Clinical Trials Register

Summary
EudraCT Number:	2012-001176-10
Sponsor's Protocol Code Number:	CNTO136ARA3004
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:	2013-09-05
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

2012-001176-10

A.3

Full title of the trial

A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and CNTO136ARA3003 (SIRROUND-T)

Estudio multicéntrico, de grupos paralelos, de seguridad y eficacia a largo plazo de CNTO 136 (sirukumab) en artritis reumatoide en sujetos que han completado el tratamiento en los estudios CNTO136ARA3002 (SIRROUND-D) y CNTO136ARA3003 (SIRROUND-T)

A.3.1

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

Long-term Safety and Efficacy of Sirukumab in Participants with RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

Estudio de seguridad y eficacia a largo plazo de sirukumab en participantes con AR que hayan completado los estudio CNTO136ARA3002 o CNTO136ARA3003

A.3.2

Name or abbreviated title of the trial where available

SIRROUND-LTE

A.4.1

Sponsor's protocol code number

CNTO136ARA3004

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	Janssen-Cilag International N.V.
B.1.3.4	Country	Belgium
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	Janssen Research and Development, LLC
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	Janssen-Cilag International N.V
B.5.2	Functional name of contact point	Clinical Registry Group
B.5.3	Address:
B.5.3.1	Street Address	Janssen Biologics BV - Clinical Registry Group, Archimedesweg 29
B.5.3.2	Town/ city	Leiden
B.5.3.3	Post code	2333 CM
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	31(0)71524 21 66
B.5.5	Fax number	31(0)71524 21 10
B.5.6	E-mail	ClinicalTrialsEU@its.jnj.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	Sirukumab
D.3.2	Product code	CNTO136
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	Sirukumab
D.3.9.2	Current sponsor code	CNTO 136
D.3.9.3	Other descriptive name	Human anti-IL6 monoclonal antibody
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	50
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	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody
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	Sirukumab
D.3.2	Product code	CNTO136
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	Sirukumab
D.3.9.2	Current sponsor code	CNTO 136
D.3.9.3	Other descriptive name	Human anti-IL6 monoclonal antibody
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	50
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody
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	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	Sirukumab
D.3.2	Product code	CNTO136
D.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
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	Sirukumab
D.3.9.2	Current sponsor code	CNTO 136
D.3.9.3	Other descriptive name	Human anti-IL6 monoclonal antibody
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
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	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody
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	Sirukumab
D.3.2	Product code	CNTO136
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
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	Sirukumab
D.3.9.2	Current sponsor code	CNTO 136
D.3.9.3	Other descriptive name	Human anti-IL6 monoclonal antibody
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Monoclonal Antibody

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 in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection in pre-filled pen
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 reumatoide

E.1.1.1

Medical condition in easily understood language

Active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy or anti-TNF agents

Artritis reumatoide activa a pesar de un tratamiento con fármacos antirreumáticos modificadores de la enfermedad o a los agentes anti-TNF alfa.

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

The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying
antirheumatic drugs (DMARDs) or anti-TNF alpha agents

El propósito de este estudio es evaluar la seguridad a largo plazo del sirukumab en sujetos con artritis reumatoide que son resistentes a los fármacos antirreumáticos modificadores de la enfermedad (FARME) o a los agentes anti-TNF alfa.

E.2.2

Secondary objectives of the trial

The secondary objectives are to observe the following long-term effects of sirukumab in subjects with RA who are refractory to DMARDs or anti-TNF alpha agents on:
? Efficacy
? Pharmacokinetics
? Immunogenicity
? Pharmacodynamics
? Pharmacogenetics
? PFS-AI usability (as defined in a separate substudy protocol)

Los objetivos secundarios consisten en observar los siguientes efectos a largo plazo del sirukumab en sujetos con artritis reumatoide que son resistentes a los FARME o a los agentes anti-TNF alfa, sobre:
? Eficacia
? Farmacocinética
? Inmunogenia
? Farmacodinámica
? Farmacogenética
? Usabilidad de PFS-AI (según se define en el protocolo de un subestudio aparte)

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

Use of Autoinjector Substudy in CNTO136ARA3004: A Multicenter, Parallel-group Study of Long-term Safety and Efficacy of CNTO 136 (sirukumab) for Rheumatoid Arthritis in Subjects Completing Treatment in Studies CNTO136ARA3002 (SIRROUND-D) and
CNTO136ARA3003 (SIRROUND-T)

Please note that the sub-study protocol not yet finalized (expected July 2013).

Subestudio de usabilidad de autoinyector en CNTO136ARA3004: Estudio multicéntrico, de grupos paralelos, de seguridad y eficacia a largo plazo de CNTO 136 (sirukumab) en artritis reumatoide en sujetos que han completado el tratamiento en los estudios CNTO136ARA3002 (SIRROUND-D) y CNTO136ARA3003 (SIRROUND-T)

E.3

Principal inclusion criteria

Each potential subject must satisfy all of the following criteria to be enrolled in the study. Each subject must:
Inclusion Criteria:
- Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003
- Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Signed an informed consent form (ICF) for pharmacogenetics research (how a person?s genes may affect a drug?s effects) in order to participate in the optional pharmacogenetics component of this study.

Refusal to give consent for this component does not exclude a participant from participation in this clinical study.

Para poder entrar en el estudio, los posibles participantes deben cumplir todos los criterios que se indican a continuación. Cada sujeto debe:
- Haber completado su participación en los estudios CNTO136ARA3002 o CNTO136ARA3003.
- Firmar un documento de consentimiento informado que indique que comprende el objetivo y los procedimientos necesarios del estudio y que está dispuesto a participar en el estudio.
- Firmar el documento de consentimiento informado para la investigación farmacogenética con el fin de poder participar en el componente farmacogenético opcional de este estudio.

La denegación del consentimiento para este componente no excluirá al sujeto de la participación en el estudio clínico.

E.4

Principal exclusion criteria

Exclusion Criteria:
- Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003
- Is pregnant - Has active diverticulitis
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments

Criterios de exclusión:
- Retira su consentimiento y/o abandona su participación en los estudios CNTO136ARA3002 o CNTO136ARA3003.
- Está embarazada.
- Presenta diverticulitis activa.
- Padece cualquier afección que, en opinión del investigador, hace que su participación en el estudio no sea lo mas beneficioso para él (por ejemplo, pone en peligro su bienestar) o podría impedir o limitar las evaluaciones especificadas en el protocolo o ser un factor de confusión en ellas.

E.5 End points

E.5.1

Primary end point(s)

1) The number of participants with cardiovascular serious adverse events (SAEs)
2) The number of participants with malignancies
3) The number of participants with serious infections
4) The number of participants with gastrointestinal perforations

1) El número de sujetos con acontecimientos adversos cardiovasculares graves.
2) El número de sujetos con neoplasias malignas.
3) El número de sujetos con infecciones graves.
4) El número de sujetos con perforaciones gastrointestinales.

E.5.1.1

Timepoint(s) of evaluation of this end point

1-4) Up to 224 weeks

1-4) Más de 224 semanas

E.5.2

Secondary end point(s)

1) Observations of laboratory parameters of interest (neutrophils, platelets, hepatobiliary parameters, and lipid parameters).
2) Summary of toxicity grading
3) Proportion of participants who achieve ACR 20 response
4) Proportion of participants who achieve ACR 50 response
5) Proportion of participants who achieve ACR 70 response
6) Proportion of participants with DAS28 (CRP) response
7) Proportion of participants with DAS28 (CRP) remission
8) Change from baseline in DAS28 (CRP)
9) Proportion of participants with SDAI-based ACR/EULAR
remission
10) Proportion of participants with Boolean-based ACR/EULAR
remission
11) Change from baseline in SDAI
12) Change from baseline in CDAI
13) Change from baseline in HAQ-DI
14) Proportion of HAQ-DI responders (ie, those who have a change from baseline of > 0.22 in HAQDI score)
15) Change from baseline in Physical Component Score (PCS)
16) Change from baseline in Mental Component Score (MCS)
17) Change from baseline in domain scores of 36-item short form
health survey (SF-36)

1) Se observarán parámetros del laboratorio de interés (neutrófilos, plaquetas, parámetros hepatobiliares y lipidograma).
2) resumirá el grado de toxicidad.
3) Porcentaje de sujetos que alcanzan una respuesta ACR 20
4) Porcentaje de sujetos que alcanzan una respuesta ACR 50
5) Porcentaje de sujetos que alcanzan una respuesta ACR 70
6) Porcentaje de sujetos con respuesta DAS28 (CRP)
7) Porcentaje de sujetos en remisión DAS28 (CRP)
8) Cambio respecto al momento basal en DAS28 (CRP)
9) Porcentaje de sujetos en remisión ACR/EULAR según SDAI
10) Porcentaje de sujetos en remisión ACR/EULAR según criterios booleanos
11) Cambio respecto al momento basal en SDAI
12) Cambio respecto al momento basal en CDAI
13) Cambio respecto al momento basal en HAQ-DI
14) Porcentaje de respondedores HAQ-DI (es decir, con cambio respecto al momento basal > 0,22 en la puntuación del HAQ-DI)
15) Cambios frente al momento basal en las puntuaciones de los componentes físico (PCS)
16) Cambios frente al momento basal en las puntuaciones de los componentes mental (MCS)
17) Cambios frente al momento basal en las puntuaciones de los dominios de la encuesta de salud, formato breve de 36 ítems (SF 36).

E.5.2.1

Timepoint(s) of evaluation of this end point

1-2) Up to 224 weeks
3-17) Up to 208 weeks

1-2) Más de 224 semanas.
3-17) Más de 208 semanas.

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

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

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

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

100

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

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

Chile

China

Colombia

France

Germany

Italy

Japan

Korea, Republic of

Lithuania

Malaysia

Mexico

Netherlands

New Zealand

Peru

Poland

Portugal

Romania

Russian Federation

Serbia

South Africa

Spain

Taiwan

Ukraine

United Kingdom

United States

Croatia

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

Subjects must remain in the study until the last scheduled visit followed by 16 weeks of safety and efficacy follow up to be considered as having completed participation in the study.

Para que se considere que sujeto ha completado su participación en el estudio, deberá permanecer en el estudio hasta la última visita programada y someterse después a 16 semanas de seguimiento de la seguridad y la eficacia.

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

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:

1890

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

275

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

378

F.4.2.2

In the whole clinical trial

2165

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)

It is planned that sirukumab will be commercially available to patients and that patients who have responded to treatment would have sirukumab available. In case that sirukumab will not be marketed within the 5 year treatment period and additional data would be required for health authority approval, it would not be appropriate to continue treatment with sirukumab until that situation could be resolved. At that point patients will return to available standard care as per investigator discretion.

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

2013-10-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-14

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-05-01

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