Systemic SclerosisSCLERO JAKNCT04206644
Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages
An observational study of Systemic Sclerosis, run by Rennes University Hospital at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- biological analysis
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2021to 13 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- Adult
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
Who may be able to join
- 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
Who cannot join
- patients unable to consent
- patients with anemia inferior to 7g/dL
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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 :
- 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)
- Conditions
- Systemic Sclerosis
- Being tested
- biological analysis
- Keywords
- Systemic sclerosis, macrophage, ruxolitinib
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological analysisOther
biological analysis of the Concentration of CCL18
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis patients | SSc patients according to the ACR/EULAR 2013 classification criteria Receives: Other: biological analysis | |
| Healthy donors | HD healthy donors from EFS (Etablissement Français du sang) Receives: Other: biological analysis | |
| LUPUS Patiets | Lupus patients according to the ACR 2019 classification criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of CCL18 in the condition media of MDM from SSc patients
at the end of the study
Measured: through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start21 Jan 2021
- Primary completion13 Jan 2023
- Study completion13 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick JEGO, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206644
- Sponsor's protocol ID
- 35RC19_30043_SCLERO JAK
- Acronym
- SCLERO JAK
- Status last verified
- Apr 2023
- First submitted
- 18 Dec 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Sclerosis and Jak Inhibitors : Emphasis on Macrophages
- ClinicalTrials.gov ID
- NCT04206644
- Acronym / sponsor ID
- SCLERO JAK / 35RC19_30043_SCLERO JAK
- Conditions
- Systemic Sclerosis
- Keywords
- Systemic sclerosis, macrophage, ruxolitinib
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Feb 2027 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 :
- 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)
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis patients | – | Other: biological analysisSSc patients according to the ACR/EULAR 2013 classification criteria |
| Healthy donors | – | Other: biological analysisHD healthy donors from EFS (Etablissement Français du sang) |
| LUPUS Patiets | – | –Lupus patients according to the ACR 2019 classification criteria |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- patients unable to consent
- patients with anemia inferior to 7g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological analysisbiological analysis of the Concentration of CCL18 | Other | Healthy donors, Systemic sclerosis patients |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick JEGO principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of CCL18 in the condition media of MDM from SSc patients (time frame: through study completion, an average of 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.