Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis (ULTRA)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis|
- The primary objective of this study is to evaluate the efficacy of treatment with infliximab on synovitis in RA patients using ultrasonography at 24 weeks. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography [ Time Frame: 6, 24 weeks ] [ Designated as safety issue: No ]
- investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores [ Designated as safety issue: No ]
- 3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index [ Designated as safety issue: No ]
|Study Start Date:||September 2010|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282528
|Contact: Xiaomei Leng, MDfirstname.lastname@example.org|
|Contact: Yan Zhao, MD||86-13910188862|
|Perking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Xiaomei Leng, MD +86-13681057089 email@example.com|
|Principal Investigator: Xiaomei Leng, MD|
|Principal Investigator:||Yan Zhao, MD||Perking Union Medical College hospital|
|Principal Investigator:||Xiaomei Leng, MD||Perking Union Medical College Hospital|