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TYPIFI: Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants

Sponsor
Biogen (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04832399
Collaborator
(none)
60
Enrollment
18
Locations
117.6
Anticipated Duration (Months)
3.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)
Actual Study Start Date :
Nov 12, 2013
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Natalizumab

Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks.

Drug: Natalizumab
As described in the treatment arm.
Other Names:
  • Tysabri
  • BG00002

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Disease-Free Status at Month 12 [Month 12]

    2. Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year [Month 12]

    3. Annualized Relapse Rate at Month 12 in Comparison to the Previous Year [Month 12]

    Secondary Outcome Measures

    1. Overall Disease-Free Status at Months 24, 36 and 48 [Months 24, 36 and 48]

    2. Clinical Disease-free Status Every 6 Months [Every 6 months (Up to 48 months)]

    3. Annualized Relapse Rate (ARR) [Months 12, 24, 36 and 48]

    4. Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained) [Months 12, 24, 36 and 48]

      The EDSS is used to quantify disability due to symptoms of MS and to track changes in disability status over time. Scores range from 0 (normal neurological exam) to 10 (death due to multiple sclerosis).

    5. MRI measures: T2, T1, T1 with Gadolinium (Gd) [Months 12, 24, 36 and 48]

    6. Cognitive Impairment Using Symbol Digit Modalities Test (SDMT) [Months 12, 24, 36 and 48]

    7. Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire [Months 12, 24, 36 and 48]

      The WPAI questionnaire is a validated instrument to measure impairments in work and activities. The WPAI yields four types of scores: 1. Absenteeism (work time missed) 2. Presenteesism (impairment at work / reduced on-the-job effectiveness) 3. Work productivity loss (overall work impairment / absenteeism plus presenteeism) 4. Activity Impairment. WPAI outcomes are expressed as impairment percentages ranging from 0-100%, with higher numbers indicating greater impairment and less productivity.

    8. Quality of life (QoL) Assessed Using Fatigue Severity Scale [Months 12, 24, 36 and 48]

      The FSS is a self-assessment questionnaire that provides a score as a measurement of the severity of fatigue. It consists of 9 questions scored from 1 to 7. A low value (e.g., 1); indicates strong disagreement with the statement, whereas a high value (e.g., 7); indicates strong agreement. A total score of 36 or more suggests presence of fatigue.

    9. QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test [Months 12, 24, 36 and 48]

      MSFC has 2 component- timed 25-foot walk (T25FW) and 9-hole peg test (9HPT) [dominant and nondominant hands]. The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT-2)/2, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.

    10. QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II) [Months 12, 24, 36 and 48]

      BDI-II Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

    11. QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29) [Months 12, 24, 36 and 48]

      MSIS-29 is a brief self-administered instrument measuring physical (20 items) and psychological (9 items) impact of Multiple Sclerosis (MS). Each of the 29 items on MSIS-29 tool is a question that ask for participants views about the impact of MS on their day to day lives. Each item is scored on 1 to 5 (1=Not at all; 5=Extremely).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Amadora Portugal 2720-276
    2 Research Site Angra do Heroismo Portugal 9700-049
    3 Research Site Aveiro Portugal 3810-164
    4 Research Site Braga Portugal 4710-243
    5 Research Site Coimbra Portugal 3004-561
    6 Research Site Faro Portugal 8000-386
    7 Research Site Funchal Portugal 9000-177
    8 Research Site Guimaraes Portugal 4835-044
    9 Research Site Leiria Portugal 2410-197
    10 Research Site Lisboa Portugal 1649-028
    11 Research Site Loures Portugal 2674-514
    12 Research Site Matosinhos Portugal 4450-021
    13 Research Site Penafiel Portugal 4564-007
    14 Research Site Porto Portugal 4200-319
    15 Research Site Santa Maria da Feira Portugal 4520-220
    16 Research Site Setubal Portugal 2910-446
    17 Research Site Viana do Castelo Portugal 4904-858
    18 Research Site Vila Nova de Gaia Portugal 4434-502

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT04832399
    Other Study ID Numbers:
    • PRT-TYS-12-10409
    First Posted:
    Apr 5, 2021
    Last Update Posted:
    Apr 13, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Multiple Sclerosis, Relapsing-Remitting
    Sclerosis
    Natalizumab

    Study Results

    No Results Posted as of Apr 13, 2022