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)

Sponsor

Biogen (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925049

Collaborator

(none)

400

Enrollment

18.3

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Natalizumab

Detailed Description

The study will collect data prospectively and retrospectively.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Anticipated Study Start Date :

Jun 23, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1: Naive Participants Per standard of care, participants with MS enrolled in selected MS registries, who are natalizumab-naïve and other MS mAb-therapy-naive will receive natalizumab 300 mg, SC injection according to decision of the treating physician.	Drug: Natalizumab Administered as specified in the treatment arm. Other Names: Tysabri
Cohort 2: Natalizumab Experienced Per standard of care, participants with MS enrolled in selected MS registries, who have previously received natalizumab IV will be switched from natalizumab IV to SC administration to receive natalizumab 300 mg, SC injection according to decision of the treating physician.	Drug: Natalizumab Administered as specified in the treatment arm. Other Names: Tysabri

Arm

Intervention/Treatment

Cohort 1: Naive Participants

Per standard of care, participants with MS enrolled in selected MS registries, who are natalizumab-naïve and other MS mAb-therapy-naive will receive natalizumab 300 mg, SC injection according to decision of the treating physician.

Drug: Natalizumab

Administered as specified in the treatment arm.

Other Names:

Tysabri

Cohort 2: Natalizumab Experienced

Per standard of care, participants with MS enrolled in selected MS registries, who have previously received natalizumab IV will be switched from natalizumab IV to SC administration to receive natalizumab 300 mg, SC injection according to decision of the treating physician.

Drug: Natalizumab

Administered as specified in the treatment arm.

Other Names:

Tysabri

Outcome Measures

Primary Outcome 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]

Secondary Outcome Measures

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]
SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product.
Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status [Up to 1.75 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Biogen

Investigators

Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biogen

ClinicalTrials.gov Identifier:

NCT05925049

Other Study ID Numbers:

101MS412
EUPAS48753

First Posted:

Jun 29, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Natalizumab

Study Results

No Results Posted as of Jun 29, 2023