Relapsing Remitting Multiple Sclerosis Clinical Trial
— TYPIFIOfficial title:
Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)
Verified date | February 2024 |
Source | Biogen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Biogen |
Portugal,
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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