NCT05925049Active, not recruiting
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)
An Observational Study Utilising Data From EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 21 Jun 2023
- Start date
- 30 Jun 2023
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Biogen
- Diseases
- Multiple sclerosis
- NCT number
- NCT05925049
What you commit to
- Study type: Observational
- Planned participants: 400
- From 30 Jun 2023 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For the natalizumab-naive and other MS mAb-naive cohort, participants who previously received natalizumab or other MS mAbs will be excluded.
Other
- For the natalizumab-experienced cohort, participants who are naive to natalizumab will be excluded.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Participants who are natalizumab-naïve and other MS mAb-naive and who start on natalizumab SC.
- Participants who have previously received natalizumab IV and switch from natalizumab IV to SC administration.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Cambridge | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.