Multiple Sclerosis, Relapsing-RemittingRELEVANTNCT04580381
Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Caen at 5 sites in France.
Trial summary
Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Natalizumab Injection [Tysabri]
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Sep 2020to 30 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving Natalizumab as disease-modifying monotherapy for RRMS
Who may be able to join
- Patients receiving at least 11 infusions of natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing
Who cannot join
- Patients for whom the NTZ infusion history and/or MRI and clinical history is not available.
- Patients with dosing gap defined as >=12 weeks between any two doses.
- Patients with over dose defined as <3 weeks between any two doses.
- Pregnancy during the follow-up period
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Department of Neurology, CHU Bobigny-Avicenne
Bobigny, 93000
Department of Neurology, CHU de Caen
Caen, 14000
Department of Neurology, Percy Military Hospital
Clamart, 92140
Department of Neurology, CHU Nice
Nice, 06000
Department of Neurology, CHU Toulouse Purpan
Toulouse, 31300
About this study
Official title: Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort
Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.
One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.
The objective of this study is to assess the efficacy in term of ARR and safety.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Natalizumab Injection [Tysabri]
- Keywords
- Natalizumab, Extended Interval Dosing
- 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.
Natalizumab Injection [Tysabri]Drug
Natalizumab infusion interval according to local practice defining the patient's group
| Study group | Role | What they receive |
|---|---|---|
| Standard Interval Dosing (SID) | Patients continuing Natalizumab treatment with standard interval dosing defined as > 11 infusions per year Receives: Drug: Natalizumab Injection [Tysabri] | |
| Extended Interval Dosing (EID) | Patients switching to extended interval dosing defined as ≤ 10 infusions per year Receives: Drug: Natalizumab Injection [Tysabri] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Ratio
relapse rate per patient per year
Measured: baseline to 12 month follow-up
Secondary outcomes (3)
Disability progression
Increase in EDSS score during the follow-up period
Measured: baseline to 12 month follow-up
NEDA-3 achievement
Estimation of the proportion of patients achieving NEDA-3 criteria at the end of the follow-up period
Measured: baseline to 12 month follow-up
Radiological activity
Detection of increase MRI activity defined as new or enlarged T2 lesions and/or new gadolinium enhancing lesions
Measured: baseline to 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580381
- Sponsor's protocol ID
- FRA-TYS-19-11504
- Acronym
- RELEVANT
- Status last verified
- Sep 2020
- First submitted
- 2 Oct 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pelle J, Briant AR, Branger P, Derache N, Arnaud C, Lebrun-Frenay C, Cohen M, Mondot L, De Seze J, Bigaut K, Collongues N, Kremer L, Ricard D, Bompaire F, Ohlmann C, Sallansonnet-Froment M, Ciron J, Biotti D, Pignolet B, Parienti JJ, Defer G. Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort. Neurol Ther. 2023 Apr;12(2):529-542. doi: 10.1007/s40120-023-00440-5. Epub 2023 Feb 10.
PubMed 36763307
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort
- ClinicalTrials.gov ID
- NCT04580381
- Acronym / sponsor ID
- RELEVANT / FRA-TYS-19-11504
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Natalizumab, Extended Interval Dosing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 8 Oct 2020 (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.
Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.
One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.
The objective of this study is to assess the efficacy in term of ARR and safety.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Interval Dosing (SID) | – | Drug: Natalizumab Injection [Tysabri]Patients continuing Natalizumab treatment with standard interval dosing defined as > 11 infusions per year |
| Extended Interval Dosing (EID) | – | Drug: Natalizumab Injection [Tysabri]Patients switching to extended interval dosing defined as ≤ 10 infusions per year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving Natalizumab as disease-modifying monotherapy for RRMS
Key inclusion criteria (1 listed)
- Patients receiving at least 11 infusions of natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing
Key exclusion criteria (4 listed)
- Patients for whom the NTZ infusion history and/or MRI and clinical history is not available.
- Patients with dosing gap defined as >=12 weeks between any two doses.
- Patients with over dose defined as <3 weeks between any two doses.
- Pregnancy during the follow-up period
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 |
|---|---|---|
| Natalizumab Injection [Tysabri]Natalizumab infusion interval according to local practice defining the patient's group | Drug | Extended Interval Dosing (EID), Standard Interval Dosing (SID) |
Primary outcome
Annualized Relapse Ratio
Time frame: baseline to 12 month follow-up
relapse rate per patient per year
3 secondary outcomes
Disability progression
Time frame: baseline to 12 month follow-up
NEDA-3 achievement
Time frame: baseline to 12 month follow-up
Radiological activity
Time frame: baseline to 12 month follow-up
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 9 Mar 2022.
- Derived from this study: PubMed 36763307Pelle J, Briant AR, Branger P, Derache N, Arnaud C, Lebrun-Frenay C, Cohen M, Mondot L, De Seze J, Bigaut K, Collongues N, Kremer L, Ricard D, Bompaire F, Ohlmann C, Sallansonnet-Froment M, Ciron J, Biotti D, Pignolet B, Parienti JJ, Defer G. Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort. Neurol Ther. 2023 Apr;12(2):529-542. doi: 10.1007/s40120-023-00440-5. Epub 2023 Feb 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Caen at 5 sites in France.
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 1 inclusion and 4 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 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
Annualized Relapse Ratio (time frame: baseline to 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04580381, which also lists 1 linked publication.
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 9 Mar 2022.