Health Condition 1: null- Patients with Multiple Sclerosis
Conditions
Interventions
Intervention1: R-TPR-011 (Interferon Beta): Dose: 30 microgram, Frequency: once in a week, Route of Administration: Intramuscularly, Duration: 52 weeks.
Control Intervention1: Not Applicable: Not Appl
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of relapsing remitting multiple sclerosis based upon McDonald criteria at the time of entry Subject having atleast 2 exacerbations in the 2 years prior to but stable for atleast 4 weeks before study entry Subject with EDSS Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures/documented to be postmenopausal 1. Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirement 2. Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent. However, when the subject is stable and is able to give consent, consent would be obtained on a separate ICF to confirm his/her willingness to continue in the study.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of primary and/or secondary progressive MS. • (Primary progressive MS: Patients that develop a sustained deterioration of their neurological function from the beginning, • Secondary progressive MS: Patients with relapsing remitting MS eventually develop sustained deterioration with or without relapses superimposed). 2. Patients with h/o and/or current severe depression and/or suicidal ideation. 3. Patients on steroids for treatment of MS within preceding 4 weeks. 4. History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; and/or other medical conditions that would preclude therapy with interferon beta. 5. Patients with Serum creatinine 1.5 x ULN. 6. History of severe allergic and/or anaphylactic reactions and/or history of hypersensitivity to human albumin 7. History of seizures within the 3 months prior to starting this study. 8. History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs that would preclude use of atleast one of these during the study. 9. History of intolerance and/or hypersensitivity to interferons and/or to any of the excipients. 10. Previous use of interferon beta within 1 week prior to enrolment. 11. Subjects positive for HIV, HBsAg or HCV. 12. Subject participation in another clinical trial 30 days prior to administration of IP. 13. Pregnant and lactating females. 14. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the number of new gadolinium enhancing lesions by serial MRI of the brain during the treatment period.Timepoint: 26 weeks of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safetyTimepoint: Evaluation of safety will be based on â?¢ Number of persistent enhancing lesions (enhancing lesions that were present on the previous scan) from baseline to week 26 â?¢ Change in lesion volume from baseline to week 26 | — |
Countries
India
Contacts
Public ContactDr Parvez Kosgi
Reliance Life Sciences Pvt. Ltd.
Outcome results
None listed