A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab Administration
Completed · Phase 3
Conditions studied: Multiple Sclerosis, Relapsing-Remitting
In brief
Part 1: The primary objective is to evaluate the efficacy of natalizumab extended interval dosing (EID) (every 6 weeks \[Q6W\]) in participants who have previously been treated with natalizumab standard interval dosing (SID) (every 4 weeks \[Q4W\]) for at least 12 months, in relation to continued Q4W treatment. The secondary objectives is to evaluate relapse-based clinical efficacy measures, disability worsening, additional Magnetic resonance imaging (MRI)-lesion efficacy measures and safety of Q6W in participants who have previously been treated with natalizumab Q4W for at least 12 months, in relation to continued Q4W treatment. Part 2: The primary objective is to evaluate participant preference for subcutaneous (SC) versus intravenous (IV) route of natalizumab administration. The secondary objectives is to evaluate treatment satisfaction, drug preparation and administration time, safety and immunogenicity, efficacy and characterize pharmacokinetic (PK) and pharmacodynamic (PD) drug preparation and administration time of SC versus IV routes of natalizumab administration.
Key facts
- Study ID
- NCT03689972
- Run by
- Biogen
- People needed
- 585
- Starts
- 2018-11-27
- Expected to finish
- 2023-07-24
- Last updated by the study team
- 2024-06-12
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Alabama Neurology Associates — Homewood, Alabama, United States
- UCI MIND — Irvine, California, United States
- UC San Diego Movement Disorder Center — La Jolla, California, United States
- MS Center of California — Laguna Hills, California, United States
- Stanford Hospital and Clinics — Palo Alto, California, United States
- University of Colorado Hospital Anschutz Outpatient Pavillion — Aurora, Colorado, United States
- Advanced Neurosciences Research — Fort Collins, Colorado, United States
- Yale University — Fairfield, Connecticut, United States
- Georgetown University Hospital-Medstar — Washington D.C., District of Columbia, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Infinity Clinical Research, LLC — Sunrise, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Shepherd Center, Inc. — Atlanta, Georgia, United States
- Atlanta Neuroscience Institute — Atlanta, Georgia, United States
- NorthShore University HealthSystem — Evanston, Illinois, United States
- Northwestern University — Evanston, Illinois, United States
- College Park Family Care Center — Overland Park, Kansas, United States
- Lahey Clinic Inc. - PARENT ACCOUNT — Burlington, Massachusetts, United States
- Neurology Center of New England P.C. — Foxborough, Massachusetts, United States
- Beth Israel Deaconess Medical Center, Inc. — Jamaica Plain, Massachusetts, United States
- Dragonfly Research, LLC — Wellesley, Massachusetts, United States
- South Shore Neurology Associates — Weymouth, Massachusetts, United States
- Michigan Institute for Neurological Disorders — Farmington Hills, Michigan, United States
- Michigan State University — Grand Rapids, Michigan, United States
- North Central Neurology Associates, P.C. — Cullman, Alabama, United States
Full record on ClinicalTrials.gov
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