Stimulatory Autoantibodies to the Platelet-Derived Growth... | NCT00667134

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

NCT00667134

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

26Actual

Phase

Not provided

Conditions

Systemic Sclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Aug 2008Actual

Completion Date

Feb 2012Actual

First Submitted Date

Apr 23, 2008

First Submission Date that Met QC Criteria

Apr 23, 2008

First Posted Date

Apr 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Subjects with diffuse scleroderma
2		Subjects with limited scleroderma
3		Subjects without a fibrosing or autoimmune disease.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stimulatory autoantibodies to the PDGF receptor		1 year

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kristine Phillips, MD	University of Michigan	Principal Investigator
Julie A Konkle, BSN	University of Michigan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Medical School		Ann Arbor	Michigan	48103	United States

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided