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

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).

Timeline

Start

2004-10-01

Primary completion

2007-06-01

Completion

2007-06-01

Publications

• Results Bunchuk NV, Rumiantseva OA, Loginova EIu, Bochkova AG, Storozhakov GI, Ettinger OA, Kosiura SD, Kamalova RG, Valishina LM. [The efficacy and safety of infliximab in patients with ankylosing spondylitis: results of an open-labeled multicenter study]. Ter Arkh. 2010;82(10):41-6. Russian.

Drugs

Indications