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NCT03689972 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 585
- Enrollment target
NCT03689972 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 585 participants.
The verdict
NCT03689972, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 585 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Natalizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 585 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03689972
The ClinicalTrials.gov registry entry for NCT03689972 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 585 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Natalizumab is the first listed.
NCT03689972 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03689972 about?
NCT03689972 is a clinical study titled "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". 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 Q4...
What is the current status of trial NCT03689972?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 585 participants. The study started on 2018-11-27. Estimated completion is 2023-07-24.
What interventions are being tested in trial NCT03689972?
The interventions under investigation include: Natalizumab (DRUG).
Who is sponsoring clinical trial NCT03689972?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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