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A Study for Tysabri Participant Preference

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05304520
Recruitment Status : Completed
First Posted : March 31, 2022
Last Update Posted : May 17, 2024
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.

Condition or disease Intervention/treatment
Relapsing-Remitting Multiple Sclerosis (RRMS) Drug: Natalizumab

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Study Type : Observational
Actual Enrollment : 318 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
Actual Study Start Date : October 12, 2021
Actual Primary Completion Date : April 30, 2024
Actual Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Group/Cohort Intervention/treatment
On Natalizumab: Switcher IV to SC Cohort
Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
Drug: Natalizumab
Administered as specified in the treatment arm.

Natalizumab-Naive IV Cohort
Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months
Drug: Natalizumab
Administered as specified in the treatment arm.

Natalizumab-Naive SC Cohort
Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
Drug: Natalizumab
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6 [ Time Frame: Month 6 ]
    The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".

  2. Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12 [ Time Frame: Month 12 ]
    The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".


Secondary Outcome Measures :
  1. Number of Participants Positive for Anti-Natalizumab-Antibody [ Time Frame: Baseline, Month 6 and 12 ]
  2. Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody [ Time Frame: Baseline, Month 6 and 12 ]
  3. Annual Relapse Rate [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]
    An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. Annual relapse rate is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.

  4. Time to Relapse [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]
    An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings.

  5. Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab [ Time Frame: Baseline, Months 3, 6, 9, and 12 ]
    Progression is defined as an increase of at least 1.5 points from a baseline Expanded Disability Status Scale (EDSS) score of 0, or at least 1.0 point from a baseline EDSS score >0 and ≤5.5 points, or at least 0.5 point from a baseline EDSS score ≥6.0. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) is reported. Improvement is defined analogously, and all other cases are considered as stable disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with RRMS who are receiving or will initiate natalizumab (intravenous or subcutaneous) as standard of care/routine clinical practice will be enrolled.
Criteria

Key Inclusion Criteria:

  • Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
  • In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC

Key Exclusion Criteria:

  • Progressive forms of MS
  • Contraindication to natalizumab treatment according to natalizumab SmPC
  • Concomitant treatment with other drugs for treating RRMS
  • Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05304520


Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT05304520    
Other Study ID Numbers: DE-TYS-11923
First Posted: March 31, 2022    Key Record Dates
Last Update Posted: May 17, 2024
Last Verified: May 2024
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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