Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spine Health Condition 2: null- Spondylitis Ankylosing
Conditions
Interventions
Intervention1: Tocilizumab: 8 mg/kg iv every 4 weeks for 24 weeks (Double-blind phase), 8 mg/kg iv every 4 weeks for 104 weeks (Open-label phase)
Control Intervention1: Placebo: Every 4 weeks for 24 w
Sponsors
F HoffmanLa Roche Ltd Switzerland
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Adult patients more than or equal to 18 years of age - Ankylosing Spondylitis as defined by the modified New York criteria for more than or equal to 3 months prior to baseline - Active disease at screening and baseline (BASDAI more than or equal to 4.0, spinal pain visual analog scale [VAS] more than or equal to 0) - Inadequate response or intolerant to 1 or more previous non-steroidal anti-rheumatic drugs (NSAIDs) - Inadequate response to treatment with etanercept, infliximab, adalimumab or golimumab because of inadequate efficacy - 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8 weeks prior to baseline (etanercept 4 weeks) - Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks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 (more than or equal to 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
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 RoActemra/Actemra - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving response of 20% improvement in ASsessment in AS International Working Group criteria (ASAS20)Timepoint: From baseline to week 12;Safety: Adverse events, laboratory parametersTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: anti-tocilizumab antibodiesTimepoint: From baseline to week 104;Long-term efficacy according to the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Metrology Index (BASMI)Timepoint: 104 weeks;Pharmacokinetics and pharmacodynamics (tocilizumab AUC, Cmax, T1/2, Cl, V; Interleukin-6; Soluble Il-6 receptor)Timepoint: 104 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, France, Germany, India, Italy, Lithuania, Mexico, Netherlands, Poland, Slovakia, Spain
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt. Ltd.
Outcome results
None listed