Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Not authorised
Participants planned
338
Countries
3
Sites
24
Neurological Disease
To provide continued treatment with Roche IMP(s)-based therapy for eligible patients with a neurological disease still on study treatment at the time of roll-over from the parent study who do not have reasonable access to the study treatment locally.
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Decision date (initial)
- 2024-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann-La Roche AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Therapy
To provide continued treatment with Roche IMP(s)-based therapy for eligible patients with a neurological disease still on study treatment at the time of roll-over from the parent study who do not have reasonable access to the study treatment locally.
Secondary objectives 1
- Not applicable (N/A)
Conditions and MedDRA coding
Neurological Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10029298 | Neurological disorder NOS | 10029205 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | AN OPEN-LABEL, MULTICENTER EXTENSION STUDY IN PATIENTS WITH NEUROLOGICAL DISEASE PREVIOUSLY ENROLLED This is an open-label, multicenter, extension study. Patients with a neurological disease who
are receiving clinical benefit from Roche IMP(s) monotherapy or in combination with other
agent(s) during participation in a Genentech- or Roche-sponsored study including rollover of
those patients to an Investigator-Initiated Study (IIS), who are eligible to continue treatment and who
do not have reasonable access to the study treatment locally, may continue to receive study
treatment in this extension study following roll-over from the parent study.
Prior to enrollment in this extension study, the investigator will assess whether continuing
treatment in the study is in the best interest for each patient by assessing their individual benefit
risk.
|
Not Applicable | None | Arm A: Multiple Sclerosis patients continued access to Ocrevus |
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2021-006107-15 | LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS: CONSONANCE EXTENSION STUDY | |
| 2017-001313-93 | AN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS, ESTUDIO ABIERTO DE UN SOLO GRUPO Y CUATRO AÑOS DE DURACIÓN PARA EVALUAR LA EFECTIVIDAD Y LA SEGURIDAD DEL TRATAMIENTO CON OCRELIZUMAB EN PACIENTES CON ESCLEROSIS MÚLTIPLE PROGRESIVA, OTEVŘENÉ, JEDNORAMENNÉ, ČTYŘLETÉ KLINICKÉ HODNOCENÍ ZA ÚČELEM POSOUZENÍ ÚČINNOSTI A BEZPEČNOSTI LÉČBY OCRELIZUMABEM U PACIENTŮ S PROGRESIVNÍ ROZTROUŠENOU SKLERÓZOU, OTEVŘENÉ, JEDNORAMENNÉ, ČTYŘLETÉ KLINICKÉ HODNOCENÍ ZA ÚČELEM POSOUZENÍ ÚČINNOSTI A BEZPEČNOSTI LÉČBY OCRELIZUMABEM U PACIENTŮ S PROGRESIVNÍ ROZTROUŠENOU SKLERÓZOU, OTEVŘENÉ, JEDNORAMENNÉ, ČTYŘLETÉ KLINICKÉ HODNOCENÍ ZA ÚČELEM POSOUZENÍ ÚČINNOSTI A BEZPEČNOSTI LÉČBY OCRELIZUMABEM U PACIENTŮ S PROGRESIVNÍ ROZTROUŠENOU SKLERÓZOU, OTEVŘENÉ, JEDNORAMENNÉ, ČTYŘLETÉ KLINICKÉ HODNOCENÍ ZA ÚČELEM POSOUZENÍ ÚČINNOSTI A BEZPEČNOSTI LÉČBY OCRELIZUMABEM U PACIENTŮ S PROGRESIVNÍ ROZTROUŠENOU SKLERÓZOU, OTEVŘENÉ, JEDNORAMENNÉ, ČTYŘLETÉ KLINICKÉ HODNOCENÍ ZA ÚČELEM POSOUZENÍ ÚČINNOSTI A BEZPEČNOSTI LÉČBY OCRELIZUMABEM U PACIENTŮ S PROGRESIVNÍ ROZTROUŠENOU SKLERÓZOU, AZ OCRELIZUMAB KEZELÉS HATÉKONYSÁGÁNAK ÉS BIZTONSÁGOSSÁGÁNAK NYÍLT ELRENDEZÉSŰ, 4 ÉVIG TARTÓ, EGYKAROS VIZSGÁLATA PROGRESSZÍV SZKLERÓZIS MULTIPLEXBEN SZENVEDŐ BETEGEK ESETÉBEN, STUDIO IN APERTO, A SINGOLO BRACCIO, DELLA DURATA DI 4 ANNI, PER VALUTARE L’EFFICACIA E LA SICUREZZA DEL TRATTAMENTO CON OCRELIZUMAB IN PAZIENTI CON SCLEROSI MULTIPLA PROGRESSIVA | |
| 2020-005448-48 | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS, RANDOMIZOVANÉ, OTEVŘENÉ, MULTICENTRICKÉ KLINICKÉ HODNOCENÍ NON-INFERIORITY, S PARALELNÍMI SKUPINAMI, FÁZE III, ZKOUMAJÍCÍ FARMAKOKINETIKU, FARMAKODYNAMIKU, BEZPEČNOST, RADIOLOGICKÉ A KLINICKÉ ÚČINKY OCRELIZUMABU PODÁVANÉHO SUBKUTÁNNĚ OPROTI OCRELIZUMABU PODÁVANÉMU INTRAVENÓZNĚ U PACIENTŮ S ROZTROUŠENOU SKLERÓZOU, RANDOMIZOVANÉ, OTEVŘENÉ, MULTICENTRICKÉ KLINICKÉ HODNOCENÍ NON-INFERIORITY, S PARALELNÍMI SKUPINAMI, FÁZE III, ZKOUMAJÍCÍ FARMAKOKINETIKU, FARMAKODYNAMIKU, BEZPEČNOST, RADIOLOGICKÉ A KLINICKÉ ÚČINKY OCRELIZUMABU PODÁVANÉHO SUBKUTÁNNĚ OPROTI OCRELIZUMABU PODÁVANÉMU INTRAVENÓZNĚ U PACIENTŮ S ROZTROUŠENOU SKLERÓZOU, RANDOMIZOVANÉ, OTEVŘENÉ, MULTICENTRICKÉ KLINICKÉ HODNOCENÍ NON-INFERIORITY, S PARALELNÍMI SKUPINAMI, FÁZE III, ZKOUMAJÍCÍ FARMAKOKINETIKU, FARMAKODYNAMIKU, BEZPEČNOST, RADIOLOGICKÉ A KLINICKÉ ÚČINKY OCRELIZUMABU PODÁVANÉHO SUBKUTÁNNĚ OPROTI OCRELIZUMABU PODÁVANÉMU INTRAVENÓZNĚ U PACIENTŮ S ROZTROUŠENOU SKLERÓZOU, RANDOMIZOVANÉ, OTEVŘENÉ, MULTICENTRICKÉ KLINICKÉ HODNOCENÍ NON-INFERIORITY, S PARALELNÍMI SKUPINAMI, FÁZE III, ZKOUMAJÍCÍ FARMAKOKINETIKU, FARMAKODYNAMIKU, BEZPEČNOST, RADIOLOGICKÉ A KLINICKÉ ÚČINKY OCRELIZUMABU PODÁVANÉHO SUBKUTÁNNĚ OPROTI OCRELIZUMABU PODÁVANÉMU INTRAVENÓZNĚ U PACIENTŮ S ROZTROUŠENOU SKLERÓZOU, ESTUDIO DE FASE III DE NO INFERIORIDAD, ALEATORIZADO, ABIERTO, DE GRUPOS PARALELOS Y MULTICÉNTRICO PARA INVESTIGAR LA FARMACOCINÉTICA, LA FARMACODINÁMICA, LA SEGURIDAD Y LOS EFECTOS RADIOLÓGICOS Y CLÍNICOS DE OCRELIZUMAB SUBCUTÁNEO EN COMPARACIÓN CON OCRELIZUMAB INTRAVENOSO EN PACIENTES CON ESCLEROSIS MÚLTIPLE, STUDIO DI FASE III DI NON-INFERIORITÀ, RANDOMIZZATO, IN APERTO, A GRUPPI PARALLELI E MULTICENTRICO PER VALUTARE LA FARMACOCINETICA, LA FARMACODINAMICA, LA SICUREZZA E GLI EFFETTI RADIOLOGICI E CLINICI DI OCRELIZUMAB PER VIA SOTTOCUTANEA VERSUS OCRELIZUMAB PER VIA ENDOVENOSA IN PAZIENTI CON SCLEROSI MULTIPLA |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 1. Signed extension study Informed Consent Form
- 2. Eligible for continuing on Roche IMP-based therapy at the time of roll-over from the parent study, as per the parent study protocol
- 3. First dose of study treatment in this extension study will be received within the treatment window allowed by the parent study.
- 4. Continue to benefit from the Roche active substance at the time of roll-over from the parent study as assessed by the investigator
- 5. Ability to comply with the extension study protocol, per investigator’s judgement
- 6. Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential
Exclusion criteria 6
- 1. Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
- 2. Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is reasonably accessible to the patient
- 3. Study treatment is available via Post Trial Access Program (PTAP) in the patient’s country and is accessible to the patient
- 4. Treatment with any other neurological treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this extension study
- 5. Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)
- 6. Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Not available
Secondary endpoints 1
- N/A
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD113235 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 6000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
PRD10886506 · Product
- Active substance
- Ocrelizumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 920 mg milligram(s)
- Max total dose
- 9200 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 4
SCP10332310 · ATC
- Active substance
- Dexamethasone Acetate
- Route of administration
- ORAL AND IV
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 220 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
R06A · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL AND IV
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 550 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- R06A — ANTIHISTAMINES FOR SYSTEMIC USE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
-
N02B · Product
- Pharmaceutical form
- -
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 11000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- N02B — OTHER ANALGESICS AND ANTIPYRETICS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lidocaine Hydrochloride Monohydrate
SCP1095637 · ATC
- Active substance
- Lidocaine Hydrochloride Monohydrate
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 1100 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Third parties 2
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Limited ORG-100008700
|
Uxbridge, United Kingdom | Data management |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
Locations
3 EU/EEA countries · 24 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Not authorised | 90 | 8 |
| France | Not authorised | 69 | 12 |
| Germany | Not authorised | 37 | 4 |
| Rest of world
United States
|
— | 142 | — |
Investigational sites
Fakultni Nemocnice Ostrava
Neurology, 17. Listopadu 1790/5, 708 00, Poruba
Fakultni Nemocnice U Sv Anny V Brne
Neurology, Pekarska 53, Stare Brno, Brno-Stred
Fakultni Nemocnice Hradec Kralove
Neurology, Sokolska 581, 500 03, Novy Hradec Kralove
Krajska zdravotni a.s.
Neurology, Duchcovska 53, 415 01, Teplice
Nemocnice Jihlava prispevkova organizace
Neurology, Vrchlickeho 4630/59, 586 01, Jihlava 1
Nemocnice Pardubickeho kraje a.s.
Neurology, Kyjevska 44 Pardubicky, 530 03, Pardubice
Vseobecna Fakultni Nemocnice V Praze
Neurology, Karlovo Namesti 554/32, Nove Mesto, Prague 2
Fakultni Nemocnice V Motole
Neurology, V Uvalu 84/1, Motol, Prague 5
Hospices Civils De Lyon
Service neurologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire Amiens Picardie
Service neurologie, 1 Place Victor Pauchet, 80080, Amiens
Centre Hospitalier Universitaire De Nimes
Service neurologie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
University Hospital Of Clermont-Ferrand
Service neurologie, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Centre Hospitalier Universitaire De Rennes
Service neurologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nice
Service neurologie, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire De Caen Normandie
Service neurologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Service neurologie, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier De La Cote Basque
Service neurologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Les Hopitaux Universitaires De Strasbourg
Service neurologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Lille
Service neurologie, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Centre Hospitalier Universitaire De Montpellier
Service neurologie, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
DKD HELIOS Klinik Wiesbaden GmbH
Neurologie, Aukammallee 33, Bierstadt, Wiesbaden
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
-, Muensterplatz 32, Mitte, Ulm
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
Studienzentrum Nordwest, Lange Strasse 25, 26655, Westerstede
Technische Universitat Dresden
Neurologische Uniklinik, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-18 | France | Not acceptable 2024-04-22
|
2024-04-23 |