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Oral Type I Collagen for Relieving Scleroderma

Primary Purpose

Scleroderma, Connective Tissue Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral bovine type I collagen
Placebo
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma focused on measuring Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama at Birmingham
  • University of California Los Angeles
  • University of Connecticut
  • Georgetown University Medical Center
  • Johns Hopkins University
  • Boston University School Of Medicine
  • Wayne State University
  • Beth Israel Medical Center
  • Medical University of South Carolina
  • University of Tennessee Health Science Center
  • The University of Texas Health Science Center at Houston
  • Virginia Mason Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

Participants will receive placebo daily for 15 months.

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 26, 2000
Last Updated
May 24, 2010
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborators
Wayne State University, University of California, Los Angeles, UTHSC, Medical University of South Carolina, Beth Israel Medical Center, University of Alabama at Birmingham, Johns Hopkins University, Georgetown University, Baltimore VA Medical Center, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00005675
Brief Title
Oral Type I Collagen for Relieving Scleroderma
Official Title
Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Connective Tissue Diseases
Keywords
Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive oral bovine type I collagen (CI) daily for 15 months
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo daily for 15 months.
Intervention Type
Drug
Intervention Name(s)
Oral bovine type I collagen
Other Intervention Name(s)
CI
Intervention Description
500 mcg of CI daily for 15 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
CI placebo daily for 15 months
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnold E. Postlethwaite, MD
Organizational Affiliation
University of Tennessee at Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of Connecticut
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1310
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Boston University School Of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02188
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11177772
Citation
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.
Results Reference
background
PubMed Identifier
15334493
Citation
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.
Results Reference
background
PubMed Identifier
18512816
Citation
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.
Results Reference
derived
Links:
URL
http://www.uthsc.edu/ctr/
Description
Division of The Connective Tissue Research Group of the University of Tennessee, Memphis

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Oral Type I Collagen for Relieving Scleroderma

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