Detection of Pathological Lymphocytes in Patients With Autoimmune Disease

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: No intervention (observational)

• Registration Number: NCT02813083
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Primary Completion: 2023-09
• Study Completion: 2023-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Diagnosis of rheumatoid arthritis

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Exclusion Criteria

• Use of rituximab immediately prior to visit
• Pregnancy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid Arthritis	No intervention (observational)	Rheumatoid arthritis patients

Primary Outcome Measures

Name	Time	Method
DAS28-ESR	6 months

Trial Locations

Locations (1)

University of Minnesota Department of Medicine; 🇺🇸 Minneapolis, Minnesota, United States