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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Kristine Phillips, University of Michigan
ClinicalTrials.gov Identifier:
NCT00667134
First received: April 23, 2008
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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.


Condition
Systemic Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Stimulatory autoantibodies to the PDGF receptor [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phosphorylation of the PDGF receptor in patients with systemic sclerosis [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

skin serum


Estimated Enrollment: 50
Study Start Date: March 2008
Study Completion Date: February 2012
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Subjects with diffuse scleroderma
2
Subjects with limited scleroderma
3
Subjects without a fibrosing or autoimmune disease.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667134

Locations
United States, Michigan
University of Michigan Medical School
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
University of Michigan
Pfizer
Investigators
Principal Investigator: Kristine Phillips, MD University of Michigan
Study Director: Julie A Konkle, BSN University of Michigan
  More Information

No publications provided

Responsible Party: Kristine Phillips, clinical assistant professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00667134     History of Changes
Other Study ID Numbers: HUM00009559
Study First Received: April 23, 2008
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
systemic sclerosis autoantibodies

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Sclerosis
Connective Tissue Diseases
Pathologic Processes
Skin Diseases
Autoantibodies
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014