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)
What it found
No result yet.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)
Up to 1.75 years
Other measures (3)
Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs)
Up to 1.75 years
Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status
Up to 1.75 years
SafetyPercentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status
Up to 1.75 years
Relapses
Who could take part
Relapsing MS · 18 to 64
Key Inclusion Criteria: * 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. Key Exclusion Criteria : * For the natalizumab-naive and other MS mAb-naive cohort, participants who previously received natalizumab or other MS mAbs will be excluded. * For the natalizumab-experienced cohort, participants who are naive to natalizumab will be excluded. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
Related trials
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumar…
Recruiting
Still running
- SATURATE-MS
Stopped early
Stopped early
- A Study to Investigate the Radiological Onset of Action A…
Phase 4 · Stopped early
Stopped early
- The 'Wearing Off' Effect of DMT
Completed
No result found
- A Study to Evaluate Efficacy, Safety, Pharmacokinetics, a…
Phase 3 · Stopped early
Stopped: not working
- A Study for Tysabri Participant Preference
Completed
Result in a paper, not read yet
History
Started
Jun 2023
Main results due
Oct 2026
Finished
Oct 2026
Assembled by software from public sources and not checked by people. Each record links to its source. Report an error