Rheumatoid ArthritisLAdoRICNCT03953378
CD73+ Th1.17 in Rheumatoid Arthritis and Psoriatic Arthritis
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Prospective study to investigate the correlation between CD39/CD73 expression by the different T lymphocyte subpopulations in the blood and synovial fluid (if available) into patients with chronic inflammatory rheumatism RA and PsA types, with the rheumatic activity, the background therapy (with Methotrexate (MTX))… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis
- What is being tested?
- Multi-parametric Flow Cytometry analysis on patients and healthy donors samples
- How many people
- 41 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Dec 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic inflammatory rheumatism RA and PsA types with or without background therapy at the inclsuion
Who may be able to join
- Patients aged ≥ 18 years
- Patients naive to biologics
- Patients with RA fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria
- Patients with PsA fulfilling the Classification for PsA (CASPAR) criteria
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Rhumatologie, Centre Hospitalier Lyon-Sud (HCL)
Pierre-Bénite, 69495
About this study
Official title: Presence and Impact of CD73+ Th1.17 and of the CD39/CD73/Adenosine Cascade in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)
Prospective study to investigate the correlation between CD39/CD73 expression by the different T lymphocyte subpopulations in the blood and synovial fluid (if available) into patients with chronic inflammatory rheumatism RA and PsA types, with the rheumatic activity, the background therapy (with Methotrexate (MTX)) and the response to this treatment.
Read the detailed description
Th1.17 compose a recently described subset of highly polyfunctional and thus potentially more harmful CD4+ effector T cells (Teff) than classical Th17 as they co-produce interferon-γ (IFN-γ) and interleukin-17A (IL-17A). For this reason, Th1.17 rise increasing interest in RA and PsA since they seem involved in their pathophysiology. Hyper activation of Teff in RA and PsA results partly from a deficiency in regulatory mechanisms of Teff's pro-inflammatory functions. The ecto-nucleotidase CD73 delineates Teff enriched in Th1.17 features and acts as a regulatory mechanism for these pro-inflammatory cells. Considering that MTX, usually used as first line treatment of RA and PsA, increases extracellular concentrations of adenosine monophasphate (AMP) and immunosuppressive adenosine, the investigators hypothesized that CD4+CD73+ T cell effector population enriched in Th1.17 and Th17 cells may participate in the pathogenicity of RA and PsA but also in the resistance to MTX treatment through the specific expression of CD73 essential for Ado generation and which is down-regulated on proliferating T cells.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Being tested
- Multi-parametric Flow Cytometry analysis on patients and healthy donors samples
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-parametric Flow Cytometry analysis on patients and healthy donors samplesOther
Collection of venous blood (16 mL) and synovial fluid (when available) samples, for each patient, at inclusion and in the frame of the usual medical follow-up at 3 months and between 6 and 12 months, before the onset of MTX (untreated patients) or during the course of MTX treatment (MTX-treated patients).
Collection of anonymous healthy donors blood samples, age- and sex-matched, obtained from the Etablissement Français du Sang.
Multi-parametric Flow Cytometry analysis was performed on these samples to assess CD73 expression on total memory T cells and within T helper lymphocyte subsets, their cytokine production and AMPase functions. For FoxP3 intracellular staining, cells were treated using the FoxP3 Fixation and Permeabilization kit (Life Technologies), according to manufacturer instructions. Stainings were analyzed on a LSR-Fortessa™ (BD Biosciences) with conserved settings throughout the entire study and data were analyzed using FlowJo™ Software (Tree Star v10.4).
| Study group | Role | What they receive |
|---|---|---|
| Group "RA patients" | Patients with Rheumatoid Arthritis (RA) fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria. Receives: Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples | |
| Group "PsA patients" | Patients with Psoriatic Arthritis (PsA) fulfilling the Classification for PsA (CASPAR) criteria. Receives: Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples | |
| Group "Healthy donors" | Anonymous healthy donors from the Etablissement Français du Sang. Receives: Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD73 expression on T helper lymphocyte subpopulations
Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.
Measured: At inclusion
CD73 expression on T helper lymphocyte subpopulations
Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.
Measured: 3 months
CD73 expression on T helper lymphocyte subpopulations
Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953378
- Sponsor's protocol ID
- LAdoRIC
- Acronym
- LAdoRIC
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presence and Impact of CD73+ Th1.17 and of the CD39/CD73/Adenosine Cascade in Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA)
- ClinicalTrials.gov ID
- NCT03953378
- Acronym / sponsor ID
- LAdoRIC / LAdoRIC
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 May 2019 (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.
Prospective study to investigate the correlation between CD39/CD73 expression by the different T lymphocyte subpopulations in the blood and synovial fluid (if available) into patients with chronic inflammatory rheumatism RA and PsA types, with the rheumatic activity, the background therapy (with Methotrexate (MTX)) and the response to this treatment.
Detailed description
Th1.17 compose a recently described subset of highly polyfunctional and thus potentially more harmful CD4+ effector T cells (Teff) than classical Th17 as they co-produce interferon-γ (IFN-γ) and interleukin-17A (IL-17A). For this reason, Th1.17 rise increasing interest in RA and PsA since they seem involved in their pathophysiology. Hyper activation of Teff in RA and PsA results partly from a deficiency in regulatory mechanisms of Teff's pro-inflammatory functions. The ecto-nucleotidase CD73 delineates Teff enriched in Th1.17 features and acts as a regulatory mechanism for these pro-inflammatory cells. Considering that MTX, usually used as first line treatment of RA and PsA, increases extracellular concentrations of adenosine monophasphate (AMP) and immunosuppressive adenosine, the investigators hypothesized that CD4+CD73+ T cell effector population enriched in Th1.17 and Th17 cells may participate in the pathogenicity of RA and PsA but also in the resistance to MTX treatment through the specific expression of CD73 essential for Ado generation and which is down-regulated on proliferating T cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group "RA patients" | – | Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samplesPatients with Rheumatoid Arthritis (RA) fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria. |
| Group "PsA patients" | – | Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samplesPatients with Psoriatic Arthritis (PsA) fulfilling the Classification for PsA (CASPAR) criteria. |
| Group "Healthy donors" | – | Other: Multi-parametric Flow Cytometry analysis on patients and healthy donors samplesAnonymous healthy donors from the Etablissement Français du Sang. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic inflammatory rheumatism RA and PsA types with or without background therapy at the inclsuion
Key inclusion criteria (4 listed)
- Patients aged ≥ 18 years
- Patients naive to biologics
- Patients with RA fulfilling the American College of Rheumatology and European League Against Rheumatism 2009 criteria
- Patients with PsA fulfilling the Classification for PsA (CASPAR) criteria
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Multi-parametric Flow Cytometry analysis on patients and healthy donors samplesCollection of venous blood (16 mL) and synovial fluid (when available) samples, for each patient, at inclusion and in the frame of the usual medical follow-up at 3 months and between 6 and 12 months, before the onset of MTX (untreated patients) or during the course of MTX treatment (MTX-treated patients). Collection of anonymous healthy donors blood samples, age- and sex-matched, obtained from the Etablissement Français du Sang. Multi-parametric Flow Cytometry analysis was performed on these samples to assess CD73 expression on total memory T cells and within T helper lymphocyte subsets, their cytokine production and AMPase functions. For FoxP3 intracellular staining, cells were treated using the FoxP3 Fixation and Permeabilization kit (Life Technologies), according to manufacturer instructions. Stainings were analyzed on a LSR-Fortessa™ (BD Biosciences) with conserved settings throughout the entire study and data were analyzed using FlowJo™ Software (Tree Star v10.4). | Other | Group "Healthy donors", Group "PsA patients", Group "RA patients" |
Primary outcome
CD73 expression on T helper lymphocyte subpopulations
Time frame: At inclusion
Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.
CD73 expression on T helper lymphocyte subpopulations
Time frame: 3 months
Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.
CD73 expression on T helper lymphocyte subpopulations
Time frame: 12 months
Determine CD73 expression on T helper lymphocyte subpopulations (using multi-parametric Flow Cytometry), in the blood and synovial fluid of Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) patients before or under MTX treatment.
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 16 May 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Psoriatic Arthritis, run by Hospices Civils de Lyon at 1 site in France.
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 1 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 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
CD73 expression on T helper lymphocyte subpopulations (time frame: At inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2019.