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

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Anti-Inflammatory Agents, Non-Steroidal

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• Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks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