Rheumatoid Arthritis
Conditions
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.
Interventions
OTHERNo intervention
Observational study
Sponsors
Szeged University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed