multiple sclerosis. Disseminated Multiple Sclerosis
Conditions
Interventions
fingolimod capsule, chemical formulation FTY -720 , (0.5 mg/ day, oral , every day) for 12 months ,made in Osvah Pharmaceutical Company in Islamic Republic Of Iran, generic name Cap. Fingolide®.
Treatment - Drugs
fingolimod capsule, chemical formulation FTY -720 , (0.5 mg/ day, oral , every day) for 12 months ,made in Osvah Pharmaceutical Company in Islamic Republic Of Iran, generic name Cap. Fingolide®
Sponsors
Vice-chancellor for research, Kermanshah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1.Patients with Relapsing- Remitting Multiple Sclerosis (RRMS) based on McDonald's Criteria (2010) 2.age between 18 to 45 years 3. EDSS between 0 to 5.5 4. at least one relapse in previous year while receiving first line disease modifying therapy 5.at least 2 relapses in previous 2 years while receiving first line disease modifying therapy 6. no relapses in 30 days previous to fingolimod initiation 7. negative pregnancy tests in child bearing women 8. positive history of varicella zoster virus vaccination or positive anti varicella zoster antibody in serum Exclusion criteria: 1. primary or secondary progressive MS 2. history of chronic systemic disease other than MS (lung, liver, kidney,...disease) 3. history of or active malignancy 4. presence of macular edema at baseline 5. acute or chronic active bacterial, viral or fungal infection 6. treatment with IV corticosteroids during 30 days previous to fingolimod initiation 7. history of treatment with cyclophosphamide or mitoxantrone at any time 8. history of treatment with immunoglobulins or monclonal antibodys in previous 6 months 9. history of treatment with methotroxate or azathioprine in previous 6 months 10. pregnancy or lactation 11. inocculation of live attenuated vaccines in previous 2 months 12. history of unstable angina, MI, TIA or CVA in previous 6 months 13. history of hospitalization due to decompensated heart failure in previous 6 months 14. Canada heart association class 3 or 4 heart failure 15. history or presence of second degree mobitz type AV block, third degree AV block or sick sinus syndrome, except having functional cardiac pace maker 16. QT interval more than 500 millisecond on baseline EKG 17. treatment with antiarythmic drugs class 1a or class 3 18. AST or ALT two folds normal upper limit 19. ALP 1.5 folds normal upper limit 20. direct or total Billi more than normal upper limit 21. creatinin more than 1.7 mg/dl 22. WBC less than 3500/ mm3 23. lymphocyte count less than 800/ mm3 24. presence of uveitis
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expanded disability score scale,EDSS. Timepoint: before intervention and every 3 months after intervention. Method of measurement: EDSS qustionair. | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual relapse rate. Timepoint: before intervention and monthly after intervention. Method of measurement: physical examination by neurologist and EDSS questionair.;Disability progression. Timepoint: before intervention and monthly after intervention. Method of measurement: one point increment in EDSS that remains for 3 months, without new relapse at the time of evaluation.;Drug side effects. Timepoint: before intervention and monthly after intervention. Method of measurement: patient reported complications and designed drug side effect questionair. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Nazanin Razazian
Kermanshah University of Medical Sciences
Outcome results
None listed