Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
Intervention 1: Rebif Ampule, 12MIU, 3 times a week (Saturday,Monday,Wednesday), for 24 months. Intervention 2: Recigen Ampule, 12MIU, 3 times a week (Saturday,Monday,Wednesday), for 24 months.
Treatment - Drugs
Rebif Ampule, 12MIU, 3 times a week (Saturday,Monday,Wednesday), for 24 months
Recigen Ampule, 12MIU, 3 times a week (Saturday,Monday,Wednesday), for 24 months
Sponsors
Cinnagen Pharmaceutical
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: -Inclusion Criteria: 1.Relapsing-Remitting MS patients based on McDonald's Criteria 2.ages between 18-50 3.EDSS=<5.5 4.Signing informed consent form -Inclusion Criteria: 1.Pregnancy during trial or intention to get pregnant in start of trial 2.Psychiatric disease or major depression 3.Past history of Suicide 4.Allergy/hypersensitivity reaction to medication 5.IVIG treatment within 6 months prior to trial 6.Plasma Exchange within 6 months prior to trial 7.Cytotoxic Medication use during study 8.Impaired Liver Function Tests (3times Nl range) 9.Leukopenia (less than half the Nl range) 10.failure to follow-up for more than 4 weeks (with recording the reason)
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse Rate. Timepoint: every month. Method of measurement: Physical examination done by neurologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| EDSS. Timepoint: Every month. Method of measurement: Physical Examination done by Neurologist.;Number/size of plaques and their enhancement. Timepoint: Every 6 months. Method of measurement: MRI.;Neutralizing Antibodies. Timepoint: Every 6 months. Method of measurement: measurment in peripheral blood (NU/ml). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Shiva Salami
Cinnagen Pharmaceutical
Outcome results
None listed