Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis | Diagnostic Test: Determination of the circulating serum concentration of cytoquine TWEAK | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
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) |
Primary Purpose: | Other |
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 |
Arm | Intervention/treatment |
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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).
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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.
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sophie DESPLAT-JEGO | + 33 4 91 38 39 07 | sophie.jego-desplat@ap-hm.fr |
France | |
Assistance Publique Hopitaux de Marseille | |
Marseille, France, 13354 | |
Contact: Sophie DESPLAT-JEGO, IP 04 91 38 39 07 sophie.jego-desplat@ap-hm.fr | |
Contact: Kahena AMICHI 04 91 38 19 66 promotion.interne@ap-hm.fr |
Study Director: | Jean-Olivier ARNAUD | Assistance Publique des Hôpitaux de Marseille |
Tracking Information | |||||
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First Submitted Date ICMJE | June 3, 2019 | ||||
First Posted Date ICMJE | June 5, 2019 | ||||
Last Update Posted Date | June 5, 2019 | ||||
Estimated Study Start Date ICMJE | September 1, 2019 | ||||
Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Multiple Sclerosis | ||||
Official Title ICMJE | TNF-related Weak Inducer of Apoptosis (TWEAK), a New Biomarker Predicting Inflammatory Thrust in Multiple Sclerosis | ||||
Brief Summary | A significant variation in the serum concentration of the circulating cytokine TWEAK is associated with the onset of an inflammatory attack of MS. Study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak. | ||||
Detailed Description | Multiple sclerosis (MS) is the most common chronic autoimmune demyelinating and neurodegenerative disease of the central nervous system (CNS) of disabling neurological diseases in young adults in France. Patients with MS can present a wide range of symptoms spread over time and space such as motor, sensory, visual or vesico-sphincter deficits. One of the current challenges in treating patients with symptoms suggestive of MS is to assess the risk of an inflammatory flare in order to avoid or limit the installation of an irreversible neurological handicap. At present, the inflammatory activity of the disease is evaluable only by cerebral imaging (MRI). However, these examinations can not be carried out as often as necessary because of their accessibility, cost, duration and the potential deleterious effects of gadolinium accumulation. This is why a blood biomarker able to report early on the inflammatory activity of the disease would be of great help during the monitoring and treatment of patients. TWEAK (TNF-related weak inducer of apoptosis or TNFSF12) is a pro-inflammatory cytokine member of the TNF family. This cytokine is overexpressed in tissues with chronic inflammatory diseases such as MS. It is produced by monocytes / macrophages and microglial cells and can exist in soluble or membrane form.the investigators of our clinical department were the first to describe the pro-inflammatory role of TWEAK in MS. Indeed, we have demonstrated in an animal model of MS that the inhibition of TWEAK makes it possible to reduce the severity of the disease. Our recent work (manuscript submitted for publication) has also shown results from a series of 28 patients with MS suggesting that the serum TWEAK assay may be an early marker of thrust occurrence. the investigators propose to study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak. the investigators will perform a prospective study in which 50 patients with MS 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). | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A 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)Primary Purpose: Other |
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Condition ICMJE | Multiple Sclerosis | ||||
Intervention ICMJE | 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.
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Study Arms ICMJE | 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).
Intervention: Diagnostic Test: Determination of the circulating serum concentration of cytoquine TWEAK
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 1, 2021 | ||||
Estimated Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03974997 | ||||
Other Study ID Numbers ICMJE | 2019-12 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Assistance Publique Hopitaux De Marseille | ||||
Study Sponsor ICMJE | Assistance Publique Hopitaux De Marseille | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Assistance Publique Hopitaux De Marseille | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |