TWEAK, a New Biomarker for Predicting Inflammatory Relapses in Multiple Sclerosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a first episode of inflammation and demyelination of the central nervous system affecting the optic nerve, the spinal cord, one cerebral hemisphere, or the brainstem; or confirmed multiple sclerosis

no differential diagnosis at enrollment based on clinical examination and laboratory tests

compliance with the revised 2017 Mac Donald diagnostic criteria

Disqualifiers

age <18 years old

person in an emergency situation

adult who is subject to a legal protection measure (an adult under guardianship, conservatorship, or judicial protection), or who is unable to give consent

not Enrolled in a Social Security Program

Trial design

Design model

Single group

Treatments tested in this trial

  • Determination of the circulating serum concentration of cytoquine TWEAK

    Diagnostic test

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: serum concentration changes in cytokine TWEAKOther 1 intervention

Trial outcomes

Primary outcomes

1

The serum concentration of soluble TWEAK

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.

Time frame
1 year

Secondary outcomes

1

The titers of anti-TWEAK antibodies

Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample

Time frame
1 year
2

Functional properties of anti-TWEAK antibodies

Positive or negative test Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample

Time frame
1 year
3

Soluble TWEAK concentrations

Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample

Time frame
1 year
4

Serum concentrations of soluble TNF

Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample

Time frame
1 year

Other outcomes

Sponsors and contacts

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