Clinical Trials Register

Summary
EudraCT Number:	2005-002395-15
Sponsor's Protocol Code Number:	WA17047
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:	2006-03-02
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

2005-002395-15

A.3

Full title of the trial

A randomized, phase 3, controlled, double-blind, parallel-group, multicenter study to evaluate the safety and efficacy of rituximab in combination with methotrexate (MTX) compared to MTX alone, in methotrexate-naïve patients with active rheumatoid arthritis.

Studio multicentrico randomizzato, controllato, di fase III, in doppio cieco e a gruppi paralleli, per valutare la sicurezza e l efficacia di rituximab in associazione con methotrexate (MTX) rispetto a methotrexate (MTX) da solo, in pazienti con artrite reumatoide attiva naïve al MTX.

A.4.1

Sponsor's protocol code number

WA17047

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	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Viale G.B. Stucchi, 110
B.5.3.2	Town/ city	Monza
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	italy.info_cta@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	Yes
D.2.1.1.1	Trade name	METHOTREXATE*100CPR 2,5MG
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA *
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Methotrexate
D.3.9.1	CAS number	59-05-2
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	2.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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.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	METHOTREXATE*25CPR 2,5MG
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Methotrexate
D.3.9.1	CAS number	174722-31-7
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	2.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	No
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	Non Applicabile
D.IMP: 3
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	MabThera
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Limited
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 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	Rituximab
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.3	Concentration number	500
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	No
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 chimerico murino/umano

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

Rheumatoid Arthritis (RA)

Artrite Reumatoide (AR)

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	PT
E.1.2	Classification code	10039073
E.1.2	Term	Rheumatoid arthritis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue 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 the efficacy of rituximab in the prevention of progression in structural joint damage and to evaluate the safety of rituximab in patients with active rheumatoid arthritis initiating treatment with MTX.

Determinare l'efficacia di rituximab nella prevenzione della progressione del danno strutturale articolare e valutare la sicurezza di rituximab nei pazienti con artrite reumatoide attiva che iniziano il trattamento con MTX.

E.2.2

Secondary objectives of the trial

- To evaluate the efficacy of rituximab in improving patient s physical function and signs and symptoms of RA. - To investigate by a population analysis approach the pharmacokinetics (PK) of rituximab in the target RA patient population and the influence of covariates on the PK parameters. - To explore the long-term efficacy and safety of further courses of rituximab.

- Valutare l'efficacia di rituximab nel miglioramento della funzione fisica del paziente e dei segni e dei sintomi dell'AR.- Studiare mediante approccio di analisi di popolazione la farmacocinetica (PK) di rituximab nella popolazione di pazienti con AR e l'influenza di covariate sui parametri farmacocinetici.- Esplorare l'efficacia e la sicurezza a lungo termine di ulteriori cicli di rituximab.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

PHARMACOGENETIC:
Vers:WA17047RG
Date:2005/08/31
Title:
Objectives:

FARMACOGENETICA:
Vers:WA17047RG
Data:2005/08/31
Titolo:Progetto di Ricerca Roche per la conservazione dei Campioni in associazione con il protocollo WA17047
Obiettivi:Ottenere dai pazienti che hanno firmato il consenso e che partecipano al relativo studio WA17047 un unico campione di sangue per analisi farmacogenetiche e di ricerca genetica.

E.3

Principal inclusion criteria

1. Able and willing to give written informed consent and comply with the requirements of the study protocol. 2. Patients with rheumatoid arthritis diagnosed for at least 8 weeks prior to baseline, but no more than 4 years, according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis. 3. Patients naïve to, and considered to be candidates for, treatment with methotrexate. 4. Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) both at screening and baseline. 5. At screening CRP ≥ 1.0 mg/dL (10 mg/L). 6. Minimum age of 18 years. 7. Glucocorticoids ≤ 10 mg/day prednisolone or equivalent is permitted if stable for at least 4 weeks prior to baseline. 8. Use of NSAIDs is permitted if stable for at least 2 weeks prior to baseline. 9. For patients of reproductive potential (males and females), use of a reliable means of contraception (e.g. hormonal contraceptive, patch, intrauterine device, physical barrier) throughout study participation. 10. Must be willing to receive oral folate. 11. For RF negative patients only, radiographic evidence of at least one joint with definite erosion attributable to RA. 12. Patients who are to receive, or who are currently receiving, treatment for RA on an outpatient basis.

1.Pazienti in grado di capire e firmare il consenso informato e di rispettare le procedure richieste dallo studio. 2.Pazienti con AR da almeno 8 settimane, ma non piu` di 4 anni, diagnosticata secondo i criteri dell American College of Rheumatology (ACR) del 1987. 3.Pazienti naïve al MTX e candidati per una terapia con MTX. 4.Conta delle articolazioni tumefatte (SJC) ≥ 8 (su 66 articolazioni) e conta delle articolazioni dolenti (TJC) ≥ 8 (su 68 articolazioni) allo screening e al basale. 5.Proteina C reattiva (CRP) ≥ 1.0 mg/dL (10 mg/L) allo screening. 6.Almeno 18 anni. 7.Sono consentiti corticosteroidi orali (prednisone o equivalente ≤ 10 mg/die) purche` a dosaggio stabile da almeno 4 settimane prima del basale. 8.Sono consentiti FANS purche` a dosaggio stabile da almeno 2 settimane prima del basale. 9.Donne in eta` fertile e uomini con una compagna in eta` fertile possono partecipare allo studio soltanto se utilizzano un metodo contraccettivo affidabile (es. pillola, cerotto, spirale, barriera fisica) durante l intera durata dello studio. 10.Pazienti intenzionati a ricevere folato orale. 11.Pazienti FR-negativi con evidenza radiografica di almeno un erosione attribuibile ad AR, in base a una lettura centralizzata. 12.Pazienti che devono ricevere o stanno ricevendo al momento trattamenti ambulatoriali per AR.

E.4

Principal exclusion criteria

Exclusions Related to RA 1. Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty s syndrome). Secondary Sjögren s syndrome or secondary limited cutaneous vasculitis with RA is permitted. 2. Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis. 3. History of, or current, inflammatory joint disease other than RA (including, but not limited to, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome). 4. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before age 16.5. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned during the study. 6. Lack of peripheral venous access. 7. Pregnancy or breast feeding. 8. Significant and/or uncontrolled cardiac or pulmonary disease (including obstructive pulmonary disease). 9. Evidence of significant concomitant disease, including but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator s opinion, would preclude patient participation. 10. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection. 11. Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with i.v. anti-infectives within 4 weeks of baseline or completion of oral anti-infectives within 2 weeks prior to baseline. 12. History of deep space/tissue infection (e.g. fasciitis, abscess, osteomyelitis) within 52 weeks prior to baseline. 13. History of serious recurrent or chronic infection (for screening for a chest infection a chest radiograph will be performed at screening if not performed within 12 weeks prior to screening). 14. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured). 15. Any neurological (congenital or acquired), vascular or systemic disorder which could affect any of the efficacy assessments, in particular, joint pain and swelling (e.g. Parkinson s disease, cerebral palsy, diabetic neuropathy). 16. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to baseline Exclusions Related to Medications 17. History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of rituximab or to murine proteins. 18. Previous treatment with any approved or investigational biologic agent for RA. 19. Previous treatment with an anti-alpha 4 integrin antibody or co-stimulation modulator. 20. Concurrent treatment with any biologic agent or DMARD other than MTX. Treatment must be discontinued 14 days prior to baseline, except for the following: azathioprine for ≥ 28 days; leflunomide for ≥ 8 weeks (or ≥ 14 days after 11 days of standard cholestyramine or activated charcoal washout). Et al..

Esclusione correlata ad AR 1.Malattia reumatica autoimmune diversa dall AR, o significativo coinvolgimento sistemico secondario all AR (incluso ma non limitato a vasculiti, fibrosi polmonare o sindrome di Felty). La concomitanza della sindrome di Sjögren secondaria o vasculite cutanea circoscritta secondaria ad AR sono accettate. 2.Appartenenza alla IV classe di capacita` funzionale (criteri ACR di classificazione). 3.Precedente anamnesi, o attuale malattia articolare infiammatoria diversa da AR (incluso, ma non limitato a gotta, artrite reattiva, artrite psoriasica, spondiloartropatia sieronegativa, malattia di Lyme) o altri disordini sistemici (incluso, ma non limitati a lupus erimatoso sistemico, malattia infiammatoria cronica dell intestino, scleroderma, miopatia infiammatoria, connettivite mista o ogni sindrome da sovrapposizione). 4.Diagnosi di artrite idiopatica giovanile (JIA) o di artrite reumatoide giovanile (JRA) e/o AR prima dei 16 anni. Esclusione correlate allo stato di salute 5.Procedure chirurgiche, incluso chirurgia/sinovectomia ossea/articolare (incluso fusione o sostituzione articolare) nelle 12 settimane precedenti il basale o pianificate durante lo studio. 6.Difficolta` all accesso venoso periferico. 7.Gravidanza o stato di allattamento. 8.Evidenza di patologia cardiaca o polmonare severa e/o non controllata (inclusa malattia polmonare ostruttiva). 9.Evidenza di severa patologia concomitante inclusa, ma non limitata al sistema nervoso, renale, epatico, endocrino o gastrointestinale, che a giudizio dello sperimentatore, potrebbe precludere la partecipazione del paziente allo studio. 10.Immunodeficienza primaria o secondaria (precedenti od allo stato attuale), inclusa anamnesi di infezione da HIV. 11.Ogni tipo di infezione attiva nota (con esclusione delle infezioni micotiche del letto ungueale), o qualsiasi episodio importante di infezione per cui e` necessaria una ospedalizzazione od una terapia endovena con antibiotici entro le 4 settimane precedenti lo screening oppure una terapia con antibiotici orali, completata nelle 2 settimane precedenti il basale. 12.Storia di infezioni tissutali profonde (es. fasciti, ascessi, osteomieliti) entro le 52 settimane prima del basale. 13.Storia di infezioni serie ricorrenti o croniche (per escludere infezioni al torace, allo screening sara` effettuata una radiografia toracica, se non gia` effettuata nelle 12 settimane precedenti lo screening). 14.Storia di neoplasie, inclusi tumori solidi, neoplasie ematologiche e carcinoma in situ (eccetto il carcinoma della cute a cellule basali gia` asportato e guarito). 15.Disordini neurologici (congeniti o acquisiti), vascolari o sistemici che possono interferire con gli accertamenti di efficacia, in particolare, dolore articolare e tumefazione (es. Parkinson, paralisi cerebrale, neuropatia diabetica). 16.Anamnesi attuale o storia di abuso di alcohol o droga nelle 24 settimane prima del basale. Esclusione correlate a terapie precedenti e/o concomitanti 17.Anamnesi di reazioni allergiche severe o anafilattiche verso agenti biologici o ipersensibilita` nota verso alcuni componenti di rituximab o verso proteine murine. 18.Trattamento precedente con un qualsiasi agente biologico approvato o in sperimentazione per l AR. 19.Precedente trattamento con un anticorpo anti integrina alpha-4 o un modulatore della co-stimolazione. 20.Concomitante trattamento con un qualsiasi agente biologico o DMARD diverso dal MTX. Il trattamento deve essere interrotto 14 giorni prima del basale, ad eccezione dei seguenti trattamenti: azatioprina ≥ 28 giorni; leflunomide ≥ 8 settimane (o ≥14 giorni dopo 11 giorni di wash-out con colestiramina standard o carbone attivato). E altri..

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is the change from screening in total modified Sharp score at Week 52 using the modified ITT population.

L obiettivo primario e` la variazione nel punteggio totale di Sharp modificato dallo screening alla settimana 52 usando la popolazione ITT (Intent To Treat) modificata.

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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

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

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

La fine del trattamento e` la settimana 248 o il 31 Dicembre 2011 (a seconda di quale delle due scadenze sia la piu` prossima) e a seguire ci sara` un ulteriore periodo di almeno 1 anno di safety follow up.

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	No
F.1.1	Number of subjects for this age range:	0
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	56
F.4.2	For a multinational trial
F.4.2.1	In the EEA	240
F.4.2.2	In the whole clinical trial	750

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

2005-12-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2005-11-07

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-07-22

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