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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULAR classification criteria for RA
Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol or etanercept 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 CRP and ESR values

Exclusion criteria

other autoimmune comorbidity
lack of informed consent

Treatment and study plan

No intervention

Other

Observational study

Primary outcomes

Flow cytometry for the assessment of change in T cell subtypes

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2016
First posted: Aug 30, 2017
Registry last updated: Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed