Oral Type I Collagen for Relieving Scleroderma - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Wayne State University University of California, Los Angeles UTHSC MUSC Beth Israel Medical Center University of Alabama at Birmingham Johns Hopkins University Georgetown University Baltimore VA Medical Center Northwestern University
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00005675

Purpose

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.

Condition	Intervention	Phase
Scleroderma Connective Tissue Diseases	Drug: Oral bovine type I collagen Drug: Placebo	Phase II

MedlinePlus related topics: Connective Tissue Disorders Scleroderma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Enrollment:	168
Study Start Date:	April 2000
Estimated Study Completion Date:	April 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive oral bovine type I collagen (CI) daily for 15 months	Drug: Oral bovine type I collagen 500 mcg of CI daily for 15 months
2: Placebo Comparator Participants will receive placebo daily for 15 months.	Drug: Placebo CI placebo daily for 15 months

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of diffuse systemic scleroderma (by American College of Rheumatology criteria 1980) of 10 years or less
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:

Participation in another clinical research study involving evaluation of another investigational drug within 90 days prior to study entry
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005675

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90024
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030-1310
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University School Of Medicine
Boston, Massachusetts, United States, 02188
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Washington
Virginia Mason Research Center
Seattle, Washington, United States, 98101

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Wayne State University

University of California, Los Angeles

UTHSC

MUSC

Beth Israel Medical Center

University of Alabama at Birmingham

Johns Hopkins University

Georgetown University

Baltimore VA Medical Center

Northwestern University

Investigators

Principal Investigator:

Arnold E. Postlethwaite, MD

University of Tennessee at Memphis

More Information

Additional Information:

Division of The Connective Tissue Research Group of the University of Tennessee, Memphis This link exits the ClinicalTrials.gov site

Publications:

Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. Review.

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. No abstract available.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	UTHSC ( Arnold E. Postlethwaite, MD )
Study ID Numbers:	N01 AR92242, NIAMS-048
Study First Received:	May 26, 2000
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00005675 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Systemic Scleroderma (SSc)
Bovine Type I Collagen (CI)
Multicenter

Study placed in the following topic categories:

Skin Diseases
Connective Tissue Diseases
Scleroderma

Scleroderma, Diffuse
Scleroderma, Systemic
Scleroderma, Localized

Additional relevant MeSH terms:

Skin Diseases
Connective Tissue Diseases
Scleroderma, Localized

ClinicalTrials.gov processed this record on May 07, 2009