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
Public ClinicalTrials.gov record NCT03689972. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03689972
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 585 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2018 (Actual)
- Primary completion
- Jan 31, 2023 (Actual)
- Completion
- Jul 24, 2023 (Actual)
- Last update posted
- Jun 12, 2024
2018 – 2023
United States locations
- U.S. sites
- 52
- U.S. states
- 26
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Central Neurology Associates, P.C. | Cullman | Alabama | 35058 | — |
| Alabama Neurology Associates | Homewood | Alabama | 35209 | — |
| UCI MIND | Irvine | California | 92607 | — |
| UC San Diego Movement Disorder Center | La Jolla | California | 92037 | — |
| MS Center of California | Laguna Hills | California | 92653 | — |
| Stanford Hospital and Clinics | Palo Alto | California | 94304 | — |
| University of Colorado Hospital Anschutz Outpatient Pavillion | Aurora | Colorado | 80010-0510 | — |
| Advanced Neurosciences Research | Fort Collins | Colorado | 80528 | — |
| Yale University | Fairfield | Connecticut | 06824 | — |
| Georgetown University Hospital-Medstar | Washington D.C. | District of Columbia | 20007-2113 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33125 | — |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Shepherd Center, Inc. | Atlanta | Georgia | 30309 | — |
| Atlanta Neuroscience Institute | Atlanta | Georgia | 30327 | — |
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| College Park Family Care Center | Overland Park | Kansas | 66212 | — |
| Lahey Clinic Inc. - PARENT ACCOUNT | Burlington | Massachusetts | 01805 | — |
| Neurology Center of New England P.C. | Foxborough | Massachusetts | 02035 | — |
| Beth Israel Deaconess Medical Center, Inc. | Jamaica Plain | Massachusetts | 02130-2075 | — |
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | — |
| South Shore Neurology Associates | Weymouth | Massachusetts | 02190 | — |
| Michigan Institute for Neurological Disorders | Farmington Hills | Michigan | 48334 | — |
| Michigan State University | Grand Rapids | Michigan | 49506 | — |
| Memorial Healthcare | Owosso | Michigan | 48867 | — |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | — |
| Washington University, School of Medicine | St Louis | Missouri | 63110 | — |
| Cleveland Clinic Lou Ruvo Center for Brain Health | Las Vegas | Nevada | 89106 | — |
| RWJ Barnabas Health | Newark | New Jersey | 07102 | — |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | — |
| NYU Langone Clinical Cancer Center | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Columbia University Hervert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Island Neurological Associates, P.C. | Plainview | New York | 11803 | — |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6010 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| OhioHealth Riverside Methodist Hospital | Columbus | Ohio | 43214 | — |
| Dayton Center for Neurological Disorders | Dayton | Ohio | 45459 | — |
| Providence Neurological Specialties | Portland | Oregon | 97225 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| Sibyl Wray, MD Neurology, PC | Knoxville | Tennessee | 37922 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37215 | — |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | — |
| Rocky Mountain MS Research Group LLC | Salt Lake City | Utah | 84103 | — |
| University Of Virginia | Charlottesville | Virginia | 22908 | — |
| Multiple Sclerosis Center of Greater Washington | Vienna | Virginia | 22182 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Wheaton Franciscan Healthcare | Milwaukee | Wisconsin | 53227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03689972, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 12, 2024 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03689972 live on ClinicalTrials.gov.