A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

Launched by HOFFMANN-LA ROCHE · Sep 24, 2010

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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).
• • Inadequate response to treatment with etanercept, infliximab, adalimumab, or golimumab because of inadequate efficacy.
• • Tumor necrosis factor (TNF) antagonist therapy must have been discontinued at least 8 weeks prior to baseline (etanercept 4 weeks).
• • Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4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/cyclooxygenase-2 \[COX-2\] 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.
• • Previous treatment with tocilizumab.
• • 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.