The Comparison of ReciGen and Rebif in patients with Relapsing Multiple Sclerosis
Phase 3
- Conditions
- Multiple Sclerosis.Multiple sclerosis
- Registration Number
- IRCT201112201859N3
- Lead Sponsor
- Cinnagen Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relapse Rate. Timepoint: every month. Method of measurement: Physical examination done by neurologist.
- Secondary Outcome Measures
Name Time Method 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).