Oral Type I Collagen for Relieving Scleroderma

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

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.

Study Overview

• Status: Completed
• Conditions: Connective Tissue Diseases; Scleroderma
• Intervention / Treatment: Drug: Oral bovine type I collagen; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles
  • Connecticut
    • Farmington, Connecticut, United States, 06030-1310
      • University of Connecticut
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02188
      • Boston University School Of Medicine
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • New York
    • New York, New York, United States, 10003
      • Beth Israel Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Collaborators: Medical University of South Carolina; Johns Hopkins University; University of California, Los Angeles; Northwestern University; University of Alabama at Birmingham; Georgetown University; Wayne State University; Beth Israel Medical Center; Baltimore VA Medical Center; UTHSC
• Investigators: Principal Investigator: Arnold E. Postlethwaite, MD, University of Tennessee at Memphis

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2000
• Primary Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: May 26, 2000
• First Submitted That Met QC Criteria: May 26, 2000
• First Posted (Estimate): May 29, 2000

Study Record Updates

• Last Update Posted (Estimate): May 25, 2010
• Last Update Submitted That Met QC Criteria: May 24, 2010
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Multicenter; Systemic Scleroderma (SSc); Bovine Type I Collagen (CI)
• Additional Relevant MeSH Terms: Skin Diseases; Scleroderma, Systemic; Scleroderma, Diffuse; Connective Tissue Diseases; Scleroderma, Localized
• Other Study ID Numbers: N01 AR92242; NIAMS-048