A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapy
- Conditions
- Ankylosing SpondylitisMedDRA version: 14.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2009-017443-34-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 502
- adult patients, >/=18 years of age - diagnosis of definite ankylosing spondylitis, defined by modified New York criteria, `?¥ 3 months prior to baseline - active disease defined as BASDAI score of `?¥ 4.0 and spinal pain assessment score of `?¥40, on a 0-100 mm Visual Analogue Scale (VAS), at screening and baseline - inadequate response or intolerant to 1 or more current or previous NSAIDs
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- previous treatment with tocilizumab - previous treatment with TNF antagonist therapy - inflammatory rheumatic disease other than AS (psoriatic arthritis is allowed if patient also has definite AS as defined in inclusion criteria) - active, acute uveitis at baseline - major surgery (including joint surgery) within eight weeks prior to screening or planned major surgery within six month after randomisation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method