Health Condition 1: null- Remitting Multiple Sclerosis and open after treatment with Interferon β1а.
Conditions
Interventions
Intervention1: Interferon β1а 30 µg per 0.5 ml: Intramuscular Injection Once a week. Each 0.5 ml solution Contains
Interferon β1а 30 µg
Duration off therapy is 104 weeks
Control Intervention1:
Sponsors
RCI Syntez Russia
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Male and female patients at the age from 18 to 55 years inclusively 3. Patients of both genders definite diagnosed with remitting multiple sclerosis (as per MacDonald criteria, 2010); 4. MS duration is more than 1 year to the moment of screening 5. 12 months before randomization (visit â??Day 1) the presence of: At least, 1 relapse or At least, 1 gadolinium enhanced T1-weighed MRI lesion 6. The patient should have neurological stable condition (without relapses) for 4 weeks before randomization (visit â??Day 1â??); 7. Readiness of patients of both genders and their partners with preserved reproductive function to use reliable methods of contraception, starting from screening day and to 4 weeks after last dose of the drug. The given requirement is not referred to patient undergone operative sterilization. Reliable methods of contraception presuppose using 1 barrier method in combination with one of the following: spermicides, intrauterine device/oral contraceptives; 5. Total score is 0-5.5 inclusively as per EDSS.
Exclusion criteria
Exclusion criteria: 1. Secondary progressive multiple sclerosis and primary progressive multiple sclerosis; 2. Other diseases (excluding multiple sclerosis) that can influence assessment of underlying disease symptoms severity: to mask, exacerbate, change the symptoms of underlying disease or to cause clinical manifestations and changes in laboratory-instrumental methods of investigation, similar to multiple sclerosis; 3. Any acute or chronic active infections; 4. Diagnosed HIV-infection, hepatitis B, C, syphilis; 5. Metabolic abnormalities manifested as: a. Increased total creatinine level for more than 2 times compared to ULN; b. Increased transaminase level (ALT, AST) or GGT for more than 2.5 times compared to ULN; 6. Abnormal bone marrow function manifested in reduced WBC count 7. EDSS score > 5.5; 8. Major depressive disorders, suicidal ideations, or attempted suicides in the history; 9. Hypo- or hyperthyroidism 10. Decompensated liver disease 11. Congestive cardiac failure or uncontrolled cardiac angina or arrhythmia; 12. Uncontrollable epilepsy 13. Pregnancy, breastfeeding or planned pregnancy for the period of the whole study; 14. History of treatment by the drug that alter multiple sclerosis progression: interferon beta-1а, interferon beta-1b, glatiramer acetate, azathioprine, immunomodulators and corticosteroids (excluding corticosteroids to treat relapses), as well as monoclonal antibodies drugs, cytotoxic and/or immunosuppressive drugs, but not limited to: Mitoxantron, Cyclophosphamide, Cyclosporine, Fingolimod, Cladribin; or total irradiation of lymphatic system 15. Systemic (iv., oral) administration of corticosteroids for 30 days before inclusion into the study (prior to randomization) 16. Hypersensitivity or allergy to IFN-β1a or other components of the drugs Interferon β1a or Avonex 17. Hypersensitivity or contraindications to administration of paracetamol or NSAIDs 18. History of drug abuse, alcohol abuse and drug misuse 19. Contraindications to MRI screening (allergy to gadolinium or claustrophobia; any renal disorder, which can interfere with gadolinium excretion â?? acute or chronic renal failure, other contraindications to the administration of contrast agent); 20. Any malignancies, including in history; 21. Vaccination for the period of 4 weeks before inclusion into the study (before randomization); 22. Participation in other clinical study for 30 days before screening or simultaneous participation in other clinical studies; 23. Previous participation in the same study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CUA- a number of new gadolinium-enhanced T1-weighed MRI lesions and new T2-weighed lesions 2. A number of BI- and NA- positive patientsTimepoint: 1. CUA- a number of new gadolinium-enhanced T1-weighed MRI lesions and new T2-weighed lesions 2. A number of BI- and NA- positive patients | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Dynamics on EDSS and MSFC Potential for sustained progression development (Persistent progression is defined as elevated score as per Expanded Disability Status Score compared to the score to the moment of screening by 1.0 in patients with 5,5 at screening or at least by 0.5 in patients with 5.5 at screeningTimepoint: After 6 months of Screening;a. Parameters related to relapses 1. Annualized relapse rate 2. Part of patients without documented relapses 3. Time to first relapse, risk of relapse development. Timepoint: A number of documented relapses every year;Immunogenicity assessment a. In 3 groups (No 1 â?? Interferon-β1а / no 2 â?? Avonex / no 3 â?? placebo)Timepoint: After 49 weeks of the blinded IFN-β1а in full dose (30µg)) or placebo (after 16 weeks) in full dose (0.5 ml);Immunogenicity assessment: In 2 groups (No 1 and No 2) after therapy terminationTimepoint: On study weeks 68, 80 and 104 i.e., after therapy termination and transferring to open-label Interferon-β1а treatment.;Immunogenicity assessment: In group No 3 (placebo)Timepoint: On weeks 44, 56, 68, 80 and 104.;Progression on MSFC Timepoint: As compared to baseline | — |
Countries
India, Russian Federation
Contacts
Public ContactMangesh Khadakban
Nexus Clinical Research (India) Ltd.
Outcome results
None listed