Oral Type I Collagen for Relieving Scleroderma

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Scleroderma; Connective Tissue Diseases

Treatments: Drug: Oral bovine type I collagen; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT00005675

NIAMS-048

N01 AR92242

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

168 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Participants will receive oral bovine type I collagen (CI) daily for 15 months

Treatment:

Drug: Oral bovine type I collagen

2

Placebo Comparator group

Description:

Participants will receive placebo daily for 15 months.

Treatment:

Drug: Placebo