Status:
TERMINATED
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment ...
Detailed Description
This study was planned as a Phase II/III seamless, multicenter, randomized, double-blind, placebo-controlled study in patients with AS who were naïve to TNF antagonist therapy. The study consisted of ...
Eligibility Criteria
Inclusion
- 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)
- Traditional disease-modifying anti-rheumatic drugs (DMARDs) must be withdrawn for at least 4 weeks prior to baseline (methotrexate, sulfasalazine and hydroxychloroquine or chloroquine may be allowed if at stable dose for at least 4 weeks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/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 tumor necrosis factor (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
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT01209702
Start Date
September 1 2010
End Date
December 1 2011
Last Update
February 11 2013
Active Locations (139)
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1
Huntington Beach, California, United States, 92646
2
Aventura, Florida, United States, 33180
3
Orlando, Florida, United States, 32804
4
Atlanta, Georgia, United States, 30342