Multiple SclerosisPhase 4NTZ2TTYNCT02769689
Methylprednisolone During the Switch Between Natalizumab and Fingolimod
A Phase 4 study testing Methylprednisolone, natalizumab (NTZ) and fingolimob (FTY) in people with Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Methylprednisolone, natalizumab (NTZ) and fingolimob (FTY)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2019to 20 Jul 2024
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Relapsing-Remitting Multiple Sclerosis (Mc Donald's 2010 criteria)
- EDSS<6.0
- At least18 natalizumab infusions
- Planned switch from natalizumab to fingolimod
- Aged between 18 and 65
- Patients must have received high dose IV methylprednisolone during the 5 previous years
Who cannot join
- Progressive MS
- Uncontrolled MS with natalizumab (existence of a relapse during the previous 12 months or existence of a gadolinium enhancing lesion on a MRI performed during the last 12 months)
- SEP de forme progressive
- Contra-indication to the use of high dose oral methylprednisolone
- Marked cognitive impairment altering protocole understanding
- Switch from natalizumab to a disease modifying treatment different from fingolimod
Show all 12Show fewer
- Contra-indication to fingolimod use
- Existence of a disease or condition that could alter study completion
- Chronic treatment with steroids
- Acute treatment with steroids (more than 300mg during the month prior to inclusion)
- Contra-indication to gadolinium containing products injection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Pierre CLAVELOU
About this study
Official title: Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)
Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT.
The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).
Read the detailed description
Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo.
Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.
A spinal and brain MRI will be performed at baseline (last NTZ perfusion, noted W0) and 16 to 18 weeks after. The last clinical follow-up will be made after 24 weeks.
- Conditions
- Multiple Sclerosis
- Being tested
- Methylprednisolone, Placebo, natalizumab (NTZ), fingolimob (FTY)
- Keywords
- Multiple sclerosis, Natalizumab, Fingolimod, Methylprednisolone
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
PlaceboDrug
Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
natalizumab (NTZ)Drug
Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
fingolimob (FTY)Drug
Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone | Experimental | The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY). Receives: Drug: Methylprednisolone; Drug: natalizumab (NTZ); Drug: fingolimob (FTY) |
| Placebo | Placebo comparator | Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of high dose methylprednisolone compared to that of a placebo
To evaluate the efficacy of high dose methylprednisolone given once a month during the washout period for the switch between natalizumab and fingolimod, compared to that of a placebo, on multiple sclerosis inflammatory rebound evaluated using MRI, 16 to 18 weeks after natalizumab discontinuation and clinically at 6 months
Measured: at 6 months
Secondary outcomes (5)
comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups
Measured: at 4 months
comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups
Measured: at 6 months
potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation
To study the potential correlations between previous MS activity (annualised relapse rate during the year before natalizumab initiation) and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation, in the whole group
Measured: at 6 months
adverse effects of high dose oral prednisolone
Measured: at 6 months
use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
To perform a cost utility analysis in order to evaluate the use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study start12 Jun 2019
- Primary completion20 Jun 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre CLAVELOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02769689
- Sponsor's protocol ID
- CHU-0259
- Other IDs
- 2015-003298-14, 2015
- Acronym
- NTZ2TTY
- Status last verified
- Aug 2022
- First submitted
- 17 Mar 2016
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)
- ClinicalTrials.gov ID
- NCT02769689
- Acronym / sponsor ID
- NTZ2TTY / CHU-0259
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Natalizumab, Fingolimod, Methylprednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 20 Jun 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 12 May 2016 (estimated)
- 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.
Progressive multifocal leukoencephalopathy (PML) is the most feared complication when natalizumab (NTZ) is used in the treatment of relapsing multiple sclerosis (MS). The risk of PML increases after 18 months of treatment. When switching from NTZ to another disease modifying treatment (DMT) in these MS patients with an active disease, there is a high risk of inflammatory reactivation. Nonetheless, a washout period of several weeks is necessary before initiating a new DMT.
The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY).
Detailed description
Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo.
Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.
A spinal and brain MRI will be performed at baseline (last NTZ perfusion, noted W0) and 16 to 18 weeks after. The last clinical follow-up will be made after 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Experimental | Drug: Methylprednisolone, Drug: natalizumab (NTZ), Drug: fingolimob (FTY)The primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between NTZ and Fingolimod (FTY). |
| Placebo | Placebo comparator | Drug: PlaceboIncluded patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Relapsing-Remitting Multiple Sclerosis (Mc Donald's 2010 criteria)
- EDSS<6.0
- At least18 natalizumab infusions
- Planned switch from natalizumab to fingolimod
- Aged between 18 and 65
Key exclusion criteria (12 listed)
- Progressive MS
- Uncontrolled MS with natalizumab (existence of a relapse during the previous 12 months or existence of a gadolinium enhancing lesion on a MRI performed during the last 12 months)
- SEP de forme progressive
- Contra-indication to the use of high dose oral methylprednisolone
- Marked cognitive impairment altering protocole understanding
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 |
|---|---|---|
| MethylprednisoloneIncluded patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo | Drug | Methylprednisolone |
| PlaceboIncluded patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo | Drug | Placebo |
| natalizumab (NTZ)Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo | Drug | Methylprednisolone |
| fingolimob (FTY)Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation. | Drug | Methylprednisolone |
Primary outcome
efficacy of high dose methylprednisolone compared to that of a placebo
Time frame: at 6 months
To evaluate the efficacy of high dose methylprednisolone given once a month during the washout period for the switch between natalizumab and fingolimod, compared to that of a placebo, on multiple sclerosis inflammatory rebound evaluated using MRI, 16 to 18 weeks after natalizumab discontinuation and clinically at 6 months
5 secondary outcomes
comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups
Time frame: at 4 months
comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups
Time frame: at 6 months
potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation
Time frame: at 6 months
adverse effects of high dose oral prednisolone
Time frame: at 6 months
use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
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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.
Pierre CLAVELOU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone, natalizumab (NTZ) and fingolimob (FTY) in people with Multiple Sclerosis, run by University Hospital, Clermont-Ferrand at 1 site 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of high dose methylprednisolone compared to that of a placebo (time frame: at 6 months). 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 9 Jan 2023.