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

Systemic Sclerosis Clinical Trial

Official title:

Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00667134
• Other study ID #: HUM00009559
• Status: Completed
• Phase: N/A
• First received: April 23, 2008
• Last updated: October 24, 2016
• Start date: March 2008
• Est. completion date: February 2012

Study information

• Verified date: October 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: February 2012
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
United States	University of Michigan Medical School	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulatory autoantibodies to the PDGF receptor		1 year	No
Secondary	Phosphorylation of the PDGF receptor in patients with systemic sclerosis		One year	No