Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
2000-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Participants will receive oral bovine type I collagen (CI) daily for 15 months
Oral bovine type I collagen
500 mcg of CI daily for 15 months
2
Participants will receive placebo daily for 15 months.
Placebo
CI placebo daily for 15 months
Interventions
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Oral bovine type I collagen
500 mcg of CI daily for 15 months
Placebo
CI placebo daily for 15 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable skin involvement by history or physical examination 6 months prior to study entry
* Stable modified Rodnan skin score (MRSS) for 1 month prior to study entry
* Stable MRSS of 16 or more at screening and stable MRSS between screening and baseline visit
* Agree to use acceptable forms of contraception
Exclusion Criteria
* Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
* Systemic sclerosis-like illnesses associated with environmental, ingested, or injected agents, such as L-tryptophan, tainted rapeseed oil, vinyl chloride, or bleomycin
* Limited and localized (morphea) or linear SSc
* Tenderness or swelling of the extremities (eosinophilic fasciitis)
* Pregnancy
* Use of certain medications
* Allergy to beef or dairy products
* Nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 week before baseline visit. Aspirin at 325 mg or less daily for stroke or heart attack prevention is allowed.
* Use of herbal and some alternative therapies
* Any organ transplant or stem cell transplant
18 Years
ALL
No
Sponsors
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Wayne State University
OTHER
University of California, Los Angeles
OTHER
UTHSC
UNKNOWN
Medical University of South Carolina
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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Responsible Party
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UTHSC
Principal Investigators
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Arnold E. Postlethwaite, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee at Memphis
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California Los Angeles
Los Angeles, California, United States
University of Connecticut
Farmington, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Boston University School Of Medicine
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Beth Israel Medical Center
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Virginia Mason Research Center
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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NIAMS-048
Identifier Type: -
Identifier Source: secondary_id
N01 AR92242
Identifier Type: -
Identifier Source: org_study_id
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