Clinical trial NCT04832399: Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Official title: Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.

Brief summary: The purpose of this study is to evaluate the impact of an early treatment with Natalizumab on the management of the progressive nature of Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Disease-Free Status at Month 12
timeFrame: Month 12
measure: Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
timeFrame: Month 12
measure: Annualized Relapse Rate at Month 12 in Comparison to the Previous Year
timeFrame: Month 12
Secondary outcomes:
measure: Overall Disease-Free Status at Months 24, 36 and 48
timeFrame: Months 24, 36 and 48
measure: Clinical Disease-free Status Every 6 Months
timeFrame: Every 6 months (Up to 48 months)
measure: Annualized Relapse Rate (ARR)
timeFrame: Months 12, 24, 36 and 48
measure: Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)
timeFrame: Months 12, 24, 36 and 48
measure: MRI measures: T2, T1, T1 with Gadolinium (Gd)
timeFrame: Months 12, 24, 36 and 48
measure: Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)
timeFrame: Months 12, 24, 36 and 48
measure: Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Months 12, 24, 36 and 48
measure: Quality of life (QoL) Assessed Using Fatigue Severity Scale
timeFrame: Months 12, 24, 36 and 48
measure: QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test
timeFrame: Months 12, 24, 36 and 48
measure: QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II)
timeFrame: Months 12, 24, 36 and 48
measure: QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Months 12, 24, 36 and 48
Other outcomes:
Locations:
city: Amadora
country: Portugal
facility: Research Site
city: Angra do Heroismo
country: Portugal
facility: Research Site
city: Aveiro
country: Portugal
facility: Research Site
city: Braga
country: Portugal
facility: Research Site
city: Coimbra
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Funchal
country: Portugal
facility: Research Site
city: Guimaraes
country: Portugal
facility: Research Site
city: Leiria
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Loures
country: Portugal
facility: Research Site
city: Matosinhos
country: Portugal
facility: Research Site
city: Penafiel
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Santa Maria da Feira
country: Portugal
facility: Research Site
city: Setubal
country: Portugal
facility: Research Site
city: Viana do Castelo
country: Portugal
facility: Research Site
city: Vila Nova de Gaia
country: Portugal
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: