Relapsing-remitting multiple sclerosis (RRMS) MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Ability of the participant to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations. • Diagnosis of relapsing remitting multiple sclerosis (RRMS) according to the McDonald criteria [Thompson 2018]. • Treatment with natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing for a minimum of 12 months prior to randomization. The participant must have received at least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization. • Expanded Disability Status Scale (EDSS) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Primary and secondary progressive multiple sclerosis (MS). • MRI positive for Gd-enhancing lesions at screening. • Participants for whom MRI is contraindicated (e.g., have a contraindicated pacemaker or other contraindicated implanted metal device, have suffered, or are at risk for, side effects from Gd, or have claustrophobia that cannot be medically managed). • History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study, in the opinion of the Investigator. • Presence of anti-natalizumab antibodies at screening. NOTE: Other protocol-defined exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of natalizumab extended interval dosing (EID) in subjects who have previously been treated with natalizumab standard interval dosing (SID) for at least 12 months, in relation to continued SID treatment.;Secondary Objective: The secondary objectives are to evaluate additional clinical and MRI based efficacy endpoints, and safety of EID in subjects who have previously been treated with natalizumab SID for at least 12 months, in relation to continued SID treatment.;Primary end point(s): Number of New or Newly Enlarging T2 Hyperintense Lesions at Week 72;Timepoint(s) of evaluation of this end point: Week 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Time to First Relapse as Adjudicated by an Independent Neurology Evaluation Committee (INEC) •Number of new Gadolinium (Gd) Enhancing and new T1 Hypointense Lesions at Weeks 24, 48 and 72 •Annualized Relapse Rate at Week 72 •Number of New or Newly Enlarging T2 Hyperintense Lesions at Weeks 24 and 48 •Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) •Time to Expanded Disability Status Scale (EDSS) worsening;Timepoint(s) of evaluation of this end point: Variable time frames throughout the study | — |
Countries
Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, New Zealand, Spain, United Kingdom, United States
Outcome results
None listed