Multiple Sclerosis. Multiple Sclerosis
Conditions
Interventions
Intervention 1: Avonex, 30, microgram, IM, weekly, for 104 weeks. Intervention 2: Cinnovex, 30 microgram, IM, weekly, for 104 weeks.
Treatment - Drugs
Avonex, 30, microgram, IM, weekly, for 104 weeks
Cinnovex, 30 microgram, IM, weekly, for 104 weeks
Sponsors
Cinnagen Company
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria:RRMS as defined by Mc Donald's criteria, Age: 18-50 years, EDSS 0-5.5, signing informed consent Exclusion Criteria: Pregnancy or the desire to become pregnant during the trial period, major depression or psychiatric problem, history of suicidal attempt, Allergy to INF-beta, IVIG during the past 6 months, Cytotoxic medications, increased liver enzymes >3 times, leucopenia, missing patient for 4 consecutive weeks, plasmapheresis.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disability. Timepoint: Monthly for 2 years, since one month after intervention. Method of measurement: Expanded disability status scale (EDSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of attacks. Timepoint: monthly for 2 years, since one month after intervention. Method of measurement: reported by the patient and detected on examination.;MRI Changes. Timepoint: Baseline and since 6 months after intervention, every 6 months for 2 years. Method of measurement: Image J software.;Neutralizing Antibodies. Timepoint: every 6 months for 2 years, since 6 months after intervention,. Method of measurement: CPE method.;Adverse events. Timepoint: monthly afterwards for 2 years, scince one week after intervention weekly for the first month. Method of measurement: checklist. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactShiva Salami
Cinnagen
Outcome results
None listed