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| ID | Type | Description | Link |
|---|---|---|---|
| NIAMS-048 |
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| Name | Class |
|---|---|
| Wayne State University | OTHER |
| University of California, Los Angeles | OTHER |
| UTHSC | UNKNOWN |
| Medical University of South Carolina |
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Diffuse systemic sclerosis (SSc), or scleroderma, is a connective tissue disease causing damage to skin and other organs. The purpose of this study is to determine if taking oral bovine type I collagen (CI) will improve the condition of SSc patients.
SSc is a chronic connective tissue disease that is caused by excess collagen deposits that damage the skin and other organs. This study will determine if a daily oral dose of bovine CI will improve the condition of patients with SSc.
Patients will be randomly assigned to one of two groups. The first group will receive 500 mcg bovine CI daily for 15 months; the second group will receive placebo. Study visits will be conducted at Months 4, 8, 12, and 15. Patients will undergo physical examination and blood tests at each visit. Patients will also be evaluated for modified Rodnan skin score (MRSS) and will be given health assessment questionnaires. A chest x-ray will be conducted at study entry and pulmonary function tests will be conducted at study entry and Month 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will receive oral bovine type I collagen (CI) daily for 15 months |
|
| 2 | Placebo Comparator | Participants will receive placebo daily for 15 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral bovine type I collagen | Drug | 500 mcg of CI daily for 15 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests | Measured at Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold E. Postlethwaite, MD | University of Tennessee at Memphis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11177772 | Background | Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z. | |
| 15334493 | Background | Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. doi: 10.1002/art.20361. No abstract available. |
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| OTHER |
| Beth Israel Medical Center | OTHER |
| University of Alabama at Birmingham | OTHER |
| Johns Hopkins University | OTHER |
| Georgetown University | OTHER |
| Baltimore VA Medical Center | FED |
| Northwestern University | OTHER |
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| Placebo | Drug | CI placebo daily for 15 months |
|
| Los Angeles |
| California |
| 90024 |
| United States |
| University of Connecticut | Farmington | Connecticut | 06030-1310 | United States |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21224 | United States |
| Boston University School Of Medicine | Boston | Massachusetts | 02188 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Virginia Mason Research Center | Seattle | Washington | 98101 | United States |
| 18512816 | Derived | Postlethwaite AE, Wong WK, Clements P, Chatterjee S, Fessler BJ, Kang AH, Korn J, Mayes M, Merkel PA, Molitor JA, Moreland L, Rothfield N, Simms RW, Smith EA, Spiera R, Steen V, Warrington K, White B, Wigley F, Furst DE. A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum. 2008 Jun;58(6):1810-22. doi: 10.1002/art.23501. |
| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| D003240 | Connective Tissue Diseases |
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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