A clinical trial to study the effects of two drugs, Relibeta and Avonex in the treatment of patients with remitting multiple sclerosis and open after treatment with Interferon β1а.

Phase 3

• Conditions: Health Condition 1: null- Remitting Multiple Sclerosis and open after treatment with Interferon β1а.

• Registration Number: CTRI/2015/08/006093
• Lead Sponsor: RCI Syntez Russia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 280

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

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 <3.0 Ñ? 109/L, or platelets <125 Ñ? 109/L, or reduced hemoglobin count <100 g/L;

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

Study & Design

• Study Type: Observational
• Study Design: Not specified