Rheumatoid ArthritisJAK-INH2NCT03755297
Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
A study of Rheumatoid Arthritis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rheumatoid Arthritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2019to 12 Nov 2022
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General criteria
- Patient, of 18 and more years old
- Subject affiliated to a social security system
- Subject not being in period of exclusion with regard to another protocol
- Absence of pregnancy in the inclusion (date of the last period, use of a contraceptive method, ß -HCG impulsive person in case of doubt)
- Informed consent
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- Criteria of inclusion of the group rheumatoid arthritis (in vitro studies):
- Rheumatoid arthritis, corresponding to the the classification ACR / EULAR 2010 criteria
- Criteria of inclusion of the group arthritis (in vitro studies):
- Spinal degenerative osteoarthritis or degenerative osteoarthritis of the members, according to the clinical and radiological elements.
- Criteria of inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :
- Rheumatoid Polyarthritis, corresponding to the classification ACR / EULAR 2010 criteria
- Patient to whom a treatment by inhibitor of the way JAK / STAT was proposed in current care of rheumatoid arthritis.
Who cannot join
- General criteria
- Corticosteroid therapy superior to 10 mg / j
- Drip of corticoids in the previous month
- Pregnant or breast-feeding Patients
- Patient under protection(saving) of justice
- Under guardianship Patient or guardianship
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- Current Infection
- Criteria of non-inclusion of the group rheumatoid polyarthritis ( in vitro studies):
- Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab) in the previous year
- Criteria of non-inclusion of the group arthritis ( in vitro studies):
- History of autoimmune disease or néoplasie
- Treatment by immunomodulateur or biotherapics (anti-TNF alpha, tocilizumab, abatacept or rituximab)
- Criteria of non-inclusion of the group rheumatoid arthritis, longitudinal study at the patients treated by JAK / STAT inhibitors :
- Treatment by rituximab in the previous year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments.
Read the detailed description
This study will first analyze the effect of inhibitors of the JAK / STAT pathway in vitro on B-cell phenotypes and functions in 30 RA patients and 30 patients with osteoarthritis. It will also study the phenotypes and functions of B cells in RA patients for whom JAK / STAT inhibitor treatment has been prescribed by the patient's usual rheumatologist. The analysis will be done before the start of treatment and 3 months later. The phenotypes of B-cells will be assessed by flow cytometry with intra- and extra-cellular stainings. The functions of B cells will be assessed by their ability to differenciate naïve T cells in coculture.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Blood sample analysis of patients treated as standard care
- Keywords
- Rheumatoid arthritis, Regulatory B cells, JAK/STAT inhibitors
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample analysis of patients treated as standard careOther
Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Other | Patients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care Receives: Other: Blood sample analysis of patients treated as standard care |
| Osteoarthritis | Other | Control patients and Blood sample analysis of patients treated as standard care Receives: Other: Blood sample analysis of patients treated as standard care |
| Rheumatoid arthritis with JAK/STAT inhibitors | Other | Standard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care Receives: Other: Blood sample analysis of patients treated as standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of regulatory B cells induced by JAKi in vitro
IL-10+ CD19+ cells after in vitro exposure of JAKi
Measured: 4 months
Secondary outcomes (2)
Percentage of regulatory T cells induced by JAKi treated B cells in vitro
CD25hiCD126lo/-CD4+ after 3 days of coculture with JAKi pretreated B cells
Measured: 4 months
Percentage of Th1 induced by JAKi treated B cells in vitro
Interferon gamma+CD4+ after 3 days of coculture with JAKi pretreated B cells
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start12 Feb 2019
- Primary completion12 Aug 2022
- Study completion12 Nov 2022
Why it stopped: Default of recruitment
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 University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Pfizer
- Responsible party
- Sponsor
- Investigators
- Claire DAIEN, PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755297
- Sponsor's protocol ID
- RECHMPL17_0393
- Other IDs
- 2017-A03095-48
- Acronym
- JAK-INH2
- Status last verified
- Sep 2023
- First submitted
- 26 Nov 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03755297
- Acronym / sponsor ID
- JAK-INH2 / RECHMPL17_0393
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, Regulatory B cells, JAK/STAT inhibitors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Default of recruitment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Pfizer
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Nov 2022 (actual)
- First posted
- 27 Nov 2018 (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.
This study will investigate whether inhibitors of the JAK / STAT signaling pathway can increase anti-inflammatory functions of B cells in patients with RA using in vitro and in vivo experiments.
Detailed description
This study will first analyze the effect of inhibitors of the JAK / STAT pathway in vitro on B-cell phenotypes and functions in 30 RA patients and 30 patients with osteoarthritis. It will also study the phenotypes and functions of B cells in RA patients for whom JAK / STAT inhibitor treatment has been prescribed by the patient's usual rheumatologist. The analysis will be done before the start of treatment and 3 months later. The phenotypes of B-cells will be assessed by flow cytometry with intra- and extra-cellular stainings. The functions of B cells will be assessed by their ability to differenciate naïve T cells in coculture.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | Other | Other: Blood sample analysis of patients treated as standard carePatients responding to ACR/EULAR 2010 criteria and Blood sample analysis of patients treated as standard care |
| Osteoarthritis | Other | Other: Blood sample analysis of patients treated as standard careControl patients and Blood sample analysis of patients treated as standard care |
| Rheumatoid arthritis with JAK/STAT inhibitors | Other | Other: Blood sample analysis of patients treated as standard careStandard use of JAK/STAT inhibitors and Blood sample analysis of patients treated as standard care |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- General criteria
- Patient, of 18 and more years old
- Subject affiliated to a social security system
- Subject not being in period of exclusion with regard to another protocol
- Absence of pregnancy in the inclusion (date of the last period, use of a contraceptive method, ß -HCG impulsive person in case of doubt)
Key exclusion criteria (14 listed)
- General criteria
- Corticosteroid therapy superior to 10 mg / j
- Drip of corticoids in the previous month
- Pregnant or breast-feeding Patients
- Patient under protection(saving) of justice
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 |
|---|---|---|
| Blood sample analysis of patients treated as standard careBlood sample to analyse percentage of blood cells (regulatory B cells et T cells) | Other | Osteoarthritis, Rheumatoid arthritis, Rheumatoid arthritis with JAK/STAT inhibitors |
Primary outcome
Percentage of regulatory B cells induced by JAKi in vitro
Time frame: 4 months
IL-10+ CD19+ cells after in vitro exposure of JAKi
2 secondary outcomes
Percentage of regulatory T cells induced by JAKi treated B cells in vitro
Time frame: 4 months
Percentage of Th1 induced by JAKi treated B cells in vitro
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Default of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Claire DAIEN, PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Rheumatoid Arthritis, run by University Hospital, Montpellier 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 13 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Sep 2025. 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 was stopped early (reason given: Default of recruitment). Results are not available in the source record.
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?
Percentage of regulatory B cells induced by JAKi in vitro (time frame: 4 months). 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 30 Sep 2025.