Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

NCT ID: NCT01195987

Last Updated: 2010-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-08-31

Brief Summary

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The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.

Detailed Description

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Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.

Conditions

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Hepatitis C Patients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatitis C with Arthritis

No interventions assigned to this group

Hepatitis C without Arthritis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment.
* Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment.
* 10 normal healthy controls- Hep C neg and without osteoarthritis (OA).

Exclusion Criteria

* HIV patients
* Those with concomitant alcoholic liver disease
* Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's Hospital

UNKNOWN

Sponsor Role collaborator

The Center for Rheumatic Disease, Allergy, & Immunology

OTHER

Sponsor Role lead

Responsible Party

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Center for Rheumatic Disease, Allergy, & Immunology

Principal Investigators

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Nabih I Abdou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Rheumatic Disease, Allergy & Immunology

Locations

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Center for Rheumatic Disease, Allergy & Immunology

Kansas City, Missouri, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nabih I Abdou, MD, PhD

Role: CONTACT

816-531-0930

Cindy A Greenwell, RN, BSN, CCRC

Role: CONTACT

816-531-0930

Facility Contacts

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Cindy A Greenwell, MD, PHD

Role: primary

816-531-0930

Other Identifiers

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09-290

Identifier Type: -

Identifier Source: org_study_id