Status:
TERMINATED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response...
Eligibility Criteria
Inclusion
- 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- Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine, and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT01209689
Start Date
October 1 2010
End Date
December 1 2011
Last Update
January 17 2013
Active Locations (140)
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1
Huntington Beach, California, United States, 92646
2
Aventura, Florida, United States, 33180
3
Miami, Florida, United States, 33169
4
Orlando, Florida, United States, 32804