A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.
Inclusion Criteria:
Exclusion Criteria:
Washington D.C., District of Columbia 20007, United States
Boca Raton, Florida 33486, United States
Rosario, Santa FE, S2000DSV, Argentina
Vancouver, British Columbia V6Z 1Y6, Canada
Toronto, Ontario M5G 1X5, Canada
Bad Abbach, 93077, Germany
Dresden, 01307, Germany
München, 80336, Germany
Tübingen, 72076, Germany
Rome, Lazio 00168, Italy
Milan, Lombardy 20122, Italy
Gunma, 371-8511, Japan
Hokkaido, 060-8543, Japan
Hokkaido, 060-8648, Japan
Kitakyushu-shi, 807-8556, Japan
Miexico City, 06700, Mexico
Bydgoszcz, 85-168, Poland
Gdansk, 80-952, Poland
Krakow, 31-121, Poland
Warsaw, 02-637, Poland
Barcelona, 08025, Spain