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| Name | Class |
|---|---|
| Shanghai Changzheng Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Shenzhen People's Hospital | OTHER |
| Changhai Hospital |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab | Biological | 3mg/kg, at week 0, 2, 6, 14, 22 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| estimate and visualize the efficacy of treatment with infliximab in RA patients using ultrasonography | 6, 24 weeks | |
| investigate the validity and sensitivity of ultrasonography assessment of joints inflammation in patients with RA compared with sharp scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomei Leng, MD | Contact | 86-13681057089 | lengxm@gmail.com | |
| Yan Zhao, MD | Contact | 86-13910188862 |
| Name | Affiliation | Role |
|---|---|---|
| Yan Zhao, MD | Perking Union Medical College hospital | Principal Investigator |
| Xiaomei Leng, MD | Perking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26781785 | Derived | Leng X, Xiao W, Xu Z, Zhu X, Liu Y, Zhao D, Xu H, Chen G, Yu W, Lu J, Wang J, Xia X, Li Y, Zhao Y, Tang H, Shi Y, Bao J, Chen L, Lin L, Zhou L, Zhang H, Zhao Y. Ultrasound7 versus ultrasound12 in monitoring the response to infliximab in patients with rheumatoid arthritis. Clin Rheumatol. 2016 Mar;35(3):587-94. doi: 10.1007/s10067-016-3176-2. Epub 2016 Jan 19. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| First People's Hospital of Foshan | OTHER |
| West China Hospital | OTHER |
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| 3) observe the relationship between ultrasonography assessment and DAS28, ACR20 and sharp scores and other clinical index |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |