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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266822
• Other study ID #: ETT-TUKEB905/PI/09
• Status: Completed
• Phase: N/A
• First received: August 24, 2017
• Last updated: August 29, 2017
• Start date: January 2, 2013
• Est. completion date: May 31, 2016

Study information

• Verified date: August 2017
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 31, 2016
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• No intervention
Observational study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow cytometry for the assessment of change in T cell subtypes	The percentages of 15 circulating T-cell subtypes were measured using flow cytometry.	Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.