Oral Type I Collagen for Relieving Scleroderma
Scleroderma, Connective Tissue Diseases
About this trial
This is an interventional treatment trial for Scleroderma focused on measuring Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- University of California Los Angeles
- University of Connecticut
- Georgetown University Medical Center
- Johns Hopkins University
- Boston University School Of Medicine
- Wayne State University
- Beth Israel Medical Center
- Medical University of South Carolina
- University of Tennessee Health Science Center
- The University of Texas Health Science Center at Houston
- Virginia Mason Research Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Participants will receive oral bovine type I collagen (CI) daily for 15 months
Participants will receive placebo daily for 15 months.