Clinical trial NCT03755297: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells
Official title: Effect of the Inhibitors of the Way JAK-STAT on Regulatory B Cells in the Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Regulatory B cells
JAK/STAT inhibitors
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
name: Pfizer
First posted: 2018-11-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

* 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
* 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.

Exclusion criteria:

* 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
* 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

Primary outcomes:
measure: Percentage of regulatory B cells induced by JAKi in vitro
timeFrame: 4 months
Secondary outcomes:
measure: Percentage of regulatory T cells induced by JAKi treated B cells in vitro
timeFrame: 4 months
measure: Percentage of Th1 induced by JAKi treated B cells in vitro
timeFrame: 4 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Claire DAIEN, PH
role: PRINCIPAL_INVESTIGATOR
References: