A Study of RoActemra/Actemra (Tociliumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment
Information source: Hoffmann-La Roche
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Spondylitis, Ankylosing
Intervention: tocilizumab [RoActemra/Actemra] (Drug); Placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab[RoActemra/Actemra] (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Overall contact:
Please reference Study ID Number: NA22823, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com
Summary
This randomized, double-blind, placebo-controlled study will evaluate the safety and
efficacy of RoActemra/Actemra (tociliumab) in patients with ankylosing spondylitis who have
failed treatment with non-steroidal anti-inflammatory drugs and are naïve to 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.
Clinical Details
Official title: A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Proportion of patients achieving response of 20% improvement in ASsessment in AS International Working Group criteria (ASAS20)Safety: Adverse events, laboratory parameters
Secondary outcome: Radiographic change according to the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) and the Radiographic Ankylosing Spondylitis Spinal Score (RASSS)Change in physical function according to the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Bath Ankylosing Spondylitis Metrology Index (BASMI) Long-term efficacy (BASDAI, BASFI, BASMI) Pharmacokinetics and pharmacodynamics (tocilizumab AUC, Cmax, T1/2, Cl, V; Interleukin-6; Soluble Il-6 receptor) Immunogenicity: anti-tocilizumab antibodies
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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 (BASDAI >/= 4. 0, spinal pain VAS >/=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 (>/= 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 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
Locations and Contacts
Please reference Study ID Number: NA22823, Phone: 888-662-6728 (U.S. Only), Email: genentechclinicaltrials@druginfo.com Additional Information
Starting date: October 2010
Last updated: September 28, 2010
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