A Study to Evaluate Efficacy, Safety, and Tolerability of EID 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 - Followed by Extension Study Comprising SC and IV Natalizumab Administratio

Phase 1

• Conditions: Relapsing-remitting multiple sclerosis (RRMS); MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-002145-11-GB
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

For Part 1:
• 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

For Part 2:
• Ability of the participants to understand the purpose and risks of the
study and provide signed and dated informed consent for Part 2 and
authorization to use confidential health information in accordance with
national and local participant privacy regulations.
• Completed Part 1 Week 72 visit while remaining on their randomized
treatment assignment of SID or EID.
• The inclusion and exclusion criteria for new participants who did not
participate in Part 1 of the study are the same as those for participants
who did participate in Part 1.

NOTE: Other protocol-defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 0

Exclusion Criteria

For Part 1:
• 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.

For Part 2:
• Participants treated with natalizumab EID was reverted to natalizumab
SID by choice or as rescue treatment in Part 1.
• Participant received treatment with any MS disease-modifying therapy
other than natalizumab in Part 1 or in the period between Part 1 and
Part 2.
• History of human immunodeficiency virus or history of other
immunodeficient conditions.
• Current enrollment or a plan to enroll in any interventional clinical
study in which an investigational treatment or approved therapy for
investigational use is administered within 30 days (or 5 half-lives of the
agent, whichever is longer) prior to the Baseline Visit or at any time
during this study.
• Inability to comply with study requirements.
• Other unspecified reasons that, in the opinion of the Investigator or
Biogen, make the participant unsuitable for enrollment.
The inclusion and exclusion criteria for new participants who did not
participate in Part 1 of the study are the same as those for participants
who did participate in Part 1.

NOTE: Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified