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Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis

NCT ID: NCT00667134

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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

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Systemic Sclerosis

Keywords

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systemic sclerosis autoantibodies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Subjects with diffuse scleroderma

No interventions assigned to this group

2

Subjects with limited scleroderma

No interventions assigned to this group

3

Subjects without a fibrosing or autoimmune disease.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Fulfill the American College of Rheumatology criteria for systemic sclerosis or:
2. Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease

Exclusion Criteria

1. If the subject has systemic sclerosis resulting from an environmental exposure
2. If the subject has an autoimmune disease excluding scleroderma
3. If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV)
4. If the subject has been treated with cyclophosphamide in the past 8 weeks.
5. If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Kristine Phillips

clinical assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Julie A Konkle, BSN

Role: STUDY_DIRECTOR

University of Michigan

Locations

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University of Michigan Medical School

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00009559

Identifier Type: -

Identifier Source: org_study_id