T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy
NCT ID: NCT03266822
Last Updated: 2017-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
122 participants
OBSERVATIONAL
2013-01-02
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reconstitution of CD4+CD25highCD127low/-Tcell
NCT03736044
Characterization of Regulatory T Lymphocytes in the Synovial Fluid of Patients Affected by Rheumatoid Arthritis.
NCT03293667
Alterations in CD8αβ and CD8αα T Cell Levels in Patients With Rheumatoid Arthritis
NCT05827562
Detection of Pathological Lymphocytes in Patients With Autoimmune Disease
NCT02813083
Characterization of the Phenotypic Markers of B Cell Lymphocytes in Rheumatoid Arthritis
NCT03793270
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy control
No intervention
Observational study
RA patients on anti-TNF therapy
No interventions assigned to this group
RA patients on anti-IL-6R therapy
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention
Observational study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* lack of informed consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Szeged University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ETT-TUKEB905/PI/09
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.