A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)
Launched by ABBVIE · Apr 4, 2017
Trial Information
Current as of June 18, 2025
Completed
Keywords
ClinConnect Summary
The study includes a 35-day screening period, a 56-week blinded period (Period 1), a long-term extension period of up to a total treatment duration of approximately 5 years (Period 2), a 30-day follow-up call or visit, and a 70-day follow-up call.
Period 1 includes 24 weeks of randomized, double-blind, placebo-controlled and active comparator-controlled treatment followed by 32 weeks of active comparator-controlled upadacitinib; at Week 24 participants assigned to placebo will be switched to upadacitinib according to their randomization assignment.
Participants who meet eligibility criter...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria.
- • Participant has active disease at Baseline defined as \>= 3 tender joints (based on 68 joint counts) and \>= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits.
- * Presence of either at Screening:
- • 1. \>= 1 erosion on x-ray as determined by central imaging review or;
- • 2. high-sensitivity C-reactive protein (hs-CRP) \> laboratory defined upper limit of normal (ULN).
- • Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
- • Participant has had an inadequate response (lack of efficacy after a minimum 12 week duration of therapy) to previous or current treatment with at least 1 non-biologic DMARD at maximally tolerated dose (methotrexate (MTX), sulfasalazine (SSZ), leflunomide (LEF), cyclosporine, apremilast, bucillamin or iguratimod), or participant has an intolerance to or contraindication for DMARDs as defined by the investigator.
- • Participant who is on current treatment with concomitant non-biologic DMARDs at study entry must be on \<= 2 non-biologic DMARDs (except the combination of MTX and leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine, leflunomide, apremilast, hydroxychloroquine (HCQ) , bucillamine or iguratimod, and have been ongoing for \>= 12 weeks and at stable dose for \>= 4 weeks prior to the Baseline Visit. No other DMARDs are permitted during the study.
- i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply with this inclusion criterion must follow the procedure specified below or at least five times the mean terminal elimination half-life of a drug:
- • 1. \>= 8 weeks for LEF if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal or as per local label);
- • 2. \>= 4 weeks for all others.
- Exclusion Criteria:
- • Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, and filgotinib).
- • Current treatment with \> 2 non-biologic DMARDs; or use of DMARDs other than methotrexate, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine, or iguratimod; or use of methotrexate in combination with leflunomide.
- • History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than PsA (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis is permitted if documentation of change in diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia is permitted if documentation of change in diagnosis to PsA or documentation that the diagnosis of fibromyalgia was made incorrectly.
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
Peoria, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Covina, California, United States
Fullerton, California, United States
Hemet, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
La Mesa, California, United States
La Palma, California, United States
Los Angeles, California, United States
Mather, California, United States
San Leandro, California, United States
Upland, California, United States
Whittier, California, United States
Denver, Colorado, United States
Fort Collins, Colorado, United States
Lakewood, Colorado, United States
Stamford, Connecticut, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Debary, Florida, United States
Miami Lakes, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Ormond Beach, Florida, United States
Palm Harbor, Florida, United States
Pensacola, Florida, United States
Saint Petersburg, Florida, United States
Tamarac, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Zephyrhills, Florida, United States
Idaho Falls, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
Skokie, Illinois, United States
Vernon Hills, Illinois, United States
Bowling Green, Kentucky, United States
Paducah, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Cumberland, Maryland, United States
Wheaton, Maryland, United States
Boston, Massachusetts, United States
Mansfield, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Blanc, Michigan, United States
Lansing, Michigan, United States
Lansing, Michigan, United States
Saint Clair Shores, Michigan, United States
Duluth, Minnesota, United States
Saint Louis, Missouri, United States
Springfield, Missouri, United States
Kalispell, Montana, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
Freehold, New Jersey, United States
Toms River, New Jersey, United States
Toms River, New Jersey, United States
Las Cruces, New Mexico, United States
Santa Fe, New Mexico, United States
Lake Success, New York, United States
New York, New York, United States
Potsdam, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Leland, North Carolina, United States
Raleigh, North Carolina, United States
Minot, North Dakota, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Perrysburg, Ohio, United States
Vandalia, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Summerville, South Carolina, United States
Jackson, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Baytown, Texas, United States
Beaumont, Texas, United States
College Station, Texas, United States
Colleyville, Texas, United States
Corpus Christi, Texas, United States
Dallas, 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
Arlington, Virginia, United States
Chesapeake, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
South Charleston, West Virginia, United States
Franklin, Wisconsin, United States
San Miguel De Tucuman, Ciuadad Autonoma De Buenos Aires, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Caba, , Argentina
Rosario, Santa Fe, , Argentina
San Miguel De Tucuman, Latam, , Argentina
Santa Fe, , Argentina
Botany, New South Wales, Australia
Woodville, South Australia, Australia
Geelong, Victoria, Australia
Heidelberg West, Victoria, Australia
Brest, , Belarus
Grodno, , Belarus
Minsk, , Belarus
Genk, , Belgium
Banja Luka, Republika Srpska, Bosnia And Herzegovina
Mostar, , Bosnia And Herzegovina
Sarajevo, , Bosnia And Herzegovina
Aparecida De Goiania, Goias, Brazil
Goiânia, Goias, Brazil
Juiz De Fora, Minas Gerais, Brazil
Curitiba, Parana, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Ribeirao Preto, Sao Paulo, Brazil
Santo André, Sao Paulo, Brazil
Santo André, Sao Paulo, Brazil
Sao Paulo, , Brazil
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Winnipeg, Manitoba, Canada
Barrie, Ontario, Canada
Sainte Foy, Quebec, Canada
Trois Rivières, Quebec, Canada
ñuñoa, Region Metropolitana De Santiago, Chile
Providencia, , Chile
Santiago, , Chile
Santiago, , Chile
Vitacura Santiago, , Chile
Bengbu, Anhui, China
Beijing, Beijing, China
Shantou, Guangdong, China
Zhuzhou, Hunan, China
Baotou, Inner Mongolia, China
Linyi, Shandong, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Chengdu, Sichuan, China
Ningbo, Zhejiang, China
Huhehaote, , China
Kunming, , China
Nantong, , China
Soochow, , China
Urumqi, , China
Bogota, Cundinamarca, Colombia
Antioquia, , Colombia
Barranquilla, , Colombia
Chia, , Colombia
Medellín, , Colombia
Zagreb, Grad Zagreb, Croatia
Rijeka, Primorsko Goranska Zupanija, Croatia
Zagreb, , Croatia
Zagreb, , Croatia
Prague 4, Praha 4, Czechia
Prague 4, Praha 4, Czechia
Bruntál, , Czechia
Ostrava, , Czechia
Uherské Hradište, , Czechia
Tallinn, Harjumaa, Estonia
Tartu, Tartumaa, Estonia
Tallinn, , Estonia
Herne, Nordrhein Westfalen, Germany
Berlin Buch, , Germany
Dresden, , Germany
Duesseldorf, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Rendsburg, , Germany
Tuebingen, , Germany
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, Attiki, Greece
Athens, , Greece
Heraklion, , Greece
Larisa, , Greece
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Tuen Mun, , Hong Kong
Gyula, Bekes, Hungary
Budapest Iii, Pest, Hungary
Nyíregyháza, Szabolcs Szatmar Bereg, Hungary
Zalaegerszeg, Zala, Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Veszprem, , Hungary
Dublin, , Ireland
Limerick, , Ireland
Tel Aviv Yafo, Tel Aviv, Israel
Haifa, , Israel
Ramat Gan, , Israel
Naples, Campania, Italy
Reggio Emilia, Emilia Romagna, Italy
Rome, Lazio, Italy
Ancona, , Italy
Catania, , Italy
Nagoya Shi, Aichi, Japan
Fukuoka Shi, Fukuoka, Japan
Kitakyushu Shi, Fukuoka, Japan
Tsu Shi, Mie, Japan
Kawachinagano Shi, Osaka, Japan
Chuo Ku, Tokyo, Japan
Suwon Si, Gyeonggido, Korea, Republic Of
Jung Gu, Incheon Gwang Yeogsi, Korea, Republic Of
Adazi, , Latvia
Liepaja, , Latvia
Riga, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipeda, , Lithuania
Siauliai, , Lithuania
Vilnius, , Lithuania
Ipoh, Perak, Malaysia
Seremban, , Malaysia
Mexico City, Ciudad De Mexico, Mexico
Guadalajara, Jalisco, Mexico
Chihuahua, , Mexico
Leeuwarden, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Hamilton, Waikato, New Zealand
Auckland, , New Zealand
Auckland, , New Zealand
Nelson, , New Zealand
Timaru, , New Zealand
Forde, Sogn Og Fjordane, Norway
Trondheim, Sor Trondelag, Norway
Wrocław, Dolnoslaskie, Poland
Toruń, Kujawsko Pomorskie, Poland
Lodz, Lodzkie, Poland
Cracow, Malopolskie, Poland
Gdańsk, Pomorskie, Poland
Gdynia, Pomorskie, Poland
Katowice, Slaskie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Elblag, , Poland
Krakow, , Poland
Poznan, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Lisbon, Lisboa, Portugal
Lisbon, Lisboa, Portugal
Vila Nova De Gaia, Porto, Portugal
Lisboa, , Portugal
Lisbon, , Portugal
Loures, , Portugal
Viana Do Castelo, , Portugal
Carolina, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Korolev, Moskva, Russian Federation
Novosibirsk, Novosibirskaya Oblast, Russian Federation
Kazan, Tatarstan, Respublika, Russian Federation
Moscow, , Russian Federation
St. Petersburg, , Russian Federation
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Belgrade, Beograd, Serbia
Singapore, Central Singapore, Singapore
Singapore, , Singapore
Martin, , Slovakia
Nové Mesto Nad Váhom, , Slovakia
Pieštany, , Slovakia
Ljubljana, , Slovenia
Maribor, , Slovenia
Murska Sobota, , Slovenia
Port Elizabeth, Eastern Cape, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
A Coruña, A Coruna, Spain
Granada, , Spain
Madrid, , Spain
Madrid, , Spain
St. Gallen, Sankt Gallen, Switzerland
Fribourg, , Switzerland
Taichung City, Taichung, Taiwan
Taichung, , Taiwan
Taipei City, , Taiwan
Taipei City, , Taiwan
Taoyuan City, , Taiwan
Saricam Adana, Adana, Turkey
Sihhiye, Ankara, Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Meram Konya, , Turkey
Sakarya, , Turkey
Kharkiv, Kharkivska Oblast, Ukraine
Lviv, Lvivska Oblast, Ukraine
Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Christchurch, , United Kingdom
Coventry, , United Kingdom
Glasgow, , United Kingdom
Luton, , United Kingdom
Patients applied
Trial Officials
AbbVie Inc.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials