NCT00779012

A Study of the Efficacy and Tolerance of Remicade in the Treatment of Active Ankylosing Spondylitis (Study P04042)(COMPLETED)

Post-Registration Open-Label, Non-Comparative, Multicenter Study of Rate of Efficacy and Tolerance of the Use of Anti-TNF Chimeric Monoclonal Antibodies (Remicade) in Treatment of Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to prove reasonability of registration in Russian federation this new indication (ankylosing spondylitis \[AS\]) through evaluation of safety and efficacy rate of Remicade 5mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
BIOLOGICAL	Infliximab	Remicade 5 mg/kg, given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks (maximum 9 infusions).

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2008-10-24
• Last updated: 2017-05-11