Search / Trial NCT02706873

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
Launched by ABBVIE · Mar 8, 2016

Download PDF

Apply for Trial

Trial Information

Current as of June 20, 2025

Completed

Keywords

Musculoskeletal Disease Arthritis Joint Disease Anti Inflammatory Agents Antirheumatic Agents Abt 494 Upadacitinib

ClinConnect Summary

This study includes 2 periods (a 48-week double-blind treatment period and a long-term extension period) and a Japan substudy. In Period 1 participants will be randomized in a 1:1:1 ratio to treatment Groups 2, 3, and 4 below, except for participants from Japan, who will be randomized in a 2:1:1:1 ratio to Groups 1, 2, 3, and 4:

* Group 1: Upadacitinib 7.5 mg once daily (QD) monotherapy (participants in Japan only)
* Group 2: Upadacitinib 15 mg QD monotherapy
* Group 3: Upadacitinib 30 mg QD monotherapy
* Group 4: Methotrexate monotherapy

Rescue therapy is defined for Weeks 12 through 24,...

Gender

ALL

Eligibility criteria

Inclusion Criteria:
• Duration of symptoms consistent with RA for ≥ 6 weeks who also fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
• Naïve to Methotrexate (MTX) or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug.
• Participants with prior exposure to conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) other than MTX may be enrolled if completed the washout period.
* Participant meets both of 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.
• high sensitivity C reactive protein (hsCRP) ≥ 5 mg/L (central lab, upper limit of normal \[ULN\] 2.87 mg/L at Screening Visit.
• Greater than or equal to 1 bone erosion on x-ray (by local reading) OR in the absence of documented bone erosion, both positive rheumatoid factor (RF) and positive anti-cyclic citrullinated peptide (anti CCP) autoantibodies are required at Screening.
• Stable dose of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral corticosteroids (equivalent to prednisone ≤ 10 mg/day), or inhaled corticosteroids for stable medical conditions are allowed but must have been at a stable dose ≥ 1 week prior to the first dose of study drug.
Exclusion Criteria:
• Intolerant to Methotrexate (MTX).
• Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib).
• Prior exposure to any biologic disease-modifying anti-rheumatic drugs (bDMARDs).
• History of any arthritis with onset prior to age 17 years or current diagnosis, inflammatory joint disease other than RA (including but not limited to gout, systemic lupus erythematosus, psoriatic arthritis, axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis, reactive arthritis, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, fibromyalgia \[currently with active symptoms\]. Current diagnosis of secondary Sjogren's Syndrome is permitted.
• Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point, intra-bursa, or intra-tendon sheath corticosteroids in the preceding 8 weeks prior to the first dose of study drug.

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.

Locations

La Mesa, California, United States

Palm Desert, California, United States

Daytona Beach, Florida, United States

Miami, Florida, United States

Ormond Beach, Florida, United States

Palm Harbor, Florida, United States

Sarasota, Florida, United States

Zephyrhills, Florida, United States

Vernon Hills, Illinois, United States

Paducah, Kentucky, United States

Toms River, New Jersey, United States

Voorhees, New Jersey, United States

Minot, North Dakota, United States

Vandalia, Ohio, United States

Tulsa, Oklahoma, United States

Wexford, Pennsylvania, United States

Summerville, South Carolina, United States

Jackson, Tennessee, United States

Memphis, Tennessee, United States

Beaumont, Texas, United States

Corpus Christi, Texas, United States

Edinburg, Texas, United States

El Paso, Texas, United States

Houston, Texas, United States

Mesquite, Texas, United States

San Antonio, Texas, United States

San Marcos, Texas, United States

Waco, Texas, United States

Arlington, Virginia, United States

Capital Federal, Buenos Aires, Argentina

San Isidro, Buenos Aires, Argentina

Rosario, Santa Fe, Argentina

Buenos Aires, , Argentina

Cordoba, , Argentina

San Miguel De Tucuman, , Argentina

Camperdown, New South Wales, Australia

Maroochydore, Queensland, Australia

Woodville, South Australia, Australia

Hobart, Tasmania, Australia

Camberwell, Victoria, Australia

Minsk, , Belarus

Charleroi, Hainaut, Belgium

Aalst, Oost Vlaanderen, Belgium

Gent, Oost Vlaanderen, Belgium

Genk, , Belgium

Mons, , Belgium

Banja Luka, Republika Srpska, Bosnia And Herzegovina

Sarajevo, , Bosnia And Herzegovina

Goiânia, Goias, Brazil

Curitiba, Parana, Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

São Paulo, Sao Paulo, Brazil

Rio De Janeiro, , Brazil

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Edmonton, Alberta, Canada

Winnipeg, Manitoba, Canada

Thornhill, Ontario, Canada

Rimouski, Quebec, Canada

Temuco, Araucania, Chile

Providencia, Santiago, Chile

Puerto Varas, , Chile

Santiago, , Chile

Vina Del Mar, , Chile

Bengbu, Anhui, China

Xiamen, Fujian, China

Shantou, Guangdong, China

Bogota, Cundinamarca, Colombia

Barranquilla, , Colombia

Bogota, , Colombia

Bogotá, , Colombia

Bucaramanga, , Colombia

Split, , Croatia

Zagreb, , Croatia

Hlučín, Moravskoslezsky Kraj, Czechia

Olomouc, Olomoucky Kraj, Czechia

Prague 4, Praha 4, Czechia

Prague, Praha 4, Czechia

Zlín 1, Zlin, Czechia

Breclav, , Czechia

Brno, , Czechia

Bruntál, , Czechia

Slany, , Czechia

Uherské Hradište, , Czechia

Tallinn, Harjumaa, Estonia

Pärnu, , Estonia

Tallinn, , Estonia

Herne, Nordrhein Westfalen, Germany

Köln, Nordrhein Westfalen, Germany

Rendsburg, Schleswig Holstein, Germany

Hamburg, , Germany

Munich, , Germany

Athens, Attiki, Greece

Ciudad De Guatemala, , Guatemala

Hong Kong, , Hong Kong

Tuen Mun, , Hong Kong

Miskolc, Borsod Abauj Zemplen, Hungary

Budapest, Pest, Hungary

Szombathely, Vas, Hungary

Heviz, , Hungary

Kistarcsa, , Hungary

Szekesfehervar, , Hungary

Dublin, , Ireland

Ashkelon, , Israel

Haifa, , Israel

Ramat Gan, , Israel

Rozzano, Milano, Italy

Milan, , Italy

Pavia, , Italy

Verona, , Italy

Nagoya Shi, Aichi, Japan

Toyohashi Shi, Aichi, Japan

Ichihara, Chiba, Japan

Fukuoka Shi, Fukuoka, Japan

Asahikawa, Hokkaido, Japan

Kobe, Hyogo, Japan

Sagamihara Shi, Kanagawa, Japan

Osaka, Kawachinagano Shi, Japan

Kochi Shi, Kochi, Japan

Kumamoto Shi, Kumamoto, Japan

Sasebo City, Nagasaki, Japan

Nagaoka Shi, Niigata, Japan

Okayama Shi, Okayama, Japan

Hirakata Shi, Osaka, Japan

Takatsuki Shi, Osaka, Japan

Kawagoe Shi, Saitama, Japan

Shimotsuke Shi, Tochigi, Japan

Bunkyo Ku, Tokyo, Japan

Chuo Ku, Tokyo, Japan

Meguro Ku, Tokyo, Japan

Shinjuku Ku, Tokyo, Japan

Shimonoseki Shi, Yamaguchi, Japan

Beppu, , Japan

Chiba, , Japan

Fukui, , Japan

Fukuoka, , Japan

Kato, , Japan

Kurume, , Japan

Kyoto, , Japan

Miyagi, , Japan

Nagoya, , Japan

Nishimura, , Japan

Oita, , Japan

Osaka, , Japan

Sanuki, , Japan

Sapporo, , Japan

Sayama, , Japan

Sendai, , Japan

Takaoka, , Japan

Tokyo, , Japan

Yotsukaido, , Japan

Astana, , Kazakhstan

Karaganda, , Kazakhstan

Semey, , Kazakhstan

Shymkent, , Kazakhstan

Adazi, , Latvia

Kaunas, Kovno, Lithuania

Klaipeda, , Lithuania

Vilnius, , Lithuania

Cuauhtemoc, Ciudad De Mexico, Mexico

Mexico City, Ciudad De Mexico, Mexico

Chihuahua, , Mexico

Mexico City, , Mexico

Queretaro, , Mexico

Hamilton, Waikato, New Zealand

Auckland, , New Zealand

Nelson, , New Zealand

Timaru, , New Zealand

Wrocław, Dolnoslaskie, Poland

Warsaw, Mazowieckie, Poland

Gdynia, Pomorskie, Poland

Katowice, Slaskie, Poland

Elblag, Warminsko Mazurskie, Poland

Poznań, Wielkopolskie, Poland

Lisbon, Lisboa, Portugal

Vila Nova De Gaia, Porto, Portugal

Lisboa, , Portugal

Porto, , Portugal

Viana Do Castelo, , Portugal

Viseu, , Portugal

Ponce, , Puerto Rico

San Juan, , Puerto Rico

Bucharest, Bucuresti, Romania

Bucuresti, , Romania

Iasi, , Romania

Oradea, , Romania

Korolev, Moskva, Russian Federation

Moscow, Moskva, Russian Federation

Novosibirsk, Novosibirskaya Oblast, Russian Federation

Pyatigorsk, Stavropol Skiy Kray, Russian Federation

Kazan, Tatarstan, Respublika, Russian Federation

Tver, Tverskaya Oblast, Russian Federation

Moscow, , Russian Federation

Orenburg, , Russian Federation

Petrozavodsk, , Russian Federation

Ryazan, , Russian Federation

Samara, , Russian Federation

Ufa, , Russian Federation

Ulyanovsk, , Russian Federation

Voronezh, , Russian Federation

Belgrade, Beograd, Serbia

Novi Sad, Vojvodina, Serbia

Martin, , Slovakia

Nové Mesto Nad Váhom, , Slovakia

Partizanske, , Slovakia

Pieštany, , Slovakia

Puchov, , Slovakia

Stará Lubovna, , Slovakia

Topolcany, , Slovakia

Trencin, , Slovakia

Trnava, , Slovakia

Zvolen, , Slovakia

žiar Nad Hronom, , Slovakia

Ljubljana, , Slovenia

Pretoria, Gauteng, South Africa

Cape Town, Western Cape, South Africa

Stellenbosch, Western Cape, South Africa

Santander, Cantabria, Spain

A Coruna, , Spain

Barcelona, , Spain

Madrid, , Spain

Santiago De Compostela, , Spain

Fribourg, , Switzerland

Taichung City, Taichung, Taiwan

Taipei City, Taipei, Taiwan

Dalin, , Taiwan

La Marsa, , Tunisia

Manouba, , Tunisia

Sousse, , Tunisia

Tunis, , Tunisia

Osmangazi, Bursa, Turkey

Konak, Izmir, Turkey

Izmir, , Turkey

Lviv, Lvivska Oblast, Ukraine

Vinnytsia, Vinnytska Oblast, Ukraine

Ivano Frankivsk, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Zaporizhia, , Ukraine

Leicester, England, United Kingdom

London, London, City Of, United Kingdom

Edinburgh, , United Kingdom

Leeds, , United Kingdom

Portsmouth, , United Kingdom

Southampton, , United Kingdom

Patients applied

0 patients applied

Trial Officials

AbbVie Inc.

Study Director

AbbVie

Timeline

First submit

February 18, 2016

Trial launched

February 23, 2016

Trial updated

June 21, 2023

Estimated completion

Not reported

Similar Trials

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate Launched by ABBVIE · Mar 8, 2016

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate
Launched by ABBVIE · Mar 8, 2016