A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment
- Conditions
- Relapsing-remitting multiple sclerosis (RRMS)MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2018-002145-11-DE
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
• 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) <=5.5 at screening.
• No relapses in the last 12 months prior to randomization, as determined by the enrolling Investigator
NOTE: Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method