Multiple sclerosis therapy with transdermal myelin peptide stimulation.

INTERVENTION: Product Name: SMderpept Pharmaceutical Form: Powder for cutaneous solution INN or Proposed INN: PLP peptide Current Sponsor code: PLP peptide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ INN or Proposed INN: MBP peptide Current Sponsor code: MBP peptide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ INN or Proposed INN: MOG peptide Current Sponsor code: MOG peptide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Product Name: SMderpept Pharmaceutical Form: Powder for cutaneous solution INN or Proposed INN: PLP peptide Current Sponsor code: PLP peptide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ INN or Proposed INN: MBP peptide Current Sponsor code: MBP peptide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ INN or Proposed INN: MOG peptide Current Sponsor code: MOG peptide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Product Name: Avonex Pharmaceutical Form: Solution for injection INN or Proposed INN: Interferon beta 1‐A CAS Number: 220581‐49‐7 Other descriptive name: INTERFERON BETA‐1A Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 30‐ CONDITION: relapsing‐remitting multiple sclerosis Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: The demonstration that myelin MBP85‐99, MOG 35‐55 PLP139‐151 peptide mixture reduces the amount of relapses as compared to treatment with interferon beta 1A.; ; Primary end point(s): The demonstration that myelin MBP85‐99, MOG 35‐55 PLP139‐151 peptide mixture reduces the amount of relapses as compared to treatment with interferon beta 1A.; ; Secondary Objective: Secondary objectives :; ‐ cumulative number of gadolinium positive changes in MRI; ‐ new / enlarging changes in the MRI T2 sequence ; ‐ number of new changes in the MRI T1 sequence ; ‐ change in MTR factor; Timepoint(s) of evaluation of this end point: every patient visit SECONDARY OUTCOME: Secondary end point(s): ‐ cumulative number of gadolinium positive changes in MRI; ‐ new / enlarging changes in the MRI T2 sequence ; ‐ number of new changes in the MRI T1 sequence ; ‐ change in MTR factor; Timepoint(s) of evaluation of this end point: 12,24,36,48,60,72,84,96 week INCLUSION CRITERIA: The signing of informed consent to participate in the study Women and men aged 18‐60 years RR diagnosis of MS according to the McDonald criteria 2010 State disability by EDSS 0 to 5.5 At least one relapse in the 12 months prior to screening Neurologically stable during the 30 days prior to screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range