Oral Type I Collagen for Relieving Scleroderma

Scleroderma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005675
• Other study ID #: N01AR92242
• Secondary ID: NIAMS-048
• Status: Completed
• Phase: Phase 2
• First received: May 26, 2000
• Last updated: May 24, 2010
• Start date: April 2000

Study information

• Verified date: March 2008
• Source: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Drug:
• Oral bovine type I collagen
500 mcg of CI daily for 15 months
• Placebo
CI placebo daily for 15 months

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University School Of Medicine	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Wayne State University	Detroit	Michigan
United States	University of Connecticut	Farmington	Connecticut
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of California Los Angeles	Los Angeles	California
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Beth Israel Medical Center	New York	New York
United States	Virginia Mason Research Center	Seattle	Washington
United States	Georgetown University Medical Center	Washington	District of Columbia

Sponsors (11)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Baltimore VA Medical Center, Beth Israel Medical Center, Georgetown University, Johns Hopkins University, Medical University of South Carolina, Northwestern University, University of Alabama at Birmingham, University of California, Los Angeles, UTHSC, Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Carbone LD, McKown K, Pugazhenthi M, Barrow KD, Warrington K, Somes G, Postlethwaite AE. Dosage effects of orally administered bovine type I collagen on immune function in patients with systemic sclerosis. Arthritis Rheum. 2004 Aug;50(8):2713-5. — View Citation

Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Division of The Connective Tissue Research Group of the University of Tennessee, Memphis