Clinical Trials Register

Summary
EudraCT Number:	2014-004704-29
Sponsor's Protocol Code Number:	20140111
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-08-05
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

2014-004704-29

A.3

Full title of the trial

A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects with Moderate to Severe Rheumatoid Arthritis

Estudio en fase III, aleatorizado y con doble enmascaramiento para evaluar la eficacia y la seguridad de ABP 710 en comparación con infliximab en sujetos con artritis reumatoide de moderada a grave

A.3.1

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

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA).
This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.

Este ensayo ha sido diseñado para determinar los efectos del cuerpo humano sobre el fármaco experimental, ABP 710, así como los efecto del cuerpo sobre el fármaco en investigación después de haberlo administrado, y verificar si son comparables a los efectos observados con el fármaco aprobado, infliximab, en pacientes con artritis reumatoide (AR) de moderada a grave.

A.3.2

Name or abbreviated title of the trial where available

Not applicable

A.4.1

Sponsor's protocol code number

20140111

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	Amgen Inc.
B.1.3.4	Country	United States
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	Amgen Inc.
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	Amgen (EUROPE) GmbH
B.5.2	Functional name of contact point	IHQ Medical Info-Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Dammstrasse 23, PO Box 1557
B.5.3.2	Town/ city	Zug
B.5.3.3	Post code	CH-6300
B.5.3.4	Country	Switzerland
B.5.6	E-mail	Medinfointernational@amgen.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	ABP 710
D.3.2	Product code	ABP 710
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	ABP 710
D.3.9.2	Current sponsor code	ABP 710
D.3.9.3	Other descriptive name	ABP 710 - Biosimilar to infliximab
D.3.9.4	EV Substance Code	SUB182296
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	10
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.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	Remicade
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen Biotech, Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	infliximab
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	INFLIXIMAB
D.3.9.1	CAS number	170277-31-3
D.3.9.4	EV Substance Code	SUB02681MIG
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	10
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

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 reumatoide

E.1.1.1

Medical condition in easily understood language

Rheumatoid arthritis

artritis reumatoide

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	19.0
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

The primary objective for this study is to assess the efficacy of ABP 710 compared with US-licensed infliximab (infliximab).

El objetivo principal de este estudio es evaluar la eficacia de ABP 710 en comparación con el infliximab autorizado en los EE.UU. (infliximab).

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess the safety and immunogenicity of ABP 710 compared with infliximab.

Los objetivos secundarios son evaluar la seguridad y la inmunogenicidad de ABP 710 en comparación con infliximab.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Subject (man or woman) is ≥ 18 and ≤ 80 years old.
2.Subject is diagnosed with RA as determined by meeting the the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA.
3.Subject has RA duration of at least 3 months.
4.Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least 1 of the following at screening:
-erythrocyte sedimentation rate ≥ 28 mm/hr
-serum C-reactive protein > 1.0 mg/dL
5.Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening.
6.Subject has taken MTX for ≥ 12 consecutive weeks and is on a stable dose of oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receiving the investigational product and is willing to remain on a stable dose throughout the study.
7.For a subject on nonsteroidal anti-inflammatory drugs or low potency analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be stable for ≥ 2 weeks before screening.
8.For a subject on oral corticosteroids (≤ 10 mg prednisone or equivalent), the dose should be stable for ≥ 4 weeks before screening.
9.Subject has no known history of active tuberculosis.
10.Subject has a negative test for tuberculosis during screening defined as either:
-negative purified protein derivative (PPD) defined as < 5 mm of induration at 48 to 72 hours after test is placed
OR
-negative Quantiferon test
11.Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is allowed with a negative Quantiferon test.
12.Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed if they have all of the following:
-no symptoms of tuberculosis according to the worksheet provided by the sponsor, Amgen Inc.
-documented history of adequate prophylaxis initiation before receiving investigational product in accordance with local recommendations
-no known exposure to a case of active tuberculosis after most recent prophylaxis

1. El sujeto (varón o mujer) debe tener entre 18 y 80 años de edad, ambos inclusive.
2. El sujeto debe tener un diagnóstico de AR, determinado por el cumplimiento de los criterios para la clasificación de la AR de 2010 del Colegio Americano de Reumatología (American College of Rheumatology, ACR)/la Liga Europea contra el Reumatismo.
3. La AR del sujeto debe haber durado como mínimo 3 meses.
4. El sujeto debe tener AR activa, definida como ≥6 articulaciones inflamadas y ≥6 articulaciones sensibles (sobre la base del recuento de 66/68 articulaciones, excluidas las interfalángicas distales), en el momento de la selección y el inicio del estudio y como mínimo 1 de los siguientes valores en la selección:
- tasa de sedimentación de eritrocitos ≥28 mm/h
- proteína C reactiva en suero >1,0 mg/dl
5. El sujeto debe ser positivo para el factor reumatoide o los anticuerpos contra el péptido citrulinado cíclico en el momento de la selección.
6. El sujeto debe haber tomado MTX durante ≥12 semanas consecutivas y haber recibido por vía oral o subcutánea una dosis estable de entre 7,5 y 25 mg/semana de MTX durante ≥8 semanas antes de recibir el producto en investigación, y debe estar dispuesto a mantener la dosis estable durante todo el estudio.
7. Si el sujeto recibe antiinflamatorios no esteroideos o analgésicos de baja potencia como tramadol, compuestos Soma, fioricet o fiorinal, la dosis debe haber permanecido estable durante ≥2 semanas antes de la selección.
8. Si el sujeto recibe corticosteroides (≤10 mg de prednisona o equivalente), la dosis debe haber permanecido estable durante ≥4 semanas antes de la selección.
9. El sujeto no debe tener antecedentes conocidos de tuberculosis activa.
10. El sujeto debe hacerse durante la selección una prueba de tuberculosis con resultado negativo, definido como:
- derivado proteico purificado (DPP) negativo, definido como <5 mm de induración entre 48 y 72 horas después de realizar la prueba
O
- prueba de Quantiferon negativa
11. Se permite la participación de los sujetos con DPP positivo y antecedentes de vacunación con bacilo Calmette-Guérin si tienen una prueba de Quantiferon negativa.
12. Se permite la participación de los sujetos con DPP positivo (sin antecedentes de vacunación con bacilo Calmette-Guérin) o de los sujetos con una prueba de Quantiferon positiva o indeterminada si cumplen todos los requisitos siguientes:
- ausencia de síntomas de tuberculosis según la ficha facilitada por el promotor, Amgen Inc.
- antecedentes documentados de inicio de una profilaxis adecuada antes de recibir el producto en investigación conforme a las recomendaciones locales
- ausencia de exposición conocida a un caso de tuberculosis activa después de la profilaxis más reciente

E.4

Principal exclusion criteria

1.Subject has a history of prosthetic or native joint infection.
2.Subject has an active infection or history of infections as follows:
-any active infection for which systemic anti-infectives were used within 28 days before first dose of investigational product
-a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infective(s) within 8 weeks before the first dose of investigational product
-recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject
3.Subject has a positive blood test for human immunodeficiency virus.
4.Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody result at screening.
5.Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate or severe heart failure (New York Heart Association Class III/IV), renal disease, liver disease, or hypertension.
6.Subject had a malignancy within 5 years EXCEPT for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma.
7.Subject has a history of neurologic symptoms suggestive of central or peripheral nervous system demyelinating disease.
8.Subject has a major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren’s syndrome.
9.Subject has a concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
10.Subject has laboratory abnormalities at screening, including any of the following:
-hemoglobin < 9 g/dL
-platelet count < 100 000/mm3
-white blood cell count < 3 000/mm3
-aspartate aminotransferase and/or alanine aminotransferase ≥ 2.0 x the upper limit of normal
-creatinine clearance < 50 mL/min (Cockroft-Gault formula)
-any other laboratory abnormality, that, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results.
11.Subject has used commercially available or investigational biologic therapies for RA as follows:
-anakinra, etanercept within 1 month before the first dose of investigational product
-abatacept, tocilizumab, adalimumab, golimumab, certolizumab within 3 months before the first dose of investigational product
-other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) before the first dose of investigational product
-rituximab within 9 months before the investigational product along with evidence of incomplete B cell recovery
12.Subject has received live vaccines within 28 days before the first dose of investigational product or plans to receive live vaccines during the course of the study.
13.Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab.
14.Woman who is pregnant or breast feeding, or plans to become pregnant while enrolled in the study and for 6 months after the last dose of investigational product.
15.Woman who is of childbearing potential (ie, neither surgically sterile nor postmenopausal) and does not agree to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera® [medroxyprogesterone] injections, or contraceptive implants) while on study and for 6 months after the last dose of investigational product.

1.Antecedentes de infección articular protésica o nativa.
2.Infección activa o antecedentes de infección según lo siguiente:
- cualquier infección activa para la que se hayan utilizado antiinfecciosos sistémicos en los 28 días anteriores a la primera dosis del producto en investigación
- una infección grave, definida como la que requiere hospitalización o el uso de antiinfecciosos intravenosos (IV), en las 8 semanas anteriores a la primera dosis del producto en investigación
- infecciones recurrentes o crónicas u otra infección activa que, en opinión del investigador, podría hacer que este estudio fuera perjudicial para el sujeto
3. Análisis de sangre con resultado positivo para el virus de inmunodeficiencia humana.
4.Resultado positivo en las pruebas de antígeno de superficie de la hepatitis B, de anticuerpos contra el antígeno central de la hepatitis B o de anticuerpos contra el virus de la hepatitis C en el momento de la selección.
5.Enfermedad sistémica clínicamente significativa y no controlada, como diabetes mellitus, enfermedad cardiovascular, incluida la insuficiencia cardíaca moderada o grave (clase III/IV de la Asociación del Corazón de Nueva York [New York Heart Association]), enfermedad renal, enfermedad hepática o hipertensión.
6.Neoplasia maligna en los 5 años anteriores, EXCEPTO carcinoma basocelular o de células escamosas cutáneo tratado o que se considera curado, cáncer cervical in situ O carcinoma ductal de mama in situ.
7.Antecedentes de síntomas neurológicos que sugieren la existencia de enfermedad desmielinizante del sistema nervioso central o periférico.
8.Enfermedad inflamatoria crónica importante o enfermedad del tejido conectivo distinta de la AR, a excepción del síndrome de Sjögren secundario.
9.Patología médica concurrente que, en opinión del investigador, podría hacer que este estudio fuera perjudicial para el sujeto.
10.Valores analíticos anómalos en el momento de la selección, incluido cualquiera de los siguientes:
- hemoglobina <9 g/dl
- recuento de plaquetas <100 000/mm3
- recuento de leucocitos <3000/mm3
- aspartato aminotransferasa y/o alanina aminotransferasa ≥2,0 veces el límite superior de la normalidad
- aclaramiento de creatinina <50 ml/min (fórmula de Cockroft-Gault)
11. Uso de tratamientos biológicos comercializados o en investigación para la AR como se indica a continuación:
- anakinra o etanercept en el mes anterior a la primera dosis del producto en investigación
- abatacept, tocilizumab, adalimumab, golimumab o certolizumab en los 3 meses anteriores a la primera dosis del producto en investigación
- otros tratamientos biológicos experimentales o comercializados para la AR en los 3 meses o 5 semividas (el período que sea más largo) anteriores a la primera dosis del producto en investigación
- rituximab en los 9 meses anteriores al uso del producto en investigación junto con indicios de una recuperación incompleta de linfocitos B
12. Administración de vacunas vivas en los 28 días anteriores a la primera dosis del producto en investigación o previsión de recibir vacunas vivas en el transcurso del estudio.
13. Uso previo de Remicade® (infliximab) o de un biosimilar de infliximab.
14. Ser mujer embarazada o en período de lactancia o que tenga previsto quedarse embarazada mientras esté en el estudio o durante los 6 meses posteriores a la última dosis del producto en investigación.
15. Ser mujer con capacidad de concebir (esto es, no haberse sometido a una esterilización quirúrgica ni ser postmenopáusica) y no aceptar el uso de métodos anticonceptivos adecuados (p. ej., abstinencia total, esterilización, píldoras anticonceptivas, inyecciones de Depo-Provera® [medroxiprogesterona] o implantes anticonceptivos) durante su participación en el estudio y durante los 6 meses posteriores a la última dosis del producto en investigación.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is response difference of ACR20 at week 22

El criterio de valoración principal es la diferencia en la respuesta de ACR20 en la semana 22

E.5.1.1

Timepoint(s) of evaluation of this end point

To achieve ACR20 response, at least 20% improvement compared with baseline is required for both swollen joint count (SJC) and tender joint count (TJC) (66/68 joint counts), as well as for 3 out of the following 5 additional parameters:
•Subject's Global Health Assessment (on a 100-mm visual analogue scale [VAS])
•Investigator's Global Health Assessment (on a 100-mm VAS)
•subject's assessment of pain (on a 100-mm VAS)
•Health Assessment Questionnaire-Disability Index (HAQ-DI)
•serum CRP

Para alcanzar una respuesta de ACR20 se requiere un mejora de al menos el 20 % en comparación con el inicio en el recuento de articulaciones inflamadas (RAI) y el recuento de articulaciones dolorosas (RAD) (66/68 recuentos de articulaciones), así como en 3 de los 5 parámetros adicionales siguientes:
• Evaluación global de salud realizada por el paciente (en una escala visual analógica [EVA] de 100 mm)
•Evaluación global de salud realizada por el investigador (en una EVA de 100 mm)
• Evaluación de dolor realizada por el paciente (en una EVA de 100 mm)
• Cuestionario de evaluación de salud - Índice de discapacidad (HAQ-DI)
• PCR en suero

E.5.2

Secondary end point(s)

Secondary efficacy endpoints will be response difference of ACR20 and ACR50/ACR70, and DAS28-CRP.

Los criterios de valoración secundarios serán la diferencia en las respuestas ACR20 y ACR50/ACR70, y DAS28-CRP.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary Endpoint evaluations:
•response difference of ACR20 at weeks 2, 6, 14, 30, 34, 38, 46, and 50
•response difference of 50% improvement in ACR core set measurements (ACR50) and 70% improvement in ACR core set measurements (ACR70) at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50
•disease activity score in 28 joints - C-reactive protein (DAS28-CRP) change from baseline at weeks 2, 6, 14, 22, 30, 34, 38, 46, and 50
Safety endpoints:
•treatment-emergent adverse events, serious adverse events, and adverse events of special interest
•clinically significant changes in laboratory values and vital signs
•incidence of antidrug antibodies
Exploratory Endpoint:
•trough serum concentrations of ABP 710 and infliximab at weeks 2, 6, 14, and 22

Evaluaciones criterio valoración secundario:diferencia en la respuesta deACR20-semanas 2,6,14,30,38,46,50;diferencia en la respuesta de mejoría del 50 % en las medidas del grupo principal de respuesta ACR50 y en la de mejoría del 70 % en las medidas del grupo principal de respuesta ACR(70)- semanas2,6,14,30,38,46,50;cambio respecto al inicio en la puntuación de la actividad de la enfermedad en 28 articulaciones-proteína C reactiva-semanas2,6,14,22,30,34,38,46,50.Criterios valoración seguridad:acontecimientos adversos durante el tratamiento,SAEyAE de interés especial;cambios clínicamente significativos en los valores analíticos y constantes vitales;incidencia de anticuerpos antifármaco.Criterio valoración exploratorio:concentraciones séricas mínimas de ABP710 e infliximab-semanas 2,6,14,22

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

Yes

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Inmunogenicidad

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

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

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

Australia

Bulgaria

Canada

Czech Republic

Germany

Hungary

Poland

Romania

Spain

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

UVUS (ultima visita ultimo sujeto)

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

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:

495

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

454

F.4.2.2

In the whole clinical trial

550

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)

None

Ninguno

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2016-10-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-09-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-08-13

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Orphan Designation Number:
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