Oral Type I Collagen for Relieving Scleroderma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma

Conditions
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Scleroderma, Connective Tissue Diseases

Intervention / Treatment
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* Drug: Oral bovine type I collagen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive oral bovine type I collagen (CI) daily for 15 months | Drug: Oral bovine type I collagen<br>* 500 mcg of CI daily for 15 months<br>* Other names: CI;|
| Placebo Comparator: 2<br>Participants will receive placebo daily for 15 months. | Drug: Placebo<br>* CI placebo daily for 15 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter