Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis (ULTRA)
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|ClinicalTrials.gov Identifier: NCT01282528|
Recruitment Status : Unknown
Verified January 2011 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : January 25, 2011
Last Update Posted : January 25, 2011
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Ultrasonography Infliximab||Biological: infliximab||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis|
|Study Start Date :||September 2010|
- 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 ]
- estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography [ Time Frame: 6, 24 weeks ]
- investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores
- 3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|