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NCT02813083 Clinical Trial

Detection of Pathological Lymphocytes in Patients With Autoimmune Disease

Arthritis, Rheumatoid Clinical Trial

Official title:
Detection of Pathological Lymphocytes in Patients With Autoimmune Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02813083
Other study ID # 20494
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2011
Est. completion date September 2023

Study information
Verified date April 2024
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study will help the investigators design a method to detect the disease-causing immune cells in patients with rheumatoid arthritis (RA). Such methods are not currently available, but if successful, would help scientists to better understand the causes of RA.

Description:

The investigators are interested in learning about the immune cells in the blood that contribute to disease in patients with rheumatoid arthritis (RA). They have developed a method for identifying a specific type of immune cells that can react against normal tissues in the body. In this study, the investigators will enroll RA patients from the University of Minnesota clinics, collect blood samples from enrolled patients, and process the blood samples to isolate DNA, RNA, serum, and blood cells. They will use the serum to detect whether specific autoantibodies (Anti-cyclic Citrullinated Peptide, or anti-CCP) are present. In cases where anti-CCP antibodies are detected, the investigators may quantify the numbers of immune cells present that contain receptors with the same anti-CCP specificity. They may also test whether the numbers of immune cells with these receptors correlate with measures of disease activity in RA patients.

Recruitment information / eligibility
Status Completed
Enrollment 129
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Diagnosis of rheumatoid arthritis Exclusion Criteria: - Use of rituximab immediately prior to visit - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention (observational)
No intervention (observational)

Locations
Country Name City State
United States University of Minnesota Department of Medicine Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary DAS28-ESR 6 months
See also
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