A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs

Launched by HOFFMANN-LA ROCHE · Sep 24, 2010

Keywords

ClinConnect Summary

This study was planned as a Phase II/III seamless, multicenter, randomized, double-blind, placebo-controlled study in patients with AS who were naïve to TNF antagonist therapy. The study consisted of 2 parts, each preceded by a screening visit and followed by a common open-label extension phase. Recruitment into Part 2 commenced after completion of enrollment for Part 1.

Part 1 was designed as a Phase II study exploring the efficacy and safety of tocilizumab therapy versus placebo. Part 1 was intended to determine whether Part 2 of the study would continue, based on a Week 12 analysis.

Pa...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • Adult patients, ≥ 18 years of age
• • Ankylosing Spondylitis as defined by the modified New York criteria for ≥ 3 months prior to baseline
• • Active disease at screening and baseline (Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] ≥4.0, spinal pain visual analog scale \[VAS\] ≥40)
• • Inadequate response or intolerant to 1 or more previous non-steroidal anti-inflammatory drugs (NSAIDs)
• • Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline)
• • Oral corticosteroids (≥ 10 mg/day prednisone or equivalent) and NSAIDs/COX-2 inhibitors must be at stable dose for at least 4 weeks prior to baseline
• Exclusion Criteria:
• • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after randomization
• • Total ankylosis of spine (as determined by investigator)
• • Inflammatory rheumatic disease other than ankylosing spondylitis
• • Active, acute uveitis at baseline
• • Treatment with tumor necrosis factor (TNF) antagonist therapy at any time prior to baseline
• • Intra-articular or tendon injections or parenteral corticosteroids within 4 weeks prior to screening
• • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• • Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection
• • History of or currently active primary or secondary immunodeficiency
• • Body weight \> 150 kg