Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants

Phase 3

• Conditions: Health Condition 1: G35- Multiple sclerosis

• Registration Number: CTRI/2021/12/038986
• Lead Sponsor: Biogen MA Inc Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1 Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS

2 Must have an EDSS score between 0.0 and 5.0.

3 Must have a body weight of �30 kg

4 Must have experienced �1 relapse in the 12 months prior to randomization (Day 1) or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or �2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event

Exclusion Criteria

1 Participants having primary progressive, secondary progressive, or progressive RMS.

2 Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.

3 History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study

4 Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified