Clinical Trials Register

Summary
EudraCT Number:	2011-002333-19
Sponsor's Protocol Code Number:	OMS112831
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:	2012-03-14
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

2011-002333-19

A.3

Full title of the trial

Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months’ administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS).

Studio randomizzato, in doppio cieco, controllato verso placebo, a gruppi paralleli, per la definizione della dose, per studiare l'efficacia sulla RMN e la sicurezza della somministrazione di ofatumumab per sei mesi in pazienti con sclerosi multipla recidivante remittente.

A.3.1

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

Subcutaneous Ofatumumab in Relapsing Remitting Multiple Sclerosis.

Ofatumumab sottocutaneo nel trattamento della sclerosi multipla recidivante remittente.

A.3.2

Name or abbreviated title of the trial where available

Ofatumumab sub-cutaneous in RRMS

Ofatumumab sottocutaneo in RRMS

A.4.1

Sponsor's protocol code number

OMS112831

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	GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.
B.1.3.4	Country	United Kingdom
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	Pharma R&D, GlaxoSmithkline Ltd.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithkline
B.5.2	Functional name of contact point	GSK Clinical Support Helpdesk
B.5.3	Address:
B.5.3.1	Street Address	Iron Bridge Road, Stockley Park West
B.5.3.2	Town/ city	Uxbridge, Middlesex
B.5.3.3	Post code	UB11 1BU
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	+44 20 8990 4466 - 800786766
B.5.5	Fax number	+44 20 8990 1234
B.5.6	E-mail	GSKClinicalSupportHD@gsk.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	Yes
D.2.1.1.1	Trade name	Arzerra
D.2.1.1.2	Name of the Marketing Authorisation holder	Glaxo Group Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	OFATUMUMAB
D.3.9.1	CAS number	679818-59-8
D.3.9.2	Current sponsor code	GSK1841157
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB25221
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	No

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	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous 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.

Sclerosi multipla recidivante remittente.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	SOC
E.1.2	Classification code	10029205
E.1.2	Term	Nervous system disorders
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 determine whether ofatumumab 3, 30 or 60 milligrams (mg) given subcutaneously (SQ), reduces the cumulative number of new T1 GdE brain lesions over a period of 12 weeks, as compared with placebo, in subjects with RRMS.

Determinare se ofatumumab 3, 30 o 60 milligrammi (mg) somministrato per via sottocutanea (sc), riduce il numero cumulativo di nuove lesioni cerebrali T1 GdE in un periodo di 12 settimane, rispetto a placebo, in soggetti con RRMS.

E.2.2

Secondary objectives of the trial

To evaluate the robustness of the MRI efficacy of ofatumumab 3, 30 or 60 milligrams (mg) given subcutaneously (SQ) over the 24 week treatment period relative to the first 12 weeks of the treatment period • To evaluate the safety and tolerability over a period of 24 weeks of a range of SQ ofatumumab doses in subjects with RRMS • To make a preliminary assessment of the efficacy of a range of SQ doses of ofatumumab in subjects with RRMS based on frequency of clinical relapses over a period of 24 weeks • To determine the extent of B-cell depletion for a range of SQ doses of ofatumumab in subjects with RRMS • To determine the extent of B-cell repletion following cessation of SQ ofatumumab treatment within specified time periods in subjects with RRMS • To evaluate the immunogenicity of SQ ofatumumab in subjects with RRMS For other study objectives please refer page12 of protocol.

•Valutare la durata dell’efficacia determinata mediante RMN di ofatumumab 3, 30 o 60 milligrammi (mg) somministrato per via sottocutanea (sc) nel corso delle 24 settimane di trattamento in relazione alle prime 12 settimane di trattamento.•Valutare la sicurezza e la tollerabilità in un periodo di 24 settimane di una gamma di dosi di ofatumumab sc in soggetti con RRMS.•Effettuare una valutazione preliminare dell’efficacia di una gamma di dosi di ofatumumab sc in soggetti con RRMS sulla base della frequenza di recidive cliniche in un periodo di 24 settimane.•Determinare il livello di deplezione delle cellule B per una gamma di dosi di ofatumumab in soggetti con RRMS.•Determinare il livello di deplezione delle cellule B a seguito dell’interruzione del trattamento con ofatumumab sc entro periodi di tempo specificati in soggetti con RRMS. •Valutare l’immunogenicità di ofatumumab sc in soggett

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Able to provide signed, written informed consent to participate in the study 2. 18-55 years of age. 3. Definite diagnosis of MS according to the 2010 revisions of the McDonald diagnostic criteria for MS [Polman, 2011]. 4. Subjects do not have any manifestation of another type of MS other than RRMS. 5. Subjects must have a relapsing-remitting course of disease with at least one of the following prior to screening: A. At least one confirmed relapse within the previous year or B. At least two confirmed relapses within the previous 2 years or C. At least one relapse in the previous 2 years, with a GdE brain lesion on an MRI scan in the past year. 6. Expanded Disability Status Scale (EDSS) score of 0-5.5 (inclusive) at screening. 7. Neurologically stable with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase (subjects who relapse during the screening Phase can be re-screened, once the relapse has resolved). 8. A female subject is eligible to enter the study if she is: A. Of non-childbearing potential B. Of childbearing potential and NOT pregnant or nursing, has a negative serum pregnancy test at screening, and agrees to one of the following: a. Complete abstinence from intercourse for the period from consent into the study until 6 months after the last dose of investigational product; or, b. Consistent and correct use of one of the following acceptable methods of birth control for the period from consent into the study until 6 months after the last dose of investigational product: i. Oral contraceptives (either combined or progesterone only) ii. Injectable progesterone iii. Levonorgestrel implants iv. Estrogenic vaginal ring v. Percutaneous contraceptive patches vi. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of <1% per year vii. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study; this male must be the sole partner for the subject viii. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). A female is considered “Non-childbearing potential” if she is status-post hysterectomy, status-post surgical removal of both ovaries, has current, documented tubal ligation, or is postmenopausal and >2 years without menses. Female subjects who are post-menopausal <2 years must be confirmed menopausal by Follicle Stimulating Hormone (FSH) and estradiol levels. A female is considered “childbearing potential” if she has functional ovaries, ducts, and uterus with no impairment that would cause sterility. This includes women with oligomenorrhea (even severe), and women who are perimenopausal or who have just begun to menstruate.

1.Soggetti in grado di fornire il proprio consenso informato scritto per la partecipazione allo studio. 2.Età di 18-55 anni. 3.Diagnosi di SM definita secondo la revisione del 2010 dei criteri diagnostici McDonald per la SM. 4.Soggetti che non presentano nessuna manifestazione di un altro tipo di SM diversa dalla RRMS. 5.Soggetti che presentano un decorso recidivante-remittente della malattia, con almeno uno dei seguenti elementi prima dello screening: A.Almeno una recidiva confermata nell’anno precedente oppure B.Almeno due recidive confermate nei 2 anni precedenti oppure C.Almeno una recidiva nei 2 anni precedenti, con una lesione cerebrale GdE ad una RMN eseguita nell’anno precedente. 6.Punteggio Expanded Disability Status Scale (EDSS) di 0-5.5 (estremi inclusi) allo screening. 7.Soggetti stabili da un punto di vista neurologico senza alcuna evidenza di recidiva per almeno 30 giorni prima dell’inizio dello screening e durante la fase di screening (i soggetti che manifestano una recidiva durante la fase di screening possono essere nuovamente sottoposti a screening una volta che la recidiva si è risolta). 8.I soggetti di sesso femminile sono eleggibili per entrare nello studio se: A.Non potenzialmente fertili B.Potenzialmente fertili e NON in gravidanza o allattamento, con test di gravidanza sul siero negativo allo screening, e che acconsentano ad una delle seguenti opzioni: a.Astinenza completa dai rapporti sessuali nel periodo compreso tra la firma del consenso fino a 6 mesi dopo l’ultima somministrazione del farmaco in studio, oppure, b.Uso costante e corretto di uno dei seguenti metodi contraccettivi accettabili nel periodo compreso tra la firma del consenso fino a 6 mesi dopo l’ultima somministrazione del farmaco in studio: i.Contraccettivi orali (sia in combinazione che progesterone somministrato da solo) ii.Progesterone iniettabile iii.Impianti di levonorgestrel iv.Anello vaginale ad estrogeni v.Cerotti contraccettivi transdermici vi.Dispositivo intrauterino (IUD) o sistema intrauterino (IUS) con un tasso di insuccesso documentato <1% all’anno vii.Sterilizzazione del partner maschile (vasectomia con documentazione di azoospermia) prima dell’ingresso del soggetto di sesso femminile nello studio; il partner deve essere l’unico partner del soggetto in studio. viii.Metodo a doppia barriera: preservativo e dispositivo occlusivo (diaframma o dispositivo cervicale) con agente spermicida vaginale (schiuma/gel/film/crema/supposta). Una donna è considerata ''non potenzialmente fertile'' se in stato post-isterectomia, post-rimozione di entrambe le ovaie, se con legatura tubarica documentata o in fase di post-menopausa con > 2 anni senza ciclo mestruale. I soggetti di sesso femminile che sono in fase di post-menopausa da meno di due anni devono avere conferma dello stato di menopausa tramite misura dei livelli di ormone follicolo stimolante ed estradiolo. Una donna è considerata ''potenzialmente fertile'' se ha ovaie, dotti e utero funzionanti senza deterioramento che causi sterilità. Questa definizione include donne con oligomenorrea (anche severa) e donne che sono in fase di perimenopausa o che hanno appena iniziato ad avere il ciclo mestruale.

E.4

Principal exclusion criteria

Subjects meeting any of the following criteria are not eligible and cannot enroll in the study: 1. Unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia,hypersensitivity to contrast media, or who lack adequate peripheral venous access). 2. Any clinically significant brain abnormality other than MS found on MRI. 3. Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML (see Appendix 4, Section 11.4, for PML monitoring algorithm). 4. Subjects whom experience a relapse during the Screening Phase. These subjects may be eligible for re-screening after consultation with GSK. 5. History of clinically significant CNS trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease. 6. Prior treatment with any of the following: A. Systemic glucocorticoids or Adrenocorticotrophic hormone (ACTH) within one month prior to screening B. Receipt of a live vaccine within 6 weeks prior to screening C. Glatiramer acetate (Copaxone) or IFN-β (Betaferon, Betaseron, Avonex, or Rebif) within 3 months prior to screening D. Any immunomodulatory therapies, excluding glatiramer acetate or IFN-β, within 6 months prior to screening including natalizumab and fingolimod (Gilenya), immunoglobulin, or plasma exchange/plasmapheresis E. Any monoclonal antibodies at any time, other than natalizumab (Tysabri) F. Any lymphocyte-depleting therapies, including, but not limited to: cladribine, anti-CD4, total body irradiation, or bone marrow transplantation G. Any immunosuppressive agents, including, but not limited to: mitoxantrone, azathioprine, cyclosporine, cyclophosphamide, or tacrolimus 7. Past or current history of medically significant adverse effects (including allergic reactions) from: A. Cetirizine (or equivalent) B. Paracetamol/acetaminophen C. Corticosteroids 8. Known hypersensitivity to components of the investigational product. 9. Past or current malignancy, except for A. Cervical carcinoma Stage 1B or less B. Non-invasive basal cell and squamous cell skin carcinoma C. Cancer diagnoses with a duration of complete response (remission) >5 years D. A history of hematologic malignancy excludes a subject from participation, regardless of response. 10. Electrocardiogram (ECG) showing a clinically significant abnormality at Screening or showing an average QTcB or QTcF interval ≥450 msec (≥480 msec for subjects with a Bundle Branch Block) over 3 consecutive ECGs. 11. Significant concurrent, uncontrolled medical condition including, but not limited to, cardiac, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric, or neurological disease which in the opinion of the investigator could affect the subject’s safety, impair the subject’s reliable participation in the trial, impair the evaluation of endpoints, or necessitate the use of medication not allowed by this protocol. 12. History of severe, clinically significant CNS trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease. 13. Chronic or ongoing active infectious disease requiring long term systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, or active hepatitis C. 14. Previous serious opportunistic or atypical infections. 15. Positive polymerase chain reaction (PCR) screening for JC Virus as measured by plasma JCV DNA. 16. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.

1.Soggetti non in grado di sottoporsi a RMN (ad esempio, con pacemaker, claustrofobia severa, ipersensibilità a mezzi di contrasto o che non presentano adeguato accesso venoso periferico). 2.Qualsiasi anormalità cerebrale clinicamente significativa diversa dalla SM rilevata alla RMN. 3.Risultati neurologici coerenti con Leucoencefalopatia Multifocale Progressiva (Progressive Multifocal Leukoencephalopathy - PML) o PML confermata (fare riferimento all’Appendice 4, Sezione 11.4 del protocollo per l’algoritmo di monitoraggio della PML). 4.Soggetti che manifestano una recidiva durante la fase di screening. Questi soggetti possono essere eleggibili per un nuovo screening previo confronto con GSK. 5.Anamnesi di trauma del SNC clinicamente significativo (ad esempio, danno cerebrale traumatico, contusione cerebrale, compressione del midollo spinale) o storia o presenza di mielopatia dovuta a compressione del midollo spinale, patologia discale o vertebrale. 6.Trattamento pregresso con uno qualsiasi dei seguenti: A.Glucocorticoidi sistemici od ormone adrenocorticotropico (Adrenocorticotrophic Hormone - ACTH) nel mese precedente lo screening B.Somministrazione di un vaccino vivo nelle 6 settimane precedenti lo screening C.Glatiramer acetato (Copaxone) o IFN-β (Betaferon, Betaseron, Avonex, o Rebif) nei 3 mesi precedenti lo screening D.Qualsiasi terapia immunomodulatoria, escluso glatiramer acetato o IFN-β, nei 6 mesi precedenti lo screening compresi natalizumab e fingolimod (Gilenya), immunoglobuline, o scambio plasmatico/plasmaferesi E.Qualsiasi anticorpo monoclonale in qualsiasi momento, ad eccezione di natalizumab (Tysabri) F.Qualsiasi terapia con deplezione dei linfociti, compresi, a titolo esemplificativo: cladribina, anti-CD4, irradiazione corporea totale, o trapianto del midollo osseo G.Qualsiasi agente immunosoppressivo, compresi, a titolo esemplificativo: mitoxantrone, azatioprina, ciclosporina, ciclofosfamide o tacrolimus. 7.Storia o presenza di effetti avversi significativi da un punto di vista medico (comprese reazioni allergiche) dovuti a: A.Cetirizina (o equivalente) B.Paracetamolo/acetaminofene C.Corticosteroidi. 8.Ipersensibilità nota a componenti del farmaco sperimentale. 9.Patologia maligna pregressa o attuale, ad eccezione di: A.Carcinoma cervicale di Stadio 1B o inferiore. B.Carcinoma basocelullare e carcinoma cutaneo a cellule squamose non invasivo C.Diagnosi di carcinoma con una durata della risposta completa (remissione) >5 anni D.L’anamnesi di patologia ematologica maligna esclude un soggetto dalla partecipazione, indipendentemente dalla risposta.10.Elettrocardiogramma (ECG) che mostra anormalità clinicamente significativa allo screening o che mostra un QTcB o intervallo QTcF medi >=450 msec (>=480 msec per soggetti con blocco di branca) su 3 ECG consecutivi. 11.Condizione medica concomitante significativa, non controllata, comprese, a titolo esemplificativo, patologia cardiaca, renale, epatica, ematologica, gastrointestinale, endocrina, sindrome da immunodeficienza, patologia polmonare, cerebrale, psichiatrica o neurologica che, a giudizio dello sperimentatore, potrebbe avere un impatto sulla sicurezza del soggetto, compromettere una partecipazione affidabile del soggetto allo studio, compromettere la valutazione degli endpoint o rendere necessario l’utilizzo di farmaci non consentiti da questo protocollo. 12.Anamnesi di trauma del SNC grave, clinicamente significativo (ad esempio, danno cerebrale traumatico, compressione del midollo spinale) o storia o presenza di mielopatia dovuta a compressione del midollo spinale per patologia discale o vertebrale. 13.Patologia infettiva cronica o attiva in corso che richieda trattamento sistemico a lungo termine come, a titolo esemplificativo, infezione renale cronica, infezione toracica cronica con bronchiectasia, tubercolosi o epatite C.

E.5 End points

E.5.1

Primary end point(s)

Cumulative number of new T1 gadolinium-enhancing brain lesions at Week 12 from Week 0 based on MRI scans at Weeks 4, 8, and 12

Numero cumulativo di nuove lesioni cerebrali T1 GdE alla Settimana 12 rispetto allo screening sulla base delle RMN alle Settimane 4, 8 e 12.

E.5.1.1

Timepoint(s) of evaluation of this end point

week 12

settimana 12

E.5.2

Secondary end point(s)

•Cumulative number of new T1 Gd-enhancing brain lesions at Week 24 from Week 0 based on MRI scans at Weeks 4, 8, 12, 16, 20, and 24. •Gd-enhancing brain lesions on T1-weighted MRI based on MRI scans at Weeks 4, 8, and 12: -Cumulative number of persistent lesions at Week 12 from Week 0; -Cumulative number of all lesions at Week 12 (new plus persistent) from Week 0; -Total volume of new lesions at Week 12 (relative to Week 0); -Total volume of all lesions (new plus persistent) •T2 lesions based on MRI scans from Week 0 to Weeks 4, 8, and 12: -Cumulative number of new and/or newly enlarging lesions at Week 12; -Volume of new and/or newly enlarging T2 lesions at Week 12 •T1 hypointense lesions: -Cumulative number of new T1 hypointense lesions at Week 24 and Week 48 from Week 0; -Change from baseline in volume of T1 hypointense lesions at Week 24 and Week 48 •Change from baseline in brain volume at Week 24 and Week 48.

•Numero cumulativo di nuove lesioni cerebrali T1 GdE alla Settimana 24 rispetto allo screening sulla base delle RMN alle Settimane 4, 8, 12, 16, 20 e 24 •Lesioni cerebrali captanti gadolinio sulla RMN T1-pesata sulla base delle RMN alle Settimane 4, 8 e 12: Numero cumulativo di lesioni persistenti alla Settimana 12 dallo screening; Numero cumulativo di tutte le lesioni alla Settimana 12 (nuove più persistenti) dallo screening; Volume totale delle nuove lesioni alla Settimana 12 (in relazione allo screening; Volume totale di tutte le lesioni (nuove più persistenti; •Lesioni T2 sulla base delle RMN dallo screening alle Settimane 4, 8 e 12: Numero cumulativo di lesioni nuove e/o in fase di espansione alla Settimana 12 Volume delle lesioni T2 nuove e/o di nuova espansione alla Settimana 12 •Lesioni T1 ipointense: Numero cumulativo di nuove lesioni T1 ipointense alla Settimana 24 e alla Settimana 48 dallo screening Variazione rispetto allo screening nel volume delle lesioni T1 ipointense alla Settimana 24 e alla Settimana 48 •Variazione rispetto allo screening nel volume cerebrale alla Settimana 24 e alla Settimana 48.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 12, Week 24, and/or Week 48

settimana 12, settimana 24 e/o settimana 48.

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

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)

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

Russian Federation

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

LVLS

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:

254

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

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

F.4.2.2

In the whole clinical trial

196

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)

Post-study treatment with ofatumumab will not be provided to subjects, as dose determination and full safety evaluation is required prior to exposing subjects for longer durations. Considerations for the post-study care of a subject’s medical conditions are the responsibility of the investigator.

Ai soggetti non sarà fornito il trattamento con ofatumumab dopo lo studio, perchè sono necessarie valutazinoi relative alla dose ed al profilo di sicurezza di ofatumumab prima di esporre i soggetti ad un tratamento più prolungato. E' responsabilità dello sperimentatore valutare la cura delle condizioni mediche del soggetto dopo lo studio.

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

2012-03-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-03-07

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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