NCT01282528

Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the predictive value of clinical, functional (HAQ), laboratory and US variables in relation to disease activity and radiographic outcome in patients with RA who start treatment with Remicade at 24 weeks.

Detailed description

This is an open-lable, single arm study of the ultrasonographic monitoring of response to infliximab in patients with rheumatoid arthritis. Approximately 120 subjects will be enrolled. Subjects will receive infliximab 3mg/kg intravenous infusion at 0, 2, 6 week, and then repeated every 8 weeks until 24 weeks. The efficacy assessment is observed by ACR response, HAQ, DAS28, sharp scores and US assessment at 0,2，6,14, 22, and 24weeks and ultrosonographic and radiographic assessments are conducted at 0, 6,and 24weeks. Subjects will be followed for AEs and SAEs up to 8 weeks following the last study treatment administration (see Section 6). The end of study is defined as the time the last subject completes the 24 weeks visit.

Conditions

• Rheumatoid Arthritis
• Ultrasonography
• Infliximab

Interventions

Type	Name	Description
BIOLOGICAL	infliximab	3mg/kg, at week 0, 2, 6, 14, 22

Timeline

• Start date: 2010-09-01
• First posted: 2011-01-25
• Last updated: 2011-01-25

Locations

1 site across 1 country: China