Oral Type I Collagen for Relieving Scleroderma

NCT00005675 | Completed Phase 2 DMC

• 2 other identifiers: N01 AR92242NIAMS-048
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 12

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.

Conditions

Scleroderma; Connective Tissue Diseases

Keywords

Systemic Scleroderma (SSc); Bovine Type I Collagen (CI); Multicenter

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Oral bovine type I collagen

2

PLACEBO COMPARATOR

Participants will receive placebo daily for 15 months.

Drug: Placebo

Interventions

Oral bovine type I collagen DRUG

500 mcg of CI daily for 15 months

Also known as: CI

1

Placebo DRUG

CI placebo daily for 15 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (12)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

University of Connecticut

Farmington, Connecticut, 06030-1310, United States

Location

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Boston University School Of Medicine

Boston, Massachusetts, 02188, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Virginia Mason Research Center

Seattle, Washington, 98101, United States

Location

Related Publications (3)

• Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z.

  PMID: 11177772 BACKGROUND

• 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. doi: 10.1002/art.20361. No abstract available.

  PMID: 15334493 BACKGROUND

• Postlethwaite AE, Wong WK, Clements P, Chatterjee S, Fessler BJ, Kang AH, Korn J, Mayes M, Merkel PA, Molitor JA, Moreland L, Rothfield N, Simms RW, Smith EA, Spiera R, Steen V, Warrington K, White B, Wigley F, Furst DE. A multicenter, randomized, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease. Arthritis Rheum. 2008 Jun;58(6):1810-22. doi: 10.1002/art.23501.

  PMID: 18512816 DERIVED

MeSH Terms

Conditions

Scleroderma, Diffuse; Connective Tissue Diseases; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Arnold E. Postlethwaite, MD

  University of Tennessee at Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Expanded Access: Yes

Study Record Dates

• First Submitted: May 26, 2000
• First Posted: May 29, 2000
• Study Start: April 1, 2000
• Primary Completion: May 1, 2005
• Last Updated: May 25, 2010

Record last verified: 2008-03

Locations

US (12)