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)

• ClinicalTrials.gov Identifier: NCT05925049
• Recruitment Status: Active, not recruiting
• First Posted: June 29, 2023
• Last Update Posted: July 17, 2023
• Sponsor: Biogen
• Information provided by (Responsible Party): Biogen

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
Multiple Sclerosis	Drug: Natalizumab

Detailed Description:

The study will collect data prospectively and retrospectively.

Study Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Other
• Target Follow-Up Duration: 1 Year
• 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
• Actual Study Start Date: June 30, 2023
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: December 31, 2024

Groups and Cohorts

Group/Cohort	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 Name: 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 Name: Tysabri

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs) [ Time Frame: Up to 1.75 years ]

Secondary Outcome Measures :

1. Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs) [ Time Frame: Up to 1.75 years ]
2. Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status [ Time Frame: 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.
3. Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status [ Time Frame: Up to 1.75 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study will include available EU MS registry participants.

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.

Contacts and Locations

Locations

United States, Massachusetts

Research Site

Cambridge, Massachusetts, United States, 02142

Sponsors and Collaborators

Biogen

Investigators

• Study Director: Medical Director; Biogen

More Information

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT05925049
• Other Study ID Numbers: 101MS412; EUPAS48753 ( Other Identifier: EU PAS register number )
• First Posted: June 29, 2023
• Last Update Posted: July 17, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
• URL: https://vivli.org/

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Natalizumab; Immunologic Factors; Physiological Effects of Drugs