A Phase 4 interventional study of Infliximab in Ankylosing Spondylitis, sponsored by Merck Sharp & Dohme LLC. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-30.
Sponsored by Merck Sharp & Dohme LLC · Phase 4, Interventional, and Treatment
This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
Browse Spondylitis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Infliximab 5 mg/kg was administered as specified in the Summary of Product Characteristics for patients with ankylosing spondylitis
Drug: Infliximab
Infliximab 5 mg/kg administered as an intravenous perfusion over a period of 2 hours at Weeks 0, 2, 6, and 14, as indicated in the Summary of Product Characteristics
Also known as: Remicade, SCH 215596
Number of participants with clinical improvement assessed by the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) questionnaire
Time frame: Baseline and Week 15
No study locations are listed for this record.
This study is withdrawn, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC