Systemic Sclerosis & Jak Inhibitors : Emphasis on Macrophages

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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 : 1. To characterize the impact of ruxolitinib on other pro-inflammatory or pro-fibrotic cytokines 2. To characterize the impact of ruxolitinib on membrane expression of macrophagic polarization markers of MDM from SSc patients 3. To evaluate the impact of ruxolitinib on the phenotype of MDM from healthy donors exposed in vitro to the serum of SSc patients. 4. 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 : 1. ELISA of the following cytokine evaluated in the condition media of SSc MDM pre-treated or not with ruxolitinib : PDGFbb, IL-6, CXCL10, CXCL4 2. Membrane expression (flow cytometry) of the following markers expressed by SSc MDM pre-treated or not with ruxoltinib : CD204, CD206, CD163, CD86, CMHII, TLR4. 3. Evaluation of the same cytokines and membrane markers in MDM from HD exposed to serum media of SSc patients. 4. 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04206644
Study type	Observational
Source	Rennes University Hospital
Contact
Status	Active, not recruiting
Phase
Start date	January 21, 2021
Completion date	February 13, 2027

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages — SCLERO JAK

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms