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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04832399
Other study ID # PRT-TYS-12-10409
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 12, 2013
Est. completion date October 2, 2023

Study information

Verified date February 2024
Source Biogen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Natalizumab
As described in the treatment arm.

Locations

Country Name City State
Portugal Research Site Amadora
Portugal Research Site Angra do Heroismo
Portugal Research Site Aveiro
Portugal Research Site Braga
Portugal Research Site Coimbra
Portugal Research Site Faro
Portugal Research Site Funchal
Portugal Research Site Guimaraes
Portugal Research Site Leiria
Portugal Research Site Lisboa
Portugal Research Site Loures
Portugal Research Site Matosinhos
Portugal Research Site Penafiel
Portugal Research Site Porto
Portugal Research Site Santa Maria da Feira
Portugal Research Site Setubal
Portugal Research Site Viana do Castelo
Portugal Research Site Vila Nova de Gaia

Sponsors (1)

Lead Sponsor Collaborator
Biogen

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Disease-Free Status at Month 12 Month 12
Primary Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year Month 12
Primary Annualized Relapse Rate at Month 12 in Comparison to the Previous Year Month 12
Secondary Overall Disease-Free Status at Months 24, 36 and 48 Months 24, 36 and 48
Secondary Clinical Disease-free Status Every 6 Months Every 6 months (Up to 48 months)
Secondary Annualized Relapse Rate (ARR) Months 12, 24, 36 and 48
Secondary Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained) 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). Months 12, 24, 36 and 48
Secondary MRI measures: T2, T1, T1 with Gadolinium (Gd) Months 12, 24, 36 and 48
Secondary Cognitive Impairment Using Symbol Digit Modalities Test (SDMT) Months 12, 24, 36 and 48
Secondary Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire 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. Months 12, 24, 36 and 48
Secondary Quality of life (QoL) Assessed Using Fatigue Severity Scale 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. Months 12, 24, 36 and 48
Secondary QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test 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. Months 12, 24, 36 and 48
Secondary QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II) 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. Months 12, 24, 36 and 48
Secondary QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29) 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). Months 12, 24, 36 and 48
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