Clinical trial NCT05925049: 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2023-06-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include available EU MS registry participants.

Brief 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.

Detailed description: The study will collect data prospectively and retrospectively.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)
timeFrame: Up to 1.75 years
Secondary outcomes:
measure: Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs)
timeFrame: Up to 1.75 years
measure: Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status
timeFrame: Up to 1.75 years
measure: Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status
timeFrame: Up to 1.75 years
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Research Site
state: Massachusetts
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: