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 Spondylitis; MedDRA version: 13.1Level: PTClassification code 10002556Term: Ankylosing spondylitisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2009-017443-34-LT
• Lead Sponsor: F. Hoffmann-La Roche Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 502

Inclusion Criteria

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

Exclusion Criteria

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
Main Objective: To assess the:<br>• Efficacy of treatment with TCZ 4 mg/kg and 8 mg/kg versus placebo in AS patients<br>who are naïve to treatment with TNF antagonist therapy with regard to the proportion of patients who achieve an ASAS20 response at week 12 (confirmation at week 24)<br>• Safety of TCZ 4 mg/kg and 8 mg/kg versus placebo with regard to AEs and<br>laboratory assessments;Secondary Objective: To assess the:<br>• Efficacy of treatment with regard to radiographic benefit and improvement of<br>physical function over 104 weeks<br>• Long term safety and efficacy of TCZ in patients with AS<br>• Pharmacokinetics and pharmacodynamics of TCZ in patients with AS<br>• Immunogenicity of TCZ in patients with AS;Primary end point(s): The primary endpoint in part 1 and part 2 is the proportion of patients with an ASAS 20 response at week 12.