NCT04206644

Brief 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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Jan 2021Feb 2027

First Submitted

Initial submission to the registry

December 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2023

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2027

Expected
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

December 18, 2019

Last Update Submit

April 11, 2023

Conditions

Systemic Sclerosis

Keywords

Systemic sclerosismacrophageruxolitinib

Outcome Measures

Primary Outcomes (1)

  • Concentration of CCL18 in the condition media of MDM from SSc patients

    at the end of the study

    through study completion, an average of 4 year

Study Arms (3)

Systemic sclerosis patients

SSc patients according to the ACR/EULAR 2013 classification criteria

Other: biological analysis

Healthy donors

HD healthy donors from EFS (Etablissement Français du sang)

Other: biological analysis

LUPUS Patiets

Lupus patients according to the ACR 2019 classification criteria

Interventions

biological analysisOTHER

biological analysis of the Concentration of CCL18

Healthy donorsSystemic sclerosis patients

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Biological Oxygen Demand Analysis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Environmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Patrick JEGO

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

December 20, 2019

Study Start

January 21, 2021

Primary Completion

January 13, 2023

Study Completion (Estimated)

February 13, 2027

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

FR(1)