Clinical Trials Register

Summary
EudraCT Number:	2007-006338-32
Sponsor's Protocol Code Number:	WA21493
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-10-02
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2007-006338-32

A.3

Full title of the trial

Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS.

Studio di fase II, multicentrico, randomizzato, a gruppi paralleli, parzialmente in cieco, controllato da placebo e da Avonex, di reperimento della dose, teso a valutare l`efficacia, misurata tramite le lesioni cerebrali all`MRI, e la sicurezza a due regimi di dosaggio di ocrelizumab in pazienti affetti da RRMS.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI.

Studio clinico internazionale in pazienti con sclerosi multipla recidivante-remittente con lo scopo di valutare l`effetto di due diverse dosi di ocrelizumab paragonato a placebo o Avonex, esaminando l`effetto sulle lesioni al cervello mediante risonanza megnetica.

A.4.1

Sponsor's protocol code number

WA21493

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	F.Hoffmann-La Roche Ltd.
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	F. Hoffmann-La Roche Ltd.
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Roche S.p.A
B.5.2	Functional name of contact point	Head of Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Viale G.B. Stucchi 110
B.5.3.2	Town/ city	Monza (MB)
B.5.3.3	Post code	20900
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 039 247 5070
B.5.5	Fax number	+39 039 247 5085
B.5.6	E-mail	sergio.scaccabarozzi@roche.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Ocrelizumab
D.3.2	Product code	RO4964913
D.3.4	Pharmaceutical form	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ocrelizumab
D.3.9.1	CAS number	637334-45-3
D.3.9.2	Current sponsor code	RO4964913
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	anticorpo monoclonale
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Avonex
D.2.1.1.2	Name of the Marketing Authorisation holder	Biogen Idec Ltd
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INTERFERON BETA-1A
D.3.9.1	CAS number	220581-49-7
D.3.9.4	EV Substance Code	SUB12440MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	glicoproteina prodotta mediante tecnologia DNA-ricombinante

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Concentrate for solution for infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Relapsing-Remitting Multiple Sclerosis (RRMS).

Sclerosi multipla recidivante-remittente (RRMS).

E.1.1.1

Medical condition in easily understood language

Relapsing-Remitting Multiple Sclerosis (RRMS).

Sclerosi multipla recidivante-remittente (RRMS).

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10063399
E.1.2	Term	Relapsing-remitting multiple sclerosis
E.1.2	System Organ Class	10029205 - Nervous system disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To investigate the effect of ocrelizumab given as two dose regimens of 600 or 1000 mg intravenously on the total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at weeks 12, 16, 20 and 24 as compared to placebo.

Indagare l`effetto di ocrelizumab somministrato per endovena rispetto al placebo in due regimi di dosaggio di 600 o 1000 mg sul numero totale di lesioni T1 captanti il gadolinio osservate con RM del cervello alle settimane 12, 16, 20 e 24.

E.2.2

Secondary objectives of the trial

`- Annualized protocol defined relapse rate by week 24; - Proportion of patients who remain relapse-free by week 24; - Total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at week 4, 8, 12, 16, 20 and 24; - Total number of new and/or persisting gadolinium-enhancing T1 lesions at week 4, 8, 12, 16, 20 and 24; - Change in total volume of T2 lesions on MRI scans of the brain from baseline to week 24; - To evaluate the safety and tolerability of 2 dose regimens of ocrelizumab compared to placebo and Avonex at week 24 and the overall safety of ocrelizumab for up to 96 weeks; -ˆ' To investigate the pharmacokinetics and other pharmacodynamic study endpoints of ocrelizumab.

- Tasso annualizzato delle recidive definite dal protocollo alla settimana 24;- Proporzione di pazienti che restano liberi da recidiva alla settimana 24;- Numero totale di lesioni T1 captanti il gadolinio osservate nelle RM del cervello alle settimane 4,8,12,16,20 e 24;- Numero totale di lesioni T1 captanti il gadolinio nuove e/o persistentialle settimane 4,8,12,16,20 e 24;- Variazione dal basale alla settimana 24 del volume totale delle lesioni T2 evidenziate dalla RM del cervello;- Valutare la sicurezza e la tollerabilita` di 2 regimi di dosaggio di ocrelizumab rispetto al placebo e ad Avonex alla settimana 24 e la sicurezza complessiva di ocrelizumab per 96 settimane;- Investigare la farmacocinetica e altri endpoint farmacodinamici di studio di ocrelizumab.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments; 2. Relapsing-remitting MS, in accordance with the revised McDonald criteria (2005); 3. Ages 18-55 years inclusive; 4. At least two documented relapses within the last 3 years prior to screening, at least one of which occurred within the last year prior to screening; 5. EDSS at baseline from 1.0 to 6.0 points; 6. Evidence of MS disease burden as defined below: a. At least six T2 lesions on an MRI scan done in the year prior to screening, based on local reading. Should an MRI scan be unavailable within the last year or showing less than six T2 lesions, a screening MRI scan* with at least six T2 lesions is required for the patient to be eligible, or b. Patient had 2 documented relapses within the year prior to screening; 7. For sexually active female and male patients of reproductive potential, use of reliable means of contraception as described below as a minimum (adherence to local requirements, if more stringent, is required): - Two methods of contraception throughout the trial, including the active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or until their B-cells have repleted, whichever is longer. - Acceptable methods of contraception include one primary (e.g. systemic hormonal contraception or tubal ligation of the female partner, vasectomy of the male partner) AND one secondary barrier method (e.g. latex condoms, spermicide) OR a double barrier method (e.g. latex condom, intrauterine device, vaginal ring or pessary plus spermicide (e.g. foam, vaginal suppository, gel, cream). 8. For patients of non reproductive potential (adherence to local requirements, if more stringent, is required): a. Women may be enrolled if postmenopausal (i.e. spontaneous amenorrhea for the past year confirmed by an FSH level greater than 40 mIU/mL unless the patient is receiving a hormonal therapy for their menopause or surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy); b. Men may be enrolled if they are surgically sterile (castration)

1. Capacita` di dare il consenso informato scritto e di aderire al programma di valutazioni previste dal protocollo; 2. SM recidivante-remittente, secondo la definizione data dai criteri rivisti di McDonald (2005); 3. Eta` compresa tra 18 e 55 anni compiuti; 4. Almeno due recidive documentate negli ultimi 3 anni precedenti lo screening, almeno una delle quali si deve essere verificata nell`anno precedente lo screening 5. EDSS al basale tra 1.0 e 6.0 punti; 6. Evidenza di attivita` della SM secondo la definizione data qui sotto: a. Almeno sei lesioni T2 evidenziate in una RM effettuata nell`anno precedente lo screening, secondo la lettura del laboratorio locale. Se non dovesse essere disponibile una RM dell`anno precedente o se questa dovesse evidenziare meno di sei lesioni T2, per determinare l`idoneita` del paziente e` richiesta una RM* di screening con almeno sei lesioni T2, OPPURE b. Il paziente ha avuto due recidive documentate nell`anno precedente lo screening; 7. Per i pazienti di entrambi i sessi sessualmente attivi e in grado di avere figli, e` necessario l`utilizzo di metodi contraccettivi affidabili secondo le indicazioni date piu` avanti, come minimo (e` obbligatoria l`aderenza ai requisiti locali, se piu` rigorosi): - Due metodi anticoncezionali per tutta la durata della sperimentazione, compresa la fase di trattamento attivo E per le 48 settimane successive all`assunzione dell`ultima dose di ocrelizumab, o fino al momento in cui si sia ripristinato il livello di linfociti B, a seconda di quale dei due eventi si verifichi piu` tardi. - Tra i metodi contraccettivi accettabili rientrano uno primario (p.es. contraccezione ormonale sistemica o legatura delle tube della partner di sesso femminile, vasectomia del partner di sesso maschile) E un metodo barriera secondario (p.es. preservativo, spermicida) OPPURE un doppio metodo barriera (p. es. preservativo, spirale intrauterina, anello vaginale o pessario piu` spermicida (p. es. schiuma, ovuli vaginali, gel, crema)). 8. Per i pazienti non in grado di avere figli (e` obbligatoria l`aderenza ai requisiti locali, se piu` rigorosi ): a. Le donne potranno essere arruolate se in postmenopausa (vale a dire amenorrea spontanea nell`ultimo anno confermata da un livello di FSH superiore a 40 mIU/mL, a meno che la paziente non stia ricevendo terapia ormonale per la menopausa o sia chirurgicamente sterile (vale a dire isterectomia, ooforectomia bilaterale completa); b. Gli uomini potranno essere arruolati se chirurgicamente sterili (castrazione)

E.4

Principal exclusion criteria

9. Secondary or primary progressive multiple sclerosis at screening (Visit 1); 10. Disease duration of more than 15 years in patients with an EDSS `‰¤ 2.0; 11. Incompatibility with MRI (contraindications for MRI include but is not restrictive to known allergy to gadolinium contrast dyes, renal impairment which would contraindicate gadolinium injection, claustrophobia, weight `‰¥ 140 kg, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.); 12. Contra-indications to or intolerance of oral or i.v. corticosteroids, including methylprednisolone administered i.v., according to the country label, including: a. Psychosis not yet controlled by a treatment; b. Hypersensitivity to any of the constituents; 13. Known presence of other neurologic disorders, including but not limited to, the following: a. History of ischemic cerebrovascular disorders (e.g. stroke, transient ischemic attack) or ischemia of the spinal cord; b. History or known presence of CNS or spinal cord tumor (e.g. meningioma, glioma); c. History or known presence of potential metabolic causes of myelopathy (e.g. untreated vitamin B12 deficiency); e. History or known presence of infectious causes of myelopathy (e.g. syphilis, Lyme disease, HTLV-1, herpes zoster myelopathy); f. History of genetically inherited progressive CNS degenerative disorder (e.g. hereditary paraparesis; MELAS [mitochondrial myopathy, encephalopathy, lactacidosis, stroke] syndrome); g. Neuromyelitis optica; h. History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjogren`s syndrome, Behcet`s disease); i. History or known presence of sarcoidosis; j. History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression); k. History of progressive multifocal leukoencephalopathy (PML). .... et al.

9. Sclerosi multipla progressiva secondaria o primaria allo screening (Visita 1); 10. Durata della malattia superiore ai 15 anni in pazienti con EDSS `‰¤ 2.0; 11. Incompatibilita` con la RM (le controindicazioni alla RM comprendono, senza limitarsi a quanto in elenco, nota allergia ai mezzi di contrasto a base di gadolinio, insufficienza renale che sconsiglierebbe l`iniezione di gadolinio, claustrofobia, peso `‰¥ 140 kg, pacemaker, impianti cocleari, clip vascolari intracraniche, chirurgia nelle 6 settimane precedenti l`ingresso nello studio, impianto di stent coronarico nelle 8 settimane precedenti il momento in cui si prevede di effettuare la RM, ecc.); 12. Controindicazioni o intolleranza ai corticosteroidi orali o EV, compreso il metilprednisolone somministrato EV, secondo le indicazioni in etichetta nei singoli paesi, tra cui: a. Psicosi non ancora controllata da una terapia; b. Ipersensibilita` a uno degli ingredienti; 13. Presenza nota di altri disturbi neurologici, compresi, ma senza limitarsi a quanto in elenco, i seguenti: a. Storia di disturbi cerebrovascolari ischemici (p. es. ictus, attacchi ischemici transitori) o ischemia della corda spinale; b. Storia o nota presenza di tumore del CNS o della corda spinale (p. es. meningioma, glioma); c. Storia o nota presenza di potenziali cause metaboliche di mielopatia (p.es. carenza di vitamina B12 non trattata); e. Storia o nota presenza di cause infettive di mielopatia (p.es. sifilide, malattia di Lyme, HTLV-1, mielopatia da Herpes zoster); f. Storia di disturbi degenerativi ereditari progressivi del SNC (p.es. paraparesi ereditaria; sindrome MELAS [encefalomiopatia mitocondriale, acidosi lattica, episodi simil-stroke]); g. Neuromielite ottica; h. Storia o nota presenza di disturbi autoimmuni sistemici che potenzialmente provochino malattia neurologica progressiva (p.es., lupus, sindrome dell`anticorpo antifosfolipide, sindrome di Sjogren, malattia di Behcet); i. Storia o nota presenza di sarcoidosi; j. Storia di traumi cerebrali o della corda spinale severi e clinicamente significativi (p.es., contusione cerebrale, compressione della corda spinale); k. Storia di leucoencefa-lopatia multifocale progressiva (PML) ... et al.

E.5 End points

E.5.1

Primary end point(s)

Valutare l`'effetto di ocrelizumab somministrato per via endovenosa in due regimi di dosaggio di 600 o 1000 mg sul numero totale di lesioni T1 gadolinio-positive rilevate con RM del cervello alle settimane 12, 16, 20 e 24, in confronto a placebo.

E.5.1.1

Timepoint(s) of evaluation of this end point

Weekes 12, 16, 20 and 24.

Settimane 12,16,20,24.

E.5.2

Secondary end point(s)

• The annualized protocol defined relapse rate by Week 24 • Proportion of patients who remain relapse-free by Week 24 (protocol defined relapses) • The total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at weeks 4, 8, 12, 16, 20 and 24 • The total number of new and/or persisting gadolinium-enhancing T1 lesions on MRI scans of the brain at weeks 4, 8, 12, 16, 20 and 24 • Change in total volume of T2 lesions on MRI scans of the brain from baseline to Week 24.

E.5.2.1

Timepoint(s) of evaluation of this end point

Weeks 4, 8, 12, 16, 20 and 24

Settimane 4, 8, 12, 16, 20 e 24.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Clinical genotyping

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Mexico

Russian Federation

Switzerland

Ukraine

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Date of the last patient`s last visit for the OLE.

Data della visita dell`ultimo paziente che completa la fase di estensione del trattamento in aperto.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

200

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-10-02.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

180

F.4.2.2

In the whole clinical trial

200

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Upon completion of both the Treatment Period and Treatment-free Period, patients will be invited to participate in the Open Label Extension (OLE) period of the study where they will receive continued open-label treatment with ocrelizumab.

Dopo la conclusione del trattamento e della fase di wash-out ai pazienti sara' offerta la possibilita' di partecipare ad un periodo di estensione del trattamento in aperto.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2008-09-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-04-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-02-16

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