Clinical trial NCT00005675: Oral Type I Collagen for Relieving Scleroderma
Official title: Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scleroderma
Connective Tissue Diseases
Keywords: Systemic Scleroderma (SSc)
Bovine Type I Collagen (CI)
Multicenter
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Sponsor class: NIH
Collaborators: name: Wayne State University
name: University of California, Los Angeles
name: UTHSC
name: Medical University of South Carolina
name: Beth Israel Medical Center
name: University of Alabama at Birmingham
name: Johns Hopkins University
name: Georgetown University
name: Baltimore VA Medical Center
name: Northwestern University
First posted: 2000-05-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests
timeFrame: Measured at Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Farmington
country: United States
facility: University of Connecticut
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Boston University School Of Medicine
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Seattle
country: United States
facility: Virginia Mason Research Center
state: Washington
Study officials:
affiliation: University of Tennessee at Memphis
name: Arnold E. Postlethwaite, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.