Oral Type I Collagen for Relieving Scleroderma

This study has been completed.
Sponsor:
Collaborators:
Wayne State University
University of California, Los Angeles
UTHSC
MUSC
Beth Israel Medical Center
University of Alabama at Birmingham
Johns Hopkins University
Georgetown University
Baltimore VA Medical Center
Northwestern University
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00005675
First received: May 26, 2000
Last updated: May 24, 2010
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Scleroderma
Connective Tissue Diseases
Drug: Oral bovine type I collagen
Drug: Placebo
Phase 2

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: April 2000
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: CI
Placebo Comparator: 2
Participants will receive placebo daily for 15 months.
Drug: Placebo
CI placebo daily for 15 months

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005675

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California Los Angeles
Los Angeles, California, United States, 90024
United States, Connecticut
University of Connecticut
Farmington, Connecticut, United States, 06030-1310
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University School Of Medicine
Boston, Massachusetts, United States, 02188
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Washington
Virginia Mason Research Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Wayne State University
University of California, Los Angeles
UTHSC
MUSC
Beth Israel Medical Center
University of Alabama at Birmingham
Johns Hopkins University
Georgetown University
Baltimore VA Medical Center
Northwestern University
Investigators
Principal Investigator: Arnold E. Postlethwaite, MD University of Tennessee at Memphis
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arnold E. Postlethwaite, MD, UTHSC
ClinicalTrials.gov Identifier: NCT00005675     History of Changes
Other Study ID Numbers: N01 AR92242, NIAMS-048
Study First Received: May 26, 2000
Last Updated: May 24, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Systemic Scleroderma (SSc)
Bovine Type I Collagen (CI)
Multicenter

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014