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 naïve to TNF antagonist therapy
- Conditions
- Ankylosing SpondylitisMedDRA version: 12.1Level: LLTClassification code 10002556Term: Ankylosing spondylitis
- Registration Number
- EUCTR2009-017443-34-CZ
- 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:
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