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

October 24, 2016 updated by: Kristine Phillips, University of Michigan

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • University of Michigan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by subjects being biopsied.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Subjects with diffuse scleroderma
2
Subjects with limited scleroderma
3
Subjects without a fibrosing or autoimmune disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stimulatory autoantibodies to the PDGF receptor
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Phosphorylation of the PDGF receptor in patients with systemic sclerosis
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Pfizer

Investigators

  • Principal Investigator: Kristine Phillips, MD, University of Michigan
  • Study Director: Julie A Konkle, BSN, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00009559

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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