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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT04832399 |
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Date of registration:
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16/03/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
TYPIFI |
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Scientific title:
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Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT) |
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Date of first enrolment:
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November 12, 2013 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04832399 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Documented diagnosis of Relapsing Remitting Multiple Sclerosis (McDonald 2010
Criteria).
- EDSS = 3.0.
- Must fulfill Tysabri indication (relapse and MRI criteria).
- Decision to start treatment with Natalizumab must precede enrollment.
- Up to four natalizumab infusions.
Key Exclusion Criteria:
- Any prior treatment with Natalizumab.
- Prior imunossupressive treatment (Mitoxantrone, Azathioprine, Methotrexate,
Cyclophosphamide, Mycophenolate, Cladribine, Rituximab).
- Contraindications to treatment with Natalizumab.
- History of Progressive Multifocal Leukoencephalopathy (PML) or other opportunistic
infections, or an increased risk for such infections.
- Immunocompromised at the time of enrollment. Known active malignancies.
- Inability to comply with study requirements.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Relapsing Remitting Multiple Sclerosis
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Intervention(s)
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Drug: Natalizumab
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Primary Outcome(s)
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Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
[Time Frame: Month 12]
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Overall Disease-Free Status at Month 12
[Time Frame: Month 12]
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Annualized Relapse Rate at Month 12 in Comparison to the Previous Year
[Time Frame: Month 12]
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Secondary Outcome(s)
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Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)
[Time Frame: Months 12, 24, 36 and 48]
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Clinical Disease-free Status Every 6 Months
[Time Frame: Every 6 months (Up to 48 months)]
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Overall Disease-Free Status at Months 24, 36 and 48
[Time Frame: Months 24, 36 and 48]
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Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire
[Time Frame: Months 12, 24, 36 and 48]
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QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II)
[Time Frame: Months 12, 24, 36 and 48]
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QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29)
[Time Frame: Months 12, 24, 36 and 48]
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Quality of life (QoL) Assessed Using Fatigue Severity Scale
[Time Frame: Months 12, 24, 36 and 48]
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MRI measures: T2, T1, T1 with Gadolinium (Gd)
[Time Frame: Months 12, 24, 36 and 48]
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QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test
[Time Frame: Months 12, 24, 36 and 48]
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Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)
[Time Frame: Months 12, 24, 36 and 48]
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Annualized Relapse Rate (ARR)
[Time Frame: Months 12, 24, 36 and 48]
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Secondary ID(s)
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PRT-TYS-12-10409
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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