Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages (SCLERO JAK)

R

Rennes University Hospital

Status

Active, not recruiting

Conditions

Systemic Sclerosis

Treatments

Other: biological analysis

Study type

Observational

Funder types

Other

Identifiers

NCT04206644
35RC19_30043_SCLERO JAK

Details and patient eligibility

About

The Sclero-JAK project aims to assess the impact of a JAK1/2 inhibitor (ruxolitinib) on activation states of monocytes-derived macrophages (MDM) from systemic sclerosis (SSc) patients

Full description

Systemic sclerosis is a fibrotic and inflammatory chronic autoimmune disorder with no disease modifiying drug available to date. JAK inhibitors may represent a relevant therapeutic candidate for this disease; The primary objective of this study is to characterize the impact of Ruxolitinib (a JAK ½ inhibitor) on the prof-fibrotic properties of MDM from SSc patients in vitro. The primary outcome will be the concentration of CCL18 evaluate by ELISA in the condition media of MDM from SSc patients pre treated or not in vitro by ruxolitinib. The secondary objectives : To characterize the impact of ruxolitinib on other pro-inflammatory or pro-fibrotic cytokines To characterize the impact of ruxolitinib on membrane expression of macrophagic polarization markers of MDM from SSc patients To evaluate the impact of ruxolitinib on the phenotype of MDM from healthy donors exposed in vitro to the serum of SSc patients. To determine the variability of the effects of ruxolitinib on MDM of SSc patients depending on key clinical characteristics (diffuse versus limited SSc, patients with or without Interstitial Lung disease ILD) The secondary outcomes : ELISA of the following cytokine evaluated in the condition media of SSc MDM pre-treated or not with ruxolitinib : PDGFbb, IL-6, CXCL10, CXCL4 Membrane expression (flow cytometry) of the following markers expressed by SSc MDM pre-treated or not with ruxoltinib : CD204, CD206, CD163, CD86, CMHII, TLR4. Evaluation of the same cytokines and membrane markers in MDM from HD exposed to serum media of SSc patients. Variation of the effect of ruxolitinib on the primary outcome (CCL18 secreted in the condition media of MDM from SSc patients) in sub groups depending on the following characteristics : Auto antibodies (anticentromere, antitopoisomerase, anti RNA polymerase III or none) modified Rodnan skin score Digital ulcers (current or past) Pulmonary involvement (Interstitial Lung disease on CT scan) Heart involvement (Pulmonary arterial hypertension on echocardiography)

Enrollment

150 patients

Sex

All

Ages

18 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients with systemic sclerosis according to the ACR/EULAR 2013 classification criteria for systemic sclerosis or Patients with systemic lupus according to the ACR2019 classification criteria for systemic lupus
  • with informed consent for participation to the study

Exclusion criteria

  • patients unable to consent
  • patients with anemia inferior to 7g/dL

Trial design

150 participants in 3 patient groups

Systemic sclerosis patients
Description:
SSc patients according to the ACR/EULAR 2013 classification criteria
Treatment:
Other: biological analysis
Healthy donors
Description:
HD healthy donors from EFS (Etablissement Français du sang)
Treatment:
Other: biological analysis
LUPUS Patiets
Description:
Lupus patients according to the ACR 2019 classification criteria

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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