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	Treatment or Intervention	Phase
Scleroderma Connective Tissue Diseases	Drug: Bovine type I collagen	Phase II

Further Study Details: 

Expected Total Enrollment:  168

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study chairs or principal investigators

Arnold E. Postlethwaite, MD,  Principal Investigator,  University of Tennessee at Memphis   

Study ID Numbers:  NIAMS-048; N01 AR-9-2242
Record last reviewed:  April 2004
Last Updated:  November 3, 2004
Record first received:  May 26, 2000
ClinicalTrials.gov Identifier:  NCT00005675
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08