Analyze the Myelin-TRAP as Diagnostic Tool in Multiple Sclerosis (TRAP-Myéline)

Nantes University Hospital (NUH)

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Device: Trap Myelin Test

Study type: Interventional

Funder types: Other

Identifiers

NCT01723631

2010-A00892-37 (Other Identifier)

BRD/10/06-S

Details and patient eligibility

About

The objective of this project is to characterize the response TRAP positive patients with Multiple Sclerosis (MS) and to evaluate the sensitivity and specificity of the method in order to develop a second time as a diagnostic tool in this disease. We plan to analyze the response TRAP over a hundred patients with various clinical stages SEP (relapsing, progressive forms) and compared to healthy controls,

Enrollment: 189 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• These criteria depend on the subgroup belongs to the patient.
• Signed consent
• Membership of a social security system

Exclusion criteria

• Whatever the patient group or control:
• Processing immunosuppressive.
• Processing by a monoclonal antibody.
• Previous treatment with an immunosuppressant for a significant period of time (more than 6 months of oral treatment, more than 6 cycles of cyclophosphamide over 3 cures mitoxantrone).
• Carcinomatous pathology known evolving.
• People under guardianship.
• Pregnant women.
• Patients not motivated to study. Known patients with anemia (hemoglobin <10g/100ml)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 7 patient groups

Relapsing Multiple Sclerosis- group 1

Other group

Description:

Definite multiple sclerosis according to the McDonald criteria, relapsing Patient innocent of thorough treatment or treatment immunomodulator stopped for at least 6 months.

Treatment:

Device: Trap Myelin Test

Relapsing Multiple Sclerosis- group 2

Other group

Description:

Multiple sclerosis defined according to the criteria of McDonald, relapsing Patient under treatment immunomodulator for at least 6 months.

Treatment:

Device: Trap Myelin Test

secondary progressive multiple sclerosis- Group 3

Other group

Description:

Multiple sclerosis defined according to the criteria of McDonald, secondary progressive multiple sclerosis

Treatment:

Device: Trap Myelin Test

primary progressive multiple sclerosis- group 4

Other group

Description:

Multiple sclerosis defined according to the criteria of McDonald, primary progressive multiple sclerosis

Treatment:

Device: Trap Myelin Test

control 1

Other group

Description:

healthy volunteers

Treatment:

Device: Trap Myelin Test

Control 2

Other group

Description:

Patients with central or peripheral neurological non-inflammatory, non-autoimmune.

Treatment:

Device: Trap Myelin Test

Control 3

Other group

Description:

Patients having an autoimmune pathology

Treatment:

Device: Trap Myelin Test