SclerodermaPhase 2NCT00005675
Oral Type I Collagen for Relieving Scleroderma
A Phase 2 study testing Oral bovine type I collagen in people with Scleroderma and Connective Tissue Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Connective Tissue Diseases
- What is being tested?
- Oral bovine type I collagen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2000to May 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Johns Hopkins University
Baltimore, Maryland, 21224
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston University School Of Medicine
Boston, Massachusetts, 02188
Medical University of South Carolina
Charleston, South Carolina, 29425
Wayne State University
Detroit, Michigan, 48201
University of Connecticut
Farmington, Connecticut, 06030-1310
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of California Los Angeles
Los Angeles, California, 90024
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
Beth Israel Medical Center
New York, New York, 10003
Virginia Mason Research Center
Seattle, Washington, 98101
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: 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.
Read the 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.
- Conditions
- Scleroderma, Connective Tissue Diseases
- Being tested
- Oral bovine type I collagen, Placebo
- Keywords
- Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter
- Medical subject headings
- Scleroderma, Diffuse, Connective Tissue Diseases, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral bovine type I collagenDrug
Also called CI
500 mcg of CI daily for 15 months
PlaceboDrug
CI placebo daily for 15 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive oral bovine type I collagen (CI) daily for 15 months Receives: Drug: Oral bovine type I collagen |
| 2 | Placebo comparator | Participants will receive placebo daily for 15 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease condition, as measured by physical exam, modified Rodnan skin score (MRSS), health assessment questionnaires, chest x-ray, and pulmonary function tests
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2000 (estimated)
- Study startApr 2000
- Primary completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- 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
- Investigators
- Arnold E. Postlethwaite, MD, Principal investigator, University of Tennessee at Memphis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005675
- Sponsor's protocol ID
- N01 AR92242
- Other IDs
- NIAMS-048
- Status last verified
- Mar 2008
- First submitted
- 26 May 2000
- Last updated
- 25 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
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.
PubMed 11177772Carbone 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.
PubMed 15334493Postlethwaite 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.
PubMed 18512816
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Trial of Oral Type I Bovine Collagen in Scleroderma
- ClinicalTrials.gov ID
- NCT00005675
- Acronym / sponsor ID
- N01 AR92242
- Conditions
- Scleroderma, Connective Tissue Diseases
- Keywords
- Systemic Scleroderma (SSc), Bovine Type I Collagen (CI), Multicenter
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- 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
- Study start
- Apr 2000
- Primary completion
- May 2005 (actual)
- First posted
- 29 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oral bovine type I collagenParticipants will receive oral bovine type I collagen (CI) daily for 15 months |
| 2 | Placebo comparator | Drug: PlaceboParticipants will receive placebo daily for 15 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral bovine type I collagenAlso: CI500 mcg of CI daily for 15 months | Drug | 1 |
| PlaceboCI placebo daily for 15 months | Drug | 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2010.
- Background: PubMed 11177772Postlethwaite AE. Can we induce tolerance in rheumatoid arthritis? Curr Rheumatol Rep. 2001 Feb;3(1):64-9. doi: 10.1007/s11926-001-0052-z.
- Background: PubMed 15334493Carbone 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.
- Derived from this study: PubMed 18512816Postlethwaite 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.
- Division of The Connective Tissue Research Group of the University of Tennessee, MemphisLink provided by the sponsor.
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold E. Postlethwaite, MD principal investigator
University of Tennessee at Memphis
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral bovine type I collagen in people with Scleroderma and Connective Tissue Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005675, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2010.