Relapsing Remitting Multiple SclerosisTYPIFINCT04832399
Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
An observational study of Relapsing Remitting Multiple Sclerosis, run by Biogen at 18 sites in Portugal.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Natalizumab
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 18 sitesPortugal
- Study dates
- 12 Nov 2013to 2 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Portugal18 sites
Research Site
Amadora, 2720-276
Research Site
Angra do Heroísmo, 9700-049
Research Site
Aveiro, 3810-164
Research Site
Braga, 4710-243
Research Site
Coimbra, 3004-561
Research Site
Faro, 8000-386
Research Site
Funchal, 9000-177
Research Site
Guimarães, 4835-044
Research Site
Leiria, 2410-197
Research Site
Lisbon, 1649-028
Research Site
Loures, 2674-514
Research Site
Matosinhos Municipality, 4450-021
Research Site
Penafiel, 4564-007
Research Site
Porto, 4200-319
Research Site
Santa Maria da Feira, 4520-220
Research Site
Setúbal, 2910-446
Research Site
Viana do Castelo, 4904-858
Research Site
Vila Nova de Gaia, 4434-502
About this study
Official title: Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)
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).
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Natalizumab
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NatalizumabDrug
Also called Tysabri, BG00002
As described in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Natalizumab | Natalizumab 300 mg is administered by intravenous infusion once every 4 weeks. Receives: Drug: Natalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Disease-Free Status at Month 12
Measured: Month 12
Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
Measured: Month 12
Annualized Relapse Rate at Month 12 in Comparison to the Previous Year
Measured: Month 12
Secondary outcomes (11)
Overall Disease-Free Status at Months 24, 36 and 48
Measured: Months 24, 36 and 48
Clinical Disease-free Status Every 6 Months
Measured: Every 6 months (Up to 48 months)
Annualized Relapse Rate (ARR)
Measured: Months 12, 24, 36 and 48
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).
Measured: Months 12, 24, 36 and 48
MRI measures: T2, T1, T1 with Gadolinium (Gd)
Measured: Months 12, 24, 36 and 48
Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)
Measured: Months 12, 24, 36 and 48
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.
Measured: Months 12, 24, 36 and 48
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.
Measured: Months 12, 24, 36 and 48
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.
Measured: Months 12, 24, 36 and 48
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.
Measured: Months 12, 24, 36 and 48
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).
Measured: Months 12, 24, 36 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start12 Nov 2013
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832399
- Sponsor's protocol ID
- PRT-TYS-12-10409
- Acronym
- TYPIFI
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tysabri in Early Relapsing Remitting Multiple Sclerosis Patients - TYPIFI (Tysabri Patient Initiation After Failure of the Initial DMT)
- ClinicalTrials.gov ID
- NCT04832399
- Acronym / sponsor ID
- TYPIFI / PRT-TYS-12-10409
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2013 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Natalizumab | – | Drug: NatalizumabNatalizumab 300 mg is administered by intravenous infusion once every 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants diagnosed with relapsing remitting multiple sclerosis (RRMS) that have been prescribed natalizumab under standard clinical care.
Key inclusion criteria (5 listed)
- 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 (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NatalizumabAlso: Tysabri, BG00002As described in the treatment arm. | Drug | Natalizumab |
Primary outcome
Overall Disease-Free Status at Month 12
Time frame: Month 12
Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year
Time frame: Month 12
Annualized Relapse Rate at Month 12 in Comparison to the Previous Year
Time frame: Month 12
11 secondary outcomes
Overall Disease-Free Status at Months 24, 36 and 48
Time frame: Months 24, 36 and 48
Clinical Disease-free Status Every 6 Months
Time frame: Every 6 months (Up to 48 months)
Annualized Relapse Rate (ARR)
Time frame: Months 12, 24, 36 and 48
Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)
Time frame: Months 12, 24, 36 and 48
MRI measures: T2, T1, T1 with Gadolinium (Gd)
Time frame: Months 12, 24, 36 and 48
Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)
Time frame: Months 12, 24, 36 and 48
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
Quality of life (QoL) Assessed Using Fatigue Severity Scale
Time frame: Months 12, 24, 36 and 48
QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test
Time frame: Months 12, 24, 36 and 48
QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II)
Time frame: Months 12, 24, 36 and 48
QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: Months 12, 24, 36 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsing Remitting Multiple Sclerosis, run by Biogen at 18 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Disease-Free Status at Month 12 (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.