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

NCT00667134

Last updated date
Study Location
University of Michigan Medical School
Ann Arbor, Michigan, 48103, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Sclerosis
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Systemic SclerosisStimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis
NCT00667134
  1. Ann Arbor, Michigan
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis
Official Title Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis
Brief 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
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
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
skin serum
Sampling Method Non-Probability Sample
Study Population Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by subjects being biopsied.
Condition Systemic Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Subjects with diffuse scleroderma
  • 2
    Subjects with limited scleroderma
  • 3
    Subjects without a fibrosing or autoimmune disease.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 5, 2015)
26
Original Estimated Enrollment
 (submitted: April 23, 2008)
50
Actual Study Completion Date February 2012
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:Female
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00667134
Other Study ID Numbers HUM00009559
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kristine Phillips, University of Michigan
Study Sponsor University of Michigan
Collaborators Pfizer
Investigators
Principal Investigator:Kristine Phillips, MDUniversity of Michigan
Study Director:Julie A Konkle, BSNUniversity of Michigan
PRS Account University of Michigan
Verification Date October 2016