pest, Hungary
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Szekesfehervar, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Ramat Gan, Tel Aviv, Israel
Tel Aviv Yafo, Tel Aviv, Israel
Haifa, , Israel
Haifa, , Israel
Haifa, , Israel
Kfar Saba, , Israel
Rome, Lazio, Italy
Milan, Lombardia, Italy
Ancona, , Italy
Palermo, , Italy
Reggio Emilia, , Italy
Nagoya Shi, Aichi, Japan
Nagoya Shi, Aichi, Japan
Fukui Shi, Fukui, Japan
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Fukuoka Shi, Fukuoka, Japan
Asahikawa Shi, Hokkaido, Japan
Sapporo Shi, Hokkaido, Japan
Kato Shi, Hyogo, Japan
Sanuki Shi, Kagawa, Japan
Kochi Shi, Kochi, Japan
Kumamoto Shi, Kumamoto, Japan
Miyazaki Shi, Miyazaki, Japan
Sasebo Shi, Nagasaki, Japan
Nagaoka Shi, Niigata, Japan
Kawachinagano Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Sayama Shi, Saitama, Japan
Chuo Ku, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Sumida Ku, Tokyo, Japan
Shimonoseki Shi, Yamaguchi, Japan
Cheonan Si, Chungcheongnamdo, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Seoul, Seoul Teugbyeolsi, Korea, Republic Of
Daegu, , Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Almelo, , Netherlands
Amsterdam, , Netherlands
Maastricht, , Netherlands
Papatoetoe, Auckland, New Zealand
Timaru, Canterbury, New Zealand
Newtown, Wellington, New Zealand
Bydgoszcz, Kujawsko Pomorskie, Poland
Lodz, Lodzkie, Poland
Warszawa, Mazowieckie, Poland
Stalowa Wola, Podkarpackie, Poland
Bialystok, Podlaskie, Poland
Gdansk, Pomorskie, Poland
Warsaw, , Poland
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Moscow, Moskovskaya Oblast, Russian Federation
Korolev, Moskva, Russian Federation
Yekaterinburg, Sverdlovskaya Oblast, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Moscow, , Russian Federation
Pushkin, , Russian Federation
St. Petersburg, , Russian Federation
Martin, , Slovakia
Nove Mesto Nad Vahom, , Slovakia
Piestany, , Slovakia
Poprad, , Slovakia
Rimavska Sobota, , Slovakia
Santiago De Compostela, A Coruna, Spain
Sabadell, Barcelona, Spain
Málaga, Malaga, Spain
Bilbao, Vizcaya, Spain
A Coruna, , Spain
Madrid, , Spain
Madrid, , Spain
Sevilla, , Spain
Valencia, , Spain
Chia Yi, , Taiwan
New Taipei City, , Taiwan
Taipei City, , Taiwan
Taipei City, , Taiwan
Sihhiye, Ankara, Turkey
Ankara, , Turkey
Kocaeli, , Turkey
Kharkiv, , Ukraine
Khmelnytskyi, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
Vinnytsia, , Ukraine
Grand Blanc, Michigan, United States
Rome, Lazio, Italy
Warszawa, Mazowieckie, Poland
Korolev, Moskva, Russian Federation
La Mesa, California, United States
Woodland Hills, California, United States
Daytona Beach, Florida, United States
Hialeah, Florida, United States
Orlando, Florida, United States
Cumberland, Maryland, United States
Lansing, Michigan, United States
Charlotte, North Carolina, United States
Lubbock, Texas, United States
Tomball, Texas, United States
Saskatoon, Saskatchewan, Canada
Haifa, H Efa, Israel
Haifa, H Efa, Israel
Haifa, H Efa, Israel
Kfar Saba, Hamerkaz, Israel
Tel Aviv, Tel Aviv, Israel
Papatoetoe, Auckland, New Zealand
Bialystok, Podlaskie, Poland
Warsaw, , Poland
Malaga, , Spain
Taipei, , Taiwan
Kharkiv, , Ukraine
Kyiv, , Ukraine
Poltava, , Ukraine
Vinnytsia, , Ukraine
Vinnytsia, , Ukraine
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials