A Phase 3 interventional study of infliximab in Ankylosing Spondylitis, sponsored by Centocor, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-17.
Sponsored by Centocor, Inc. · Phase 3, Interventional, and Treatment
A study of the safety and efficacy of Infliximab (Remicade) versus placebo in subjects with Ankylosing Spondylitis
This is a clinical research study that will determine if there is a reduction in the signs and symptoms (such as back pain and stiffness) of patients with ankylosing spondylitis with infliximab therapy. This study will also study the safety of infliximab in patients with ankylosing spondylitis. The effect of infliximab on physical function, damage to joints and the quality of life in patients with ankylosing spondylitis will also be studied. Subjects received infusions of either placebo at weeks 0, 2, 6, 12, 18 and 5 mg/kg infliximab at weeks 24, 26, 30 and every 6 weeks through week 96, or 5 mg/kg infliximab at weeks 1, 2, 6, 12, 18 and every 6 weeks through week 96
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 279 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Centocor, Inc. is the lead sponsor of 73 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24
No study locations are listed for this record.
This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.
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Centocor, Inc.