A Study for Tysabri Participant Preference
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ClinicalTrials.gov Identifier: NCT05304520 |
Recruitment Status :
Completed
First Posted : March 31, 2022
Last Update Posted : May 20, 2024
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Condition or disease | Intervention/treatment |
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Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: Natalizumab |
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 |
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.
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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. |
- 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?".
- 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?".
- Number of Participants Positive for Anti-Natalizumab-Antibody [ Time Frame: Baseline, Month 6 and 12 ]
- Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody [ Time Frame: Baseline, Month 6 and 12 ]
- 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.
- 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.
- 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.
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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 |
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.
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
Study Director: | Medical Director | Biogen |
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 20, 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/ |
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 |
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 |