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

April 11, 2023 updated by: Rennes University Hospital
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 18 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patients with systemic sclerosis according to the ACR/EULAR 2013 classification criteria for systemic sclerosis

or Lupus patients according to the ACR 2019 classification criteria

or healthy donors

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Systemic sclerosis patients
SSc patients according to the ACR/EULAR 2013 classification criteria
Other: biological analysis
biological analysis of the Concentration of CCL18
Healthy donors
HD healthy donors from EFS (Etablissement Français du sang)
Other: biological analysis
biological analysis of the Concentration of CCL18
LUPUS Patiets
Lupus patients according to the ACR 2019 classification criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of CCL18 in the condition media of MDM from SSc patients
Time Frame: through study completion, an average of 4 year
at the end of the study
through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Patrick JEGO, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Actual)

January 13, 2023

Study Completion (Anticipated)

February 13, 2027

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC19_30043_SCLERO JAK

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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