A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Percentage of ASsessment in Ankylosing Spondylitis 20 (ASAS20) Responders at Week 12
ASAS20 was defined as an improvement of ≥ 20% and an absolute improvement of ≥ 10 units on a 0-100 visual analog scale (VAS) from Baseline to Week 12 in 3 of 4 domains: 1-Patient global assessment (with extremes labelled none and severe), 2-Pain assessment (average total and nocturnal pain scores with extremes labelled no pain and most severe pain), 3-Function (represented by the Bath Ankylosing Spondylitis (BAS) Functional Index [BASFI] average of 10 questions regarding ability to perform specific tasks with extremes labelled easy and impossible), and 4-Inflammation (average of the last 2 questions on the 6-question BAS Disease Activity Index [BASDAI] concerning morning stiffness intensity with extremes labelled none and very severe and duration between 0 and 2 or more hours); and the absence of deterioration (of at least 20% and absolute change of at least 10 units on a 0-100 mm scale) in the remaining domain.
Baseline to Week 12
No
Clinical Trials
Study Director
Hoffmann-La Roche
United States: Food and Drug Administration
WA22908
NCT01209689
October 2010
December 2011
Name | Location |
---|---|
Albany, Georgia 31701 | |
Fountain Valley, California 92708 | |
Miami, Florida 33176 | |
Philadelphia, Pennsylvania 19104 | |
Austin, Texas 78705 | |
Flint, Michigan 48532 | |
Kansas City, Kansas 66160 | |
Hackensack, New Jersey 07601 | |
Baltimore, Maryland 21287 | |
Charlotte, North Carolina | |
Coeur D'alene, Idaho 83814 |