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

Last updated: August 29, 2017
Sponsor: Szeged University
Overall Status: Completed

Phase

N/A

Condition

Joint Injuries

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT03266822
ETT-TUKEB905/PI/09
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria for patients:

  • Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULARclassification criteria for RA

  • Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol oretanercept or infliximab or golimumab) or anti-IL-6R agent (tocilizumab) Inclusion Criteria for healthy controls:

  • negative history of RA symptoms

  • negative status upon detailed physical and laboratory examination including normal CRPand ESR values

Exclusion

Exclusion Criteria:

  • other autoimmune comorbidity

  • lack of informed consent

Study Design

Total Participants: 122
Study Start date:
January 02, 2013
Estimated Completion Date:
May 31, 2016