A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.
Inclusion Criteria:
Exclusion Criteria:
Los Alamitos, California 90720, United States
San Antonio, Texas 78217, United States
Innsbruck, 6020, Austria
Curtiba, Paraná 80030-110, Brazil
Shanghai, 200127, China
Medellin-Antioquia, Colombia
Berlin, 10117, Germany
München, 80336, Germany
Würzburg, 97080, Germany
Debrecen, 4032, Hungary
Rome, Lazio 00161, Italy
Turin, Piedmont 10154, Italy
Culiacán, Sinaloa 80000, Mexico
Miexico City, 06700, Mexico
Lima, LIMA 14, Peru
Szczecin, 71-252, Poland
Warsaw, 02-637, Poland
Moscow, 105203, Russia
Moscow, 115522, Russia
Moscow, 115682, Russia
Moscow, 119049, Russia
Saint Petersburg, 195067, Russia
Tula, 300053, Russia
Voronezh, 394066, Russia
Yekaterinburg, 620102, Russia
Santander, Cantabria 39008, Spain
Las Palmas de Gran Canaria, Las Palmas 35016, Spain
Oviedo, Principality of Asturias 33006, Spain
Bangkok, 10400, Thailand
Songkhla, 90110, Thailand
Istanbul, 34098, Turkey (Türkiye)