Clinical Trials Register

Summary
EudraCT Number:	2010-022378-15
Sponsor's Protocol Code Number:	VT-4001-001-SP
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2011-02-21
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

Spain - AEMPS

A.2

EudraCT number

2010-022378-15

A.3

Full title of the trial

VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate.

VELVET (ensayo exploratorio de diversas dosis de veltuzumab), ensayo multinacional, multicéntrico, en fase II, aleatorizado, doble ciego y controlado con placebo de determinación del intervalo de dosis en pacientes con artritis reumatoide entre moderada y grave, controlada de manera insuficiente con metotrexato en monoterapia o metotrexato más tratamiento biológico contra el factor de necrosis tumoral, para comparar tres dosis subcutáneas diferentes del anticuerpo monoclonal anti-CD20, veltuzumab, con placebo como tratamiento complementario de metotrexato

A.3.1

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

A clinical study to explore the therapeutic effects of different doses of
the new drug veltuzumab, a drug of biologic origin, and placebo, in
patients with rheumatoid arthritis.

Estudio clínico para explorar los efectos terapéuticos de diferentes dosis de un nuevo fármaco llamado veltuzumba, un fármaco de origen biológico, y placebo, en pacientes con artritis reumatoide.

A.3.2

Name or abbreviated title of the trial where available

VELVET

A.4.1

Sponsor's protocol code number

VT-4001-001-SP

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	Nycomed GmbH
B.1.3.4	Country	Germany
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	Nycomed GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Nycomed GmbH
B.5.2	Functional name of contact point	Clinical trial operations
B.5.3	Address:
B.5.3.1	Street Address	Byk-Gulden-Strasse 2
B.5.3.2	Town/ city	Konstanz
B.5.3.3	Post code	78467
B.5.3.4	Country	Germany
B.5.4	Telephone number	00497531844634
B.5.5	Fax number	00497531844634
B.5.6	E-mail	uwe.ramsperger@nycomed.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	Veltuzumab solution 75mg/ml
D.3.2	Product code	hA20 (Immu-106)
D.3.4	Pharmaceutical form	Solution for injection
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	Veltuzumab
D.3.9.1	CAS number	728917-18-8
D.3.9.2	Current sponsor code	hA20, IMMU-106
D.3.9.3	Other descriptive name	humanised anti-CD 20 antibody
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	70 to 80
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)	Yes
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.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

Rheumatoid Arthritis

Artritis reumatoude

E.1.1.1

Medical condition in easily understood language

Chronic autoimmune disease that causes inflammation and deformity of
the joints

Enfermedad autoinmune crónica que causa inflamación y deformidad en las articulaciones.

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
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 investigate the efficacy and safety of three different sc doses of the
humanized anti-CD20 antibody veltuzumab as an add-on treatment to
MTX over 24 weeks compared to MTX alone

Investigar la eficacia, la seguridad y la tolerabilidad en la semana 24 de tres niveles de dosis s.c. diferentes del anticuerpo anti-CD20 humanizado veltuzumab como tratamiento complementario de MTX en comparación con MTX en monoterapia en pacientes con AR entre moderada y grave

E.2.2

Secondary objectives of the trial

To identify the dosage(s) of veltuzumab with the most favourable
benefit-risk-ratio to be further evaluated in the subsequent Phase II/III
clinical program in patients with moderate to severe RA

Identificar la posología de veltuzumab con el perfil más favorable de riesgos y beneficios para su evaluación más exhaustiva en el programa clínico en fase II/III posterior en pacientes con AR entre moderada y grave.

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

Nested pharmacokinetic and exploratory biomarker study in a subset of
60 patients

Estudio de evaluaciones farmacocinéticas y biomarcadores exploratorios en un subgrupo de 60 pacientes.

E.3

Principal inclusion criteria

- Written informed consent obtained before any trial-related activities
- Outpatient, male or female, at least 18 years of age at Screening
- Active rheumatoid arthritis. Diagnosis of RA using the ACR criteria for
the classification of RA for at least 6 months prior to trial entry (based
on swollen and tender joint count; CRP and/or ESR; RF and/or anti-CCP)
- An inadequate response to previous or current treatment with either
MTX alone or a combination of MTX plus anti-tumor necrosis factor alpha
biologic agents.
- Receiving MTX 15-25 mg/week (oral or parenteral) for at least 20
weeks, including the last 6 weeks prior to Baseline at a stable dose
- Subjects of reproductive potential (females and males) must agree to
use effective double-method contraception
- Female subjects must not be actively breast-feeding

Consentimiento informado por escrito obtenido de acuerdo con las normativas locales antes de realizar
ninguna actividad relacionada con el ensayo Paciente ambulatorio, de cualquier sexo y de al menos 18
años de edad en la selección (visita 1). Enfermedad activa definida como: *Diagnóstico de AR, según
los criterios del ACR para la clasificación de la AR, durante al menos 6 meses antes de la incorporación
al ensayo (selección, visita 1) *Número de articulaciones inflamadas (NAI) 6 y número de
articulaciones dolorosas (NAD) 6 según el sistema de recuento articular de 66/68 articulaciones.
*Proteína C reactiva de alta sensibilidad (PCR-as) 15 mg/l o velocidad de sedimentación globular
(VSG) 28 mm/hora. *Factor reumatoide (FR) positivo 14 UI/ml o anticuerpos antiproteína citrulinada
cíclica (PCC) 20 U Respuesta insuficiente al tratamiento previo o actual con MTX en monoterapia o
MTX combinado con tratamiento biológico frente al factor de necrosis tumoral alfa. Recepción de MTX
15 25 mg/semana (oral o parenteral) durante al menos 20 semanas, incluidas las 6 semanas previas al
período basal (visita 3, día 1) en una dosis estable . Los pacientes con capacidad reproductiva (de ambos
sexos) deberán comprometerse a utilizar un método anticonceptivo doble. Las mujeres no deben amamantar.

E.4

Principal exclusion criteria

Medical history/concurrent diseases
Joints
- Subjects who are wheel chair or bed bound
- Rheumatic autoimmune disease other than RA, or significant systemic
involvement secondary to RA
- History of or current inflammatory joint disease other than RA
- Septic prosthetic joint within the last 48 weeks prior to Baseline or
indefinitely if the prosthesis concerned remains in situ.
Infectious diseases
- Primary or secondary immunodeficiency, including human
immunodeficiency virus (HIV) infection
- Evidence of acute or chronic infection with hepatitis B virus (HBV) or
hepatitis C virus (HCV)
- Evidence and/or history of active tuberculosis (TB), prior to
successfully completing an anti-TB treatment. Subjects with latent TB
infection (LTBI) can be included
- Acute clinical manifestations of herpes zoster virus and history of
severe herpes zoster
- History of active infection of any kind or any major episode of infection
requiring hospitalisation or treatment with iv anti infective agents within
6 weeks prior to Baseline or oral anti-infective agents within 2 weeks
prior to Baseline
- History of deep space/tissue infection within 48 weeks prior to
Baseline
- History of osteomyelitis
- History of sepsis of any origin requiring intensive care
- History of serious recurrent or chronic infections not specified above.
Cardio-pulmonary
- Any significant cardiac disease
- History of severe chronic obstructive pulmonary disease (COPD)
and/or history of severe COPD exacerbation(s) within the last 12
months prior to Screening .
Immune system/haematology/biochemistry
- History of a severe allergic reaction or anaphylactic reaction to a
biological agent or history of hypersensitivity to any component of
veltuzumab injection solution
- Subjects with CD4 cell counts (< 250/?l) at Screening
- Hypogammaglobulinemia (IgG < 5.0 g/L, and/or IgM < 0.20 g/L) at
Screening
- Splenectomy
- Subjects with haemoglobin < 9.0 g/dL, white blood cell (WBC) count <
3000 cells/?L, absolute neutrophil count (ANC) < 2000 cells/?L,
lymphocyte count < 800 cells/?L or platelet count < 100,000/?L at
Screening
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT),
gamma-glutamyl transpeptidase (GGT) or alkaline phosphatase levels >
2.0 times the upper limit of normal (ULNR) at Screening
- Subjects with a serum creatinine > ULNR (e.g. > 1.2 mg/dL for males
and > 1.0 mg/dL for females) at Screening
Other medical conditions
- Subjects with diabetes mellitus type 1 or unstable type 2
- History of solid-organ transplantation
- History of cancer within the last 5 years treated with anti-cancer
chemotherapy
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- Current active alcohol or drug abuse or history of alcohol or drug abuse
within 24 weeks prior to Baseline. Opiate-containing medicines are not
allowed
- Evidence of any significant and/or unstable concomitant diseases such
as nervous system, renal, hepatic, endocrine, respiratory or
gastrointestinal disorders which, in the Investigator's opinion, would
preclude subject participation
- Any other medical condition (e.g. clinically relevant abnormal
laboratory values) that would, in the Investigator's opinion, make the
administration of trial drug or trial procedures hazardous to the subject,
or obscure the interpretation of AEs.
Skin
- Chronic skin ulcerations.
Previous and concomitant therapies and procedures
- Any planned, elective or emergency surgical procedure, including bone
or joint surgery/synovectomy within 12 weeks prior to or planned within
52 weeks after Baseline
- Treatment with any investigational agent 12 weeks or five half-lives of
the investigational drug or the duration of that agent's PD effect
(whichever is longer) prior to Baseline
- Previous treatment with any cell-depleting therapies, including
investigational agents
- Persistent urinary catheter or regular intermittent catheterisation
Other
- Previous participation in this clinical trial
- Pregnancy
- Donation or loss of more than 400 mL of blood within less than 3
months before first IMP administration
- History of MTX toxicity (especially pulmonary, hepatic or haematologic
toxicity) and unable to tolerate a stable dose of at least 12.5 mg/week
- Lack of peripheral venous access
- Employee at the investigational site, relatives or spouse of site staff
- Suspected inability, e.g. language problems, or unwillingness to comply
with trial procedures
- Subjects enrolled in this trial will not be allowed to donate blood, germ
cells, organs, or bone marrow during the trial and for at least 12 months
after the last administration of the IMP
E.5

Articulaciones:Pacientes en silla de ruedas o encamados.Enfermedad reumatológica autoinmunitaria distinta de la AR o afectación sistémica significativa secundaria a la AR. Antecedentes o presencia de una artropatía inflamatoria distinta de la AR u otro trastorno autoinmunitario sistémico. Prótesis articular séptica en las 48 semanas previas al período basal o indefinidamente si la prótesis afectada sigue colocada.Enfermedades infecciosas:(Antecedentes o presencia activa) Inmunodeficiencia primaria o secundaria, incluida la infección por VIH (se acepta una serología negativa del VIH hasta 3 meses antes del período basal).Signos de infección aguda o crónica por el virus de la hepatitis B, como la presencia de HBsAg, HBeAg o anticuerpos anti-HBc en suero. Signos de infección aguda o crónica por el virus de la hepatitis C. Signos o antecedentes de tuberculosis activa antes de la finalización satisfactoria de un tratamiento contra la TB. Podrá incluirse a los pacientes con infección tuberculosa latente. Manifestaciones clínicas agudas de una infección por el virus del herpes zóster y antecedentes de herpes zóster grave, definido como la afectación de más de un dermatoma, afectación ocular o necesidad de ingreso. Antecedentes de infección activa de cualquier tipo (excepto micosis del lecho ungueal) o cualquier episodio importante de infección con necesidad de hospitalización o tratamiento con medicamentos antiinfecciosos por vía i.v. en las 6 semanas previas al período basal o por vía oral en las 2 semanas previas al período basal. Antecedentes de infección de espacios/tejidos profundos en las 48 semanas previas al período basal. Antecedentes de osteomielitis. Antecedentes de septicemia de cualquier origen con necesidad de cuidados intensivos. Antecedentes de infecciones recurrentes o crónicas graves no especificadas anteriormente. Sistema cardiorrespiratorio: Cualquier cardiopatía significativa. Antecedentes de EPOC grave o antecedentes de exacerbaciones graves de la EPOC en los 12 meses previos a la selección. Sistema inmunitario/hematología/bioquímica: Antecedentes de reacción alérgica grave o reacción anafiláctica a un medicamento biológico o de hipersensibilidad a algún componente de la solución inyectable de veltuzumab. Pacientes con un recuento de linfocitos CD4 < 250/µl en la selección. Hipogammaglobulinemia (IgG < 5,0 g/l o IgM < 0,20 g/l) en la selección. Esplenectomía. Pacientes con hemoglobina < 9,0 g/dl, recuento de leucocitos < 3.000/µl, recuento absoluto de neutrófilos (RAN) < 2.000/µl, recuento de linfocitos < 800/µl o recuento de plaquetas < 100.000/µl en la selección). Concentraciones de AST, ALT, GGT o fosfatasa alcalina > 2,0 veces el límite LSN en la selección. Pacientes con una concentración sérica de creatinina > LSN.
Otras afecciones médicas: Pacientes con diabetes mellitus de tipo 1 o 2 inestable. Antecedentes de trasplante de órgano sólido. Antecedentes de cáncer en los últimos 5 años tratado con quimioterapia antineoplásica, incluidos tumores sólidos, neoplasias hematológicas malignas y carcinomas in situ (excepto los carcinomas basocelulares y espinocelulares de piel y el carcinoma in situ de cuello uterino que se han extirpado y curado). Alcoholismo o drogadicción activos actuales o antecedentes de ellos en las 24 semanas previas al período basal. Signos de cualquier enfermedad concomitante significativa o inestable, como trastornos del SN, renales, hepáticos, endocrinos, respiratorios o digestivos que, en opinión del investigador, imposibilitarían la participación del paciente. Cualquier otra afección médica que, en opinión del investigador, haría que la administración del medicamento o la realización de los procedimientos del estudio supusiera un peligro para el paciente o dificultara la interpretación de AA. Pie: Úlceras cutáneas crónicas.
Tratamientos y procedimientos previos y concomitantes: Cualquier procedimiento quirúrgico previsto, programado o de urgencia, incluida la cirugía articular u ósea y la sinovectomía (incluidas artrodesis y artroplastias), en las 12 semanas previas al período basal o previsto en las 52 semanas posteriores. Tratamiento con cualquier medicamento en investigación durante 12 semanas, 5 semividas del medicamento o la duración del efecto FD de dicho medicamento (lo que sea más prolongado) antes del período basal. Tratamiento previo con cualquier terapia citorreductora, incluidos medicamentos en investigación. Sonda urinaria permanente o intermitente. Otros: Participación previa en este ensayo. Embarazo. Donación o pérdida superior a 400 ml de sangre en los 3 meses previos a la primera admon. Antecedentes de toxicidad por MTX e incapacidad de tolerar una dosis estable de al menos 12,5 mg/sem. Falta de acceso venoso periférico. Empleado en el centro o familiar o cónyuge de un miembro del personal. Sospecha de incapacidad.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy variable will be the ACR20 responder rate after 24
weeks of double blind treatment with the study medication. Responders
will be defined as those whose improvement from baseline to endpoint
fullfil the following criteria:
- more or equal to 20% reduction in the TJC (66/68)
- more or equal to 20% reduction in the SJC (66/68)
- more or equal to 20% reduction in three of the following additional
measures:
- Subject assessment of pain (visual analogue scale [VAS])
- Subject global assessment of disease activity (VAS)
- Physician global assessment of disease activity (VAS)
- Degree of disability (HAQ-DI)
- Level of acute-phase reactant (CRP)

La variable principal de la eficacia será la tasa de respuesta ACR20 en la semana 24. Los pacientes con respuesta se definirán como aquellos cuya mejoría entre el período basal y el momento final cumpla los criterios siguientes:
20% de reducción del NAD (66/68)
20% de reducción del NAI (66/68)
20% de reducción en tres de las variables adicionales siguientes:
Evaluación del dolor por parte del paciente (EAV)
Evaluación global de la actividad de la enfermedad por parte del paciente (EAV)
Evaluación global de la actividad de la enfermedad por parte del médico (EAV)
Grado de discapacidad (HAQ-DI)
Concentración de reactantes de fase aguda (PCR).

E.5.1.1

Timepoint(s) of evaluation of this end point

Week 24

Semana 24

E.5.2

Secondary end point(s)

ACR20 response rate at week 48, ACR50 and ACR70 response rate at
week 24 and 48. Major clinical response. Safety parameters,
Pharmacokinetic parameters, Pharmacodynamic/Exploratory
biomarkers.

Tasa de respuesta ACR20 en la semana 88, ACR50 y ACR70 en la semana 24 y 48. Respuesta clínica importante. Parámetros de seguridad, parámetros farmacocinéticos, biomarcadores farmacodinámicos y exploratorios.

E.5.2.1

Timepoint(s) of evaluation of this end point

Various times points

Varios puntos en el tiempo

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

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

Argentina

Canada

Mexico

United States

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

last patient last visit (after 48 weeks)

última visita del último paciente (después de 48 semanas)

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.1.1.1

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:

210

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

200

F.4.2.2

In the whole clinical trial

300

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)

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

2011-05-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-12

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Clinical trials