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 12 weeks (Part I), 8 mg/kg iv every 4 weeks for 24 weeks (Part II) intravenously
Control Intervention1: Placebo: every 4 weeks for 12 weeks (Pa
Sponsors
F Hoffman La Roche Ltd
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - Adult patients greater than or equal to 18 years of age - Ankylosing Spondylitis as defined by the modified New York criteria for greater than or equal to 3 months prior to baseline - Active disease at screening and baseline (BASDAI greater than or equal to 4.0, spinal pain VAS greater than or equal to 40) - Inadequate response or intolerant to 1 or more previous non-steroidal anti-rheumatic drugs (NSAIDs) - Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hyroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks prior to baseline) - Oral corticosteroids (greater 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 - Treatment with 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
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: 4 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in physical function according to the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Bath Ankylosing Spondylitis Metrology Index (BASMI)Timepoint: From baseline to Week 104;Immunogenicity: anti-tocilizumab antibodiesTimepoint: From baseline to week 208;Long-term efficacy (BASDAI, BASFI, BASMI)Timepoint: 208 weeks;Pharmacokinetics and pharmacodynamics (tocilizumab AUC, Cmax, T1/2, Cl, V; Interleukin-6; Soluble Il-6 receptor)Timepoint: 208 weeks;Radiographic change according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and the Radiographic Ankylosing Spondylitis Spinal Score (RASSS)Timepoint: From baseline to Week 104 | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, France, Germany, India, Italy, Lithuania, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, United Kingdom, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt Ltd.
Outcome results
None listed