Rheumatoid ArthritisNCT03266822
T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy
An observational study of Rheumatoid Arthritis, run by Szeged University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 122 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2013to 31 May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- other autoimmune comorbidity
- lack of informed consent
About this study
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- No intervention
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Not described Receives: Other: No intervention | |
| RA patients on anti-TNF therapy | Not described | |
| RA patients on anti-IL-6R therapy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow cytometry for the assessment of change in T cell subtypes
The percentages of 15 circulating T-cell subtypes were measured using flow cytometry.
Measured: Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start2 Jan 2013
- Primary completion30 Dec 2015
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266822
- Sponsor's protocol ID
- ETT-TUKEB905/PI/09
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request
Publications
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.
PubMed 29209104
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy
- ClinicalTrials.gov ID
- NCT03266822
- Acronym / sponsor ID
- ETT-TUKEB905/PI/09
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 2 Jan 2013 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | Other: No intervention |
| RA patients on anti-TNF therapy | – | – |
| RA patients on anti-IL-6R therapy | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- other autoimmune comorbidity
- lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study | Other | Healthy control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 29209104Dulic 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.
- Individual participant dataSharing planned: Undecided. Upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Szeged University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03266822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.