T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy
1 other identifier
observational
122
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2016
CompletedFirst Submitted
Initial submission to the registry
August 24, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedAugust 30, 2017
August 1, 2017
3 years
August 24, 2017
August 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (3)
Healthy control
RA patients on anti-TNF therapy
RA patients on anti-IL-6R therapy
Interventions
Eligibility Criteria
In the cross-sectional analysis, 92 RA patients (who had been treated with biological therapy for more than six months) were evaluated. As a further control group (healthy controls), we enrolled 30 age- and gender-matched healthy volunteers.
You may qualify if:
- 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)
- negative history of RA symptoms
- negative status upon detailed physical and laboratory examination including normal CRP and ESR values
You may not qualify if:
- other autoimmune comorbidity
- lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Dulic S, Vasarhelyi Z, Sava F, Berta L, Szalay B, Toldi G, Kovacs L, Balog A. T-Cell Subsets in Rheumatoid Arthritis Patients on Long-Term Anti-TNF or IL-6 Receptor Blocker Therapy. Mediators Inflamm. 2017;2017:6894374. doi: 10.1155/2017/6894374. Epub 2017 Oct 25.
PMID: 29209104DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2017
First Posted
August 30, 2017
Study Start
January 2, 2013
Primary Completion
December 30, 2015
Study Completion
May 31, 2016
Last Updated
August 30, 2017
Record last verified: 2017-08