PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294-7201, United States
Tucson, Arizona 85724, United States
La Jolla, California 92037, United States
Long Beach, California 90806, United States
Torrance, California 90502, United States
Colorado Springs, Colorado 80920, United States
Jacksonville, Florida 32207, United States
Wheaton, Maryland 20902, United States
Kalamazoo, Michigan 49008, United States
Statesville, North Carolina 28625, United States
Summerville, South Carolina 29486, United States
Dallas, Texas 75231, United States
C.a.b.a., Buenos Aires F.D. 1431, Argentina
CABA, C1055AAF, Argentina
CABA, C1417EYG, Argentina
Vitória, Espírito Santo 29055-450, Brazil
Belo Horizonte, Minas Gerais 30130-100, Brazil
Juiz de Fora, Minas Gerais 36010-570, Brazil
Rio de Janeiro, Rio de Janeiro 22271-100, Brazil
São Jose Do Rio Preto, São Paulo 15090-000, Brazil
São Paulo, São Paulo 01244-030, Brazil
São Paulo, São Paulo 04032-060, Brazil
São Paulo, São Paulo 04039-901, Brazil
São Paulo, São Paulo 05403-900, Brazil
Rio Grande de Sul, 90560-030, Brazil
Santiago, Santiago Metropolitan 8330034, Chile
Bogota D.C., Cundinamarca 112201, Colombia
Bogota, Cundinamarca, Colombia
Beer Yaacov, 70300, Israel
Lebanon, Lebanon
Mexico City, Mexico City 14080, Mexico
San Luis Potosí City, 78213, Mexico
Trujillo, La Libertad 13001, Peru
Arequipa, 04001, Peru
Lima, 27, Peru
Bialystok, Podlaskie Voivodeship 15-351, Poland
Elblag, 82-300, Poland
Sopot, 81-759, Poland
Saint Petersburg, St.petersburg 197706, Russia
Moscow, 119049, Russia
Nizhny Novgorod, 603005, Russia
Novosibirsk, 630075, Russia
Petrozavodsk, 185000, Russia
Saint Petersburg, 198260, Russia
Bratislava - Petrzalka, 851 01, Slovakia
Bellville, Cape Town, Western Cape 7530, South Africa
Chiang Mai, 50200, Thailand
Poole, Dorset BH152JB, United Kingdom
Goodmayes, Essex IG3 8YB, United Kingdom
Liverpool, L9 7AL, United Kingdom
Newcastle upon Tyne, NE1 4LP, United Kingdom