Systemic SclerosisNCT00667134
Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis, run by University of Michigan at 1 site in United States.
Trial summary
This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Sclerosis
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Feb 2012
- Phase
- Observational
- 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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by subjects being biopsied.
Who may be able to join
- Fulfill the American College of Rheumatology criteria for systemic sclerosis or:
- Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease
Who cannot join
- If the subject has systemic sclerosis resulting from an environmental exposure
- If the subject has an autoimmune disease excluding scleroderma
- If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV)
- If the subject has been treated with cyclophosphamide in the past 8 weeks.
- If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical School
Ann Arbor, Michigan, 48103
About this study
Official title: Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis
This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening
Read the detailed description
Pilot study to assess whether patients with systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis autoantibodies
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with diffuse scleroderma | |
| 2 | Subjects with limited scleroderma | |
| 3 | Subjects without a fibrosing or autoimmune disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulatory autoantibodies to the PDGF receptor
Measured: 1 year
Secondary outcomes (1)
Phosphorylation of the PDGF receptor in patients with systemic sclerosis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Kristine Phillips, University of Michigan
- Investigators
- Kristine Phillips, MD, Principal investigator, University of MichiganJulie A Konkle, BSN, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00667134
- Sponsor's protocol ID
- HUM00009559
- Status last verified
- Oct 2016
- First submitted
- 23 Apr 2008
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT00667134
- Acronym / sponsor ID
- HUM00009559
- Conditions
- Systemic Sclerosis
- Keywords
- systemic sclerosis autoantibodies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Apr 2008 (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.
This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening
Detailed description
Pilot study to assess whether patients with systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with diffuse scleroderma |
| 2 | – | –Subjects with limited scleroderma |
| 3 | – | –Subjects without a fibrosing or autoimmune disease. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by subjects being biopsied.
Key inclusion criteria (2 listed)
- Fulfill the American College of Rheumatology criteria for systemic sclerosis or:
- Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease
Key exclusion criteria (5 listed)
- If the subject has systemic sclerosis resulting from an environmental exposure
- If the subject has an autoimmune disease excluding scleroderma
- If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV)
- If the subject has been treated with cyclophosphamide in the past 8 weeks.
- If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stimulatory autoantibodies to the PDGF receptor
Time frame: 1 year
1 secondary outcome
Phosphorylation of the PDGF receptor in patients with systemic sclerosis
Time frame: One year
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 26 Oct 2016.
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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.
Kristine Phillips, MD principal investigator
University of Michigan
Julie A Konkle, BSN study director
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University of Michigan at 1 site 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 2 inclusion and 5 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Stimulatory autoantibodies to the PDGF receptor (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2016.