Connective Tissue Diseases, Scleroderma
Conditions
Keywords
Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter
Brief summary
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.
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.
Interventions
DRUGOral bovine type I collagen
500 mcg of CI daily for 15 months
DRUGPlacebo
CI placebo daily for 15 months
Sponsors
Wayne State University
University of California, Los Angeles
UTHSC
Medical University of South Carolina
Beth Israel Medical Center
University of Alabama at Birmingham
Johns Hopkins University
Georgetown University
Baltimore VA Medical Center
Northwestern University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Outcome results
None listed