Clinical Trials Register

Summary
EudraCT Number:	2010-020992-21
Sponsor's Protocol Code Number:	AB06012
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:	2012-05-28
Trial 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

2010-020992-21

A.3

Full title of the trial

Estudio prospectivo, Fase IIb/III, multicéntrico, randomizado, doble ciego, controlado, de 3 grupos paralelos y 24 semanas de duración con posible extensión, para comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4,5 mg/kg/día, con metotrexato, con randomización 1:1:1, en el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos

A.3.1

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

Comparación de la eficacia de masitinib frente a metotrexato en el tratamiento de la artritis reumatoide

A.3.2

Name or abbreviated title of the trial where available

AB1010 en tratamiento de pacientes con artritis reumatoide activa.

A.4.1

Sponsor's protocol code number

AB06012

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	AB Science
B.1.3.4	Country	France
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	AB Science
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AB Science
B.5.2	Functional name of contact point	Philippe Giorgiutti
B.5.3	Address:
B.5.3.1	Street Address	3 avenue George V
B.5.3.2	Town/ city	Paris
B.5.3.3	Post code	75008
B.5.3.4	Country	France
B.5.4	Telephone number	NANA0147206676NA
B.5.5	Fax number	NANA0147202411NA
B.5.6	E-mail	philippe.giorgiutti@ab-science.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	Masitinib
D.3.2	Product code	AB1010
D.3.4	Pharmaceutical form	Film-coated 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	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.9.3	Other descriptive name	No aplica
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	100
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	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	Masitinib
D.3.2	Product code	AB1010
D.3.4	Pharmaceutical form	Film-coated 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	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.9.3	Other descriptive name	no aplica
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	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: 3
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
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Aventis
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Methotrexate
D.3.2	Product code	no aplica
D.3.4	Pharmaceutical form	Capsule, hard
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.3.9.2	Current sponsor code	no aplica
D.3.9.3	Other descriptive name	no aplica
D.3.9.4	EV Substance Code	SUB08856MIG
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	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: 4
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	Masitinib
D.3.2	Product code	AB1010
D.3.4	Pharmaceutical form	Film-coated 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	masitinib mesylate
D.3.9.1	CAS number	790-299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.9.3	Other descriptive name	No aplica
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	100
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: 5
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	Masitinib
D.3.2	Product code	AB1010
D.3.4	Pharmaceutical form	Film-coated 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	masitinib mesylate
D.3.9.1	CAS number	790299-79-5
D.3.9.2	Current sponsor code	AB1010
D.3.9.3	Other descriptive name	No aplica
D.3.9.4	EV Substance Code	SUB32266
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	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.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	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 3
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Atritis Reumatoide

E.1.1.1

Medical condition in easily understood language

Artritis

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

Objetivos del estudio:
El objetivo es comparar la eficacia y seguridad de masitinib, a la dosis de 3 y 4.5 mg/kg/día, con metotrexato, con randomización 1:1:1, para el tratamiento de pacientes con artritis reumatoide activa y con una respuesta inadecuada a 1. metotrexato, a 2. cualquier FAME incluido al menos un fármaco biológico si previamente resultó ineficaz en pacientes tratados con metotrexato o a 3. metotrexato en combinación con cualquier FAME incluidos fármacos biológicos.

Objetivo principal:
? ACR20 en la semana 24.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Criterios de inclusión:
1. Pacientes con artritis reumatoide diagnosticada de acuerdo con los criterios del American College of Rheumatology (ACR) durante al menos 6 meses.
2. Pacientes con una clase funcional I-III del ACR.
3. Pacientes que presentan AR activa consistente en:
? ? 6 articulaciones inflamadas (de un total de 66 articulaciones inflamadas).
? ? 6 articulaciones con dolor a la palpación (de un total de 68 articulaciones con dolor a la palpación).
? Y al menos 2 de 3 de lo siguiente:
a. Velocidad de sedimentación globular (VSG/primera hora) ? 20 mm.
b. Proteína C-reactiva (PCR) ? 10 mg/l.
c. Rigidez matutina ? 45 minutos tanto en la selección como en la visita basal.
4. Los pacientes que no tuvieron resultados (definido como una AR activa con dosis estable durante 3 meses) con metotrexato o con cualquier FAME incluidos fármacos biológicos si antes no habían tenido resultados con metotrexato o con metotrexato en combinación con cualquier FAME incluidos fármacos biológicos (que se definen como cualquiera de los siguientes tratamientos: anti-TNF?, anti-CD20, anti-IL1, anti-IL6, CTLA4).
5. Pacientes en que la enfermedad apareció a una edad >16 años.
6. Pacientes con una actividad orgánica adecuada:
? Recuento absoluto de neutrófilos (RAN) ≥ 2 x 109/l
? Hemoglobina ≥ 10 g/dl
? Plaquetas ≥ 100 x 109/l
? ASAT/ALAT ≤ 2,5x LSN
? Bilirrubina ≤ 1,5x LSN
? Gamma GT ≤ 2,5 x LSN
? Aclaramiento de creatinina ≥ 50 ml/min (fórmula de Cockcroft y Gault)
? Albúmina > 1 x LIN
? Urea ≤ 1,5 x LSN
? Proteinuria < 30 mg/dl en tira reactiva; en caso de proteinuria ? 30 mg/dl, proteinuria de 24 horas < 1,5 g/24 horas
7. Pacientes de sexo masculino o femenino, de edad >18 años y peso superior a 49,9 kg y con un IMC< 35.
8. Paciente capaz de entender la tarjeta del paciente y seguir los procedimientos descritos en caso de signos y síntomas de neutropenia severa o toxicidad cutánea severa, durante los 2 primeros meses de tratamiento.
9. El o la paciente en edad de procrear (que participe en el estudio una vez pasado el periodo menstrual y con una prueba de embarazo negativa) debe acceder a utilizar dos métodos anticonceptivos aceptados médicamente (uno para el/la paciente y el otro para la pareja) durante el estudio y en los 6 meses a partir de la última toma del tratamiento.
10. Pacientes capaces y dispuestos a cumplir las visitas del estudio y los procedimientos definidos por protocolo.
11. Pacientes capaces de entender, firmar y fechar la hoja de consentimiento informado en la visita de selección antes de que se realice cualquier procedimiento especificado en el protocolo.

E.4

Principal exclusion criteria

Criterios de exclusión:
Un paciente no debe incluirse si cumple cualquiera de los siguientes criterios de exclusión:
1. Pacientes en que esté contraindicado el uso de metotrexato tal como se indica en el resumen de las características del producto (es decir, pacientes con insuficiencia renal o hepática grave, discrasia sanguínea preexistente, alcoholismo, infección aguda o crónica, intolerancia al metotrexato o en tratamiento con vacunas vivas atenuadas).
2. Pacientes con fibromialgia confirmada.
3. Pacientes sometidos a cirugía mayor en las 2 semanas anteriores a la entrada en el estudio.
4. Pacientes con intolerancia a la lactosa.
5. Pacientes con afecciones cardíacas definidas por al menos uno de los siguientes alteraciones:
 Pacientes con antecedentes cardíacos recientes (en los 6 meses previos) de:
o Síndrome coronario agudo.
o Insuficiencia cardíaca aguda (clase III o IV según la clasificación de la NYHA).
o Arritmia ventricular significativa (taquicardia ventricular persistente, fibrilación ventricular, muerte súbita reanimada).
 Pacientes con insuficiencia cardíaca de clase III o IV según la clasificación de la NYHA.
 Pacientes con alteraciones graves de la conducción cardíaca no evitables mediante electroestimulación cardíaca permanente (bloqueo auriculoventricular 2 y 3, bloqueo sinoauricular).
 Síncope sin etiología conocida en los 3 meses anteriores.
 Hipertensión grave no controlada, a juicio del investigador, o hipertensión sintomática.
6. Pacientes con una esperanza de vida < 6 meses.
7. Pacientes con antecedentes de tumor maligno primario < 5 años, excepto carcinoma basocelular de piel o carcinoma cervicouterino localizado tratados.
8. Pacientes con una enfermedad grave y/o no controlada.
9. Mujeres embarazadas o en periodo de lactancia.
10. Pacientes diagnosticados de infección por el virus de inmunodeficiencia humana (VIH).
11. Pacientes con antecedentes de pobre cumplimiento o abuso de drogas/alcohol, o consumo excesivo de bebidas alcohólicas o enfermedades psiquiátricas presentes o pasadas que pudieran interferir en su capacidad para cumplir el protocolo del estudio o para dar su consentimiento informado.
12. Pacientes previamente tratados con metrotrexato a dosis >20 mg no pueden ser incluidos en el estudio
Tratamientos anteriores:
13. Pacientes previamente tratados con un FAME (excepto metotrexato) en las 4 semanas previas a la selección (o 5 semividas, lo que sea más largo), excepto leflunomida que exige un periodo de lavado de 2 semanas antes de la selección e infliximab que exige un periodo de lavado de 8 semanas.
14. Pacientes tratados con más de un antiinflamatorio no esteroideo (AINE) o cambio de dosis de AINE en las 4 semanas previas a la selección o un uso de AINE superior a la dosis máxima recomendada.
15. Pacientes tratados con más de 10 mg/día de prednisona o equivalente o cambio en la dosis de prednisona o equivalente, o inyección intraarticular de corticoesteroides o bolo intramuscular o tratamiento intravenoso con corticoesteroides (>20 mg de prednisona o equivalente) en las 4 semanas previas a la selección.
16. Tratamiento con cualquier fármaco en fase de investigación en las 4 semanas previas a la selección.

E.5 End points

E.5.1

Primary end point(s)

? ACR20 en la semana 24.

E.5.1.1

Timepoint(s) of evaluation of this end point

24 semanas

E.5.2

Secondary end point(s)

 Evaluación de la respuesta:
o ACR20 en la semana 12.
o ACR en las semanas 12 y 24:
 ACR50
 ACR70
 ACR90
 ACRn
o Tiempo hasta la primera respuesta según ACR20 y ACR50.
o DAS28 en las semanas 12 y 24:
 DAS28 (escala de actividad de la enfermedad).
 DAS28 < 2,6 (remisión completa).
 DAS28 < 3,2 (actividad baja de la enfermedad).
o Nivel de PCR y VSG en las semanas 12 y 24:
 Valores de PCR y VSG.
 Porcentaje de pacientes con una mejoría de la PCR y VSG >50%, entre 25 y 50%, entre 0 y 25% o sin mejoría.
 Evaluación de la calidad de vida:
o Escala vidual de evaluación en las semanas 12 y 24 de:
 dolor
 astenia
 salud general
o Calidad de vida evaluada mediante el cuestionario SF36 en las semanas 12 y 24.
o Puntuación del cuestionario de evaluación de la salud HAQ en las semanas 12 y 24.
o Escala de Hamilton en las semanas 12 y 24.
o Escala de impacto de la fatiga en las semanas 12 y 24.
 Evaluaciones de la seguridad: acontecimientos adversos, constantes vitales, datos analíticos.

E.5.2.1

Timepoint(s) of evaluation of this end point

semanas 12 y 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

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

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

India

Thailand

Turkey

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

Tras 24 semanas en tratamiento, en caso de beneficio clínico, los pacientes pueden permanecer en el estudio recibiendo medicación

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

150

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

250

F.4.2.2

In the whole clinical trial

140

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)

INDIFERENTE

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

2011-10-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-06

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

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Orphan Designation Number:
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