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NCT05925049 · ClinicalTrials.gov registry record
A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)
A clinical trial of Multiple Sclerosis, sponsored by Biogen.
- Active
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT05925049 is a study of Multiple Sclerosis that is active but no longer recruiting, run by Biogen. The registered enrollment target is 400 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05925049, a study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Biogen.
- ACTIVE NOT RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status.
Conditions Studied
Interventions
- DRUG Natalizumab
Study Locations (1)
Massachusetts
- Research Site - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2023-06-30 |
| Est. Completion | 2026-03-31 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05925049
The ClinicalTrials.gov registry entry for NCT05925049 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (32% lower). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Natalizumab is the first listed.
NCT05925049 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05925049 about?
NCT05925049 is a clinical study titled "A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)". The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are...
What is the current status of trial NCT05925049?
This trial is currently active not recruiting. The enrollment target is 400 participants. The study started on 2023-06-30. Estimated completion is 2026-03-31.
What conditions does trial NCT05925049 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT05925049?
The interventions under investigation include: Natalizumab (DRUG).
Who is sponsoring clinical trial NCT05925049?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05925049 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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