NCT01195987

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 8, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

September 3, 2010

Last Update Submit

September 7, 2010

Conditions

Hepatitis C Patients

Keywords

Hepatitis CArthritis

Study Arms (2)

Hepatitis C with Arthritis

Hepatitis C without Arthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hepatitis positive patients with and without osteoarthritis, with a group of Hepatitis C negative and no osteoarthritis to serve as controls.

You may qualify if:

  • 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.
  • normal healthy controls- Hep C neg and without osteoarthritis (OA).

You may not qualify if:

  • HIV patients
  • Those with concomitant alcoholic liver disease
  • Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rheumatic Disease, Allergy & Immunology

Kansas City, Missouri, 64111, United States

RECRUITING

MeSH Terms

Conditions

Hepatitis CArthritis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Nabih I Abdou, MD, PhD

    Center for Rheumatic Disease, Allergy & Immunology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabih I Abdou, MD, PhD

CONTACT

816-531-0930

Cindy A Greenwell, RN, BSN, CCRC

CONTACT

816-531-0930cindy@centerforrheumatic.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2010

First Posted

September 8, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations

US(1)