Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
250
Countries
1
Sites
24
Multiple Sclerosis
To demonstrate the non-inferiority of DMTs withdrawal compared to treatment continuation at 2 years, on disability progression, in “inactive” SPMS patients older than 50 years. The definition of “inactive” SPMS patients refers to the Lublin classification : SPMS patients without recent evidence of focal inflammatory ac…
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Rennes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 24 Jan 2019 → ongoing
- Decision date (initial)
- 2024-10-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516628-32-00
- EudraCT number
- 2018-001292-21
- ClinicalTrials.gov
- NCT03653273
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacoeconomic, Efficacy
To demonstrate the non-inferiority of DMTs withdrawal compared to treatment continuation at 2 years, on disability progression, in “inactive” SPMS patients older than 50 years.
The definition of “inactive” SPMS patients refers to the Lublin classification : SPMS patients without recent evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no radiological activity)
Secondary objectives 6
- To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for Disability progression using a composite score
- To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for Relapses
- To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for MRI parameters
- To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for Disease-free survival
- To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for Patients quality of life
- To compare the 2 groups at 2 years (treatment withdrawal vs treatment continuation) for Medico-economic impact: cost-utility study (differential cost per QALY gained)
Conditions and MedDRA coding
Multiple Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10063400 | Secondary progressive multiple sclerosis | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | M0-M24 Controlled, randomized, rater-masked study with 2 parallel groups, comparing a treatment withdrawal group (1) to a treatment continued group (2) for 2 years (non-inferiority analysis).
In the group 1 (treatment withdrawal group), some patients will possibly resume their treatment. These patients will be followed for 2 years according to the trial schedule. In the statistical analyses, they will be included in the group 1. Indeed, the main objective of the present study is to evaluate the risk of disability progression after an attempt of DMT withdrawal.
In group 2 (treatment continued group), the previously established DMT will be continued at the same dose.
|
Randomised Controlled | None | Active Comparator: DMT continuation: The previously established therapy will be continued at the same dose during two years Experimental: DMT withdrawal: DMT will be immediately stopped after randomization.These patients will be followed for 2 years. |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2018-001292-21 | Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years, Arrêt des traitements de fond à visée immunologique chez les patients de plus de 50 ans ayant une sclérose en plaques secondairement progressive |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients ≥ 50 years old
- Secondary progressive phenotype for at least 3 years ; The secondary progressive phenotype will be defined as progressive deterioration of disability not due to relapse, with an increase of at least 1 EDSS point since the beginning of the progressive phase (or 0.5 EDSS point if EDSS score > 5.5)
- Disease modifying therapy of MS for at least 3 years (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, rituximab, ocrelizumab); Both patients with the same DMT or with successive DMTs during 3 years can be included. It is important to note that patients could have been treated with fingolimod or natalizumab 2 or 3 years before inclusion, but not during the year before inclusion
- No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan)
- EDSS ≥ 3
Exclusion criteria 9
- Patients treated with mitoxantrone or alemtuzumab, during the previous 3 years before inclusion
- Patients treated with natalizumab or fingolimod during the year before inclusion
- Change of disease modifying therapy of MS for less than a year
- Other neurological or systemic disease
- Incapacity to understand or sign the consent form
- Contraindication to MRI
- Pregnancy or breast-feeding
- Patient in another clinical trial
- Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (eg minors, protected adults, …)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of patients experiencing disability progression (confirmed at 6 months) at 2 years. Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was more than 5.5.
Secondary endpoints 6
- Disability - Time from DMT withdrawal to disability progression confirmed at 6 months; - Change in a composite disability progression score (increase in the EDSS score, or an increase in the time to perform the timed 25-foot walk ≥ 20%, or an increase in the time to complete the 9-hole peg test ≥ 20%) confirmed at 6 months; - Change in the SDMT score from baseline to 2-year;
- Relapses - Percentage of patients with at least one relapse from baseline to 2-year; - Annualized relapse rate during 2-year; - Time from DMT withdrawal to first relapse;
- MRI - Percentage of patients with one or more new or enlarging brain MRI lesions from baseline to 2-year; - Percentage of patients with at least one gadolinium enhancing lesion(s) at 6 months, and/or 1 year,and/or 2-year; - Change in brain volume from baseline to 2-year;
- Disease free survival - Percentage of patients with no evidence of disease activity (NEDA 3: no clinical relapse, no MRI activity, no disability progression) at 2-year; - Percentage of patients who resume DMT in the treatment withdrawal group at 2-year
- Quality of life - Change in the SEP-59 score from baseline to 2-year; - Change in the EuroQOL EQ-5D from baseline to 2-year;
- Medico economic impact - Incremental Cost Effectiveness Ratio (ICER) defined as the cost for QALY gained in “treatment withdrawal group” versus “treatment continued group”.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 19
SUB13608MIG · Substance
- Active substance
- Dimethyl Fumarate
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 480 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05647MIG · Substance
- Active substance
- Azathioprine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB03360MIG · Substance
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB121707 · Substance
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12440MIG · Substance
- Active substance
- Interferon BETA-1A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 30 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12440MIG · Substance
- Active substance
- Interferon BETA-1A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 44 µg microgram(s)
- Max total dose
- 44 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12440MIG · Substance
- Active substance
- Interferon BETA-1A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 44 µg microgram(s)
- Max total dose
- 44 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB121165 · Substance
- Active substance
- Peginterferon BETA-1A
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 125 µg microgram(s)
- Max total dose
- 125 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25218 · Substance
- Active substance
- Teriflunomide
- Pharmaceutical form
- COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 14 mg milligram(s)
- Max total dose
- 14 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12432MIG · Substance
- Active substance
- Interferon BETA-1B
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 250 µg microgram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13971MIG · Substance
- Active substance
- Glatiramer Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13971MIG · Substance
- Active substance
- Glatiramer Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/square meter
- Max total dose
- 750 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/square meter
- Max total dose
- 750 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Rennes
- Sponsor organisation
- Centre Hospitalier Universitaire De Rennes
- Address
- 2 Rue Henri Le Guilloux
- City
- Rennes
- Postcode
- 35000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Rennes
- Contact name
- Dr Anne KERBRAT
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Rennes
- Contact name
- Dr Anne KERBRAT
Locations
1 EU/EEA country · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 250 | 24 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
Neurology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Regional De Marseille
Neurology, 264 Rue Saint Pierre, 13005, Marseille
Centre Hospitalier Regional Universitaire De Tours
Neurology, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Regional Et Universitaire De Brest
Neurology, Boulevard Tanguy Prigent, 29200, Brest
Centre Hospitalier Universitaire De Rennes
Neurology, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Intercommunal De Cornouaille
Neurology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Les Hopitaux De Chartres
Neurology, 4 Rue Claude Bernard, 28630, Le Coudray
Centre Hospitalier Universitaire De Montpellier
Neurology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Nantes
Neurology, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire D'Angers
Neurology, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Dijon
Neurology, 14 Rue Paul Gaffarel, 21000, Dijon
Centre Hospitalier Universitaire De Nimes
Neurology, Place Du Professeur Robert Debre, 30029, Nimes Cedex 9
Assistance Publique Hopitaux De Paris
Neurology, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Hospices Civils De Lyon
Neurology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Nice
Neurology, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Lille
Neurology, Hôpital Salengro, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Les Hopitaux Universitaires De Strasbourg
Neurology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
University Hospital Of Clermont-Ferrand
Neurology, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Hospital Foch
Neurology, 40 Rue Worth, 92150, Suresnes
Hopitaux Universitaires Pitie Salpetriere
Neurology, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Bordeaux
Neurology, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Intercommunal De Poissy Saint Germain
Neurology, 20 Rue Armagis, Bp 231, St Germain En Laye Cedex
Groupement Des Hopitaux De L'Institut Catholique De Lille
Neurology, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Centre Hospitalier De Libourne Robert Boulin
Neurology, 112 Rue De La Marne, Bp 199, Libourne Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2019-01-24 | 2019-01-24 | 2025-01-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2024-516628-32-00_Protocol_STOP-I-SEP_for publication | 19.0 |
| Recruitment arrangements (for publication) | 2024-516628-32-00_Recruitment arrangements_STOP-I-SEP | 1.0 |
| Subject information and informed consent form (for publication) | 2024-516628-32-00_SIS and ICF_Addendum_medical-economic_STOP-I-SEP_OK | 1.0 |
| Subject information and informed consent form (for publication) | 2024-516628-32-00_SIS and ICF_caregiver_approach_STOP-I-SEP | 3.0 |
| Subject information and informed consent form (for publication) | 2024-516628-32-00_SIS and ICF_patient_STOP-I-SEP | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Aubagio_7 mg-14 mg_Comprime pellicule_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Avonex_30 g_Solution injectable_Stylo prerempli_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Betaferon_250 g-mL_Poudre et solvant pour solution injectable_STOP-I-SEP | 7.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Cellcept_500 mg_Comprime pellicule_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Copaxone_20 mg-mL_Solution injectable en seringue preremplie_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_ENDOXAN_50 mg_Comprime enrobe_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Extavia_250 g-mL_Poudre et solvant pour solution injectable_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_IMETH 10 mg_ solution injectable en seringue preremplie_STOP-I-SEP | 7.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Imurel_50 mg_Comprime pellicule_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Mabthera_100 mg-500 mg_solution a diluer pour perfusion_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_NOVATREX_comprime_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Ocrevus_300 mg_solution a diluer pour perfusion_STOP-I-SEP | 8.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Plegridy_125 g_Solution injectable en seringue ou stylo prerempli_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Rebif_22 g_Solution injectable en cartouche_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Rebif_22 g_Solution injectable en seringue preremplie_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Rebif_22 g_Solution injectable en stylo prerempli_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Rebif_44 g_Solution injectable en cartouche_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Rebif_44 g_Solution injectable en seringue preremplie_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Rebif_44 g_Solution injectable en stylo prerempli_STOP-I-SEP | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | 2024-516628-32-00_SmPC_Tecfidera_240 mg_Gelule gastro-resistante_STOP-I-SEP | 8.0 |
| Synopsis of the protocol (for publication) | 2024-516628-32-00_Protocol synopsis_FR_STOP-I-SEP | 19.0 |
| Synopsis of the protocol (for publication) | 2024-516628-32-00_Protocol synopsis_FR_STOP-I-SEP_version tracking | 19.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | France | Acceptable 2024-10-10
|
2024-10-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-04 | France | Acceptable 2025-05-19
|
2025-05-23 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-07 | France | Acceptable 2025-12-11
|
2025-12-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-12 | France | Acceptable | 2026-04-10 |