NCT00936143

Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis

An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Gu Jieruo · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.

Conditions

• Spondylitis

Interventions

Type	Name	Description
DRUG	infliximab	100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-09-01
• Completion: 2009-12-01
• First posted: 2009-07-09
• Last updated: 2016-01-26

Locations

1 site across 1 country: China