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Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants (TYPIFI)

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: NCT04832399
Recruitment Status : Active, not recruiting
First Posted : April 5, 2021
Last Update Posted : April 13, 2022
Sponsor:
Information provided by (Responsible Party):
Biogen

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
Relapsing Remitting Multiple Sclerosis Drug: Natalizumab

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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 : November 12, 2013
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab

Group/Cohort 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




Primary Outcome Measures :
  1. Overall Disease-Free Status at Month 12 [ Time Frame: Month 12 ]
  2. Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year [ Time Frame: Month 12 ]
  3. Annualized Relapse Rate at Month 12 in Comparison to the Previous Year [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  1. Overall Disease-Free Status at Months 24, 36 and 48 [ Time Frame: Months 24, 36 and 48 ]
  2. Clinical Disease-free Status Every 6 Months [ Time Frame: Every 6 months (Up to 48 months) ]
  3. Annualized Relapse Rate (ARR) [ Time Frame: Months 12, 24, 36 and 48 ]
  4. Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained) [ Time Frame: 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) [ Time Frame: Months 12, 24, 36 and 48 ]
  6. Cognitive Impairment Using Symbol Digit Modalities Test (SDMT) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
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.


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): NCT04832399


Locations
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Portugal
Research Site
Amadora, Portugal, 2720-276
Research Site
Angra do Heroismo, Portugal, 9700-049
Research Site
Aveiro, Portugal, 3810-164
Research Site
Braga, Portugal, 4710-243
Research Site
Coimbra, Portugal, 3004-561
Research Site
Faro, Portugal, 8000-386
Research Site
Funchal, Portugal, 9000-177
Research Site
Guimaraes, Portugal, 4835-044
Research Site
Leiria, Portugal, 2410-197
Research Site
Lisboa, Portugal, 1649-028
Research Site
Loures, Portugal, 2674-514
Research Site
Matosinhos, Portugal, 4450-021
Research Site
Penafiel, Portugal, 4564-007
Research Site
Porto, Portugal, 4200-319
Research Site
Santa Maria da Feira, Portugal, 4520-220
Research Site
Setubal, Portugal, 2910-446
Research Site
Viana do Castelo, Portugal, 4904-858
Research Site
Vila Nova de Gaia, Portugal, 4434-502
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT04832399    
Other Study ID Numbers: PRT-TYS-12-10409
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 13, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
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