T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: No intervention

• Registration Number: NCT03266822
• Lead Sponsor: Szeged University

Brief Summary

Data on the impact of biological therapies, especially of IL6-blocker treatment, on the T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve short-term follow-up.

Here, the investigator prospectively measure the percentages of 15 circulating T-cell subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43 IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological therapy. These are then compared with results obtained in early, untreated RA patients and gender-and-age matched healthy controls.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-02
• Primary Completion: 2015-12-30
• Study Completion: 2016-05-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-08-29
• Last Update Submitted: 2017-08-29
• Study First Posted: 2017-08-30
• Last Update Posted: 2017-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

Not provided

Exclusion Criteria

• other autoimmune comorbidity
• lack of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy control	No intervention	-

Primary Outcome Measures

Name	Time	Method
Flow cytometry for the assessment of change in T cell subtypes	Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.	The percentages of 15 circulating T-cell subtypes were measured using flow cytometry.