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|ClinicalTrials.gov Identifier: NCT03974997|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Diagnostic Test: Determination of the circulating serum concentration of cytoquine TWEAK||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a single-center interventional study with minimal risks and constraints on a cohort of MS patients. Patients with clinically isolated syndrome suggestive of MS will be included prospectively and consecutively.|
|Masking:||None (Open Label)|
|Official Title:||TNF-related Weak Inducer of Apoptosis (TWEAK), a New Biomarker Predicting Inflammatory Thrust in Multiple Sclerosis|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||September 1, 2021|
serum concentration changes in cytokine TWEAK
We will perform a prospective study in which 50 patients with multiple sclerosis in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium).
Diagnostic Test: Determination of the circulating serum concentration of cytoquine TWEAK
Blood samples (20 ml of blood on dry tube) by venipuncture at the bend of the elbow will be made at T0, then monthly for a period of 1 year . The sera will be isolated by centrifugation and then frozen at -80 degrees Assays of the soluble form of TWEAK and TNF will be performed by ELISA blot technique developed by the team.
- The serum concentration of soluble TWEAK [ Time Frame: 1 year ]We will then compare the soluble TWEAK concentrations observed in patients with anti-TWEAK antibodies and in patients without anti-TWEAK antibodies. We will study the correlation between the concentrations of soluble TWEAK and those of soluble TNF.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974997
|Contact: Sophie DESPLAT-JEGO||+ 33 4 91 38 39 email@example.com|
|Assistance Publique Hopitaux de Marseille||Not yet recruiting|
|Marseille, France, 13354|
|Contact: Sophie DESPLAT-JEGO, IP 04 91 38 39 07 firstname.lastname@example.org|
|Contact: Kahena AMICHI 04 91 38 19 66 email@example.com|
|Study Director:||Jean-Olivier ARNAUD||Assistance Publique des Hôpitaux de Marseille|