Clinical Trials Register

Summary
EudraCT Number:	2013-001417-32
Sponsor's Protocol Code Number:	CNTO136ARA3005
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:	2014-05-22
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

2013-001417-32

A.3

Full title of the trial

A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis

Estudio multicéntrico, aleatorizado, en doble ciego y de grupos paralelos, de la administración subcutánea de CNTO 136 (sirukumab) en monoterapia, comparado con adalimumab en monoterapia, en sujetos con artritis reumatoide activa

A.3.1

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

A Study Comparing Sirukumab (CNTO 136) Monotherapy with Adalimumab (HUMIRA®) Monotherapy in the Treatment of Active Rheumatoid Arthritis

Un estudio que compara Sirukumab (CNTO 136) en monoterapia con Adalimumab (HUMIRA®) en monoterapia en el tratamiento de la artritis reumatoide activa.

A.3.2

Name or abbreviated title of the trial where available

SIRROUND-H

A.4.1

Sponsor's protocol code number

CNTO136ARA3005

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02019472

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	+34 91 391 34 43
B.5.5	Fax number	+3171524 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.3.9.3	Other descriptive name	CNTO 136
D.3.9.4	EV Substance Code	SUB26726
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: 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 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.3.9.3	Other descriptive name	CNTO 136
D.3.9.4	EV Substance Code	SUB26726
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: 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	Humira
D.2.1.1.2	Name of the Marketing Authorisation holder	AbbVie Ltd
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Adalimumab
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	ADALIMUMAB
D.3.9.1	CAS number	331731-18-1
D.3.9.4	EV Substance Code	SUB20016
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	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 in pre-filled syringe
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 with intolerance towards Methotrexate (MTX) or inappropriate conditioning for MTX treatment or inadequate response to MTX therapy.

Artritis reumatoide activa con intolerancia al metotrexato (MTX) o condiciones inapropiadas para el tratamiento con MTX o respuesta inadecuada al terapia con MTX.

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	17.0
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 is to demonstrate the superior efficacy of sirukumab monotherapy compared with adalimumab monotherapy in biologic naïve subjects with active RA who are intolerant to MTX, who are considered inappropriate for continued treatment with MTX or who are inadequate responders to MTX.

El objetivo principal es demostrar que la eficacia de la monoterapia con sirukumab es superior a la de la monoterapia con adalimumab en sujetos con artritis reumatoide activa no tratados previamente con agentes biológicos y que presentan intolerancia al metotrexato (MTX), se consideran inadecuados para continuar el tratamiento con MTX o han presentado una respuesta inadecuada al MTX.

E.2.2

Secondary objectives of the trial

The secondary objectives are to assess the following for sirukumab:
- Safety
- Physical function
- Pharmacokinetics, pharmacodynamics, and immunogenicity

Los objetivos secundarios son evaluar lo siguiente con sirukumab:
- Seguridad
- Función física
- Farmacocinética, farmacodinámica e inmunogenia

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

Mechanistic Substudy, 3 December 2013:
This optional mechanistic substudy will be conducted in a limited number of consenting subjects to explore the effect of sirukumab versus adalimumab at the disease site, ie, the inflamed joint, and to explore novel epigenetic imaging tissue and blood markers. The substudy will provide unique data to advance the understanding of the molecular and cellular mechanisms of action of sirukumab and its potential differentiation from anti-TNF alfa agents.

Objectives of the substudy:
- Assess the effect of sirukumab and adalimumab on synovial and systemic inflammatory markers and epigenetic markers
- Assess the effects of sirukumab and adalimumab on synovial vascularity as measured by Power Doppler Sonography (PDS) over time.

Subestudio del mecanismo de acción, 3 de diciembre de 2013.
Este subestudio opcional del mecanismo de acción se llevará a cabo en un número limitado de sujetos que otorguen su consentimiento para para explorar el efecto del sirukumab, en comparación con el adalimumab, sobre el área de la enfermedad, es decir, la articulación inflamada, y para explorar novedosos marcadores de imagen epigenéticos tisulares y sanguíneos. Este subestudio podría aportar unos datos únicos para avanzar en el conocimiento de los mecanismos de acción moleculares y celulares del sirukumab y posibilitar su diferenciación frente a los agentes anti-TNF alfa.
Objetivos del subestudio:
- Evaluar el efecto del sirukumab y del adalimumab sobre marcadores inflamatorios sinoviales y sistémicos y sobre marcadores epigenéticos
- Evaluar los efectos del sirukumab y del adalimumab sobre la vascularización sinovial a lo largo del tiempo, en su medición mediante ecografía Doppler no direccional.

E.3

Principal inclusion criteria

1. Have a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening

2. Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline

4. Have previous or current treatment with methotrexate (MTX) and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, and/or an inadequate responder to methotrexate

5. Must not have received MTX or any other non-biologic DMARD including but not limited to sulfasalazine, hydroxychloroquine, chloroquine, and bucillamine for at least 2 weeks prior to the first administration of the study agent

6. C-reactive protein >= 10.00 mg/L or erythrocyte sedimentation rate >=28 mm/hr at screening

1. Haber sido diagnosticado de artritis reumatoide como mínimo 6 meses antes de la selección.
2. Presentar una artritis reumatoide de grado moderado a severo de actividad con como mínimo 8 de 68 articulaciones con dolor a la palpación y 6 de 66 articulaciones con tumefacción, en la selección y en el basal.
3. Haber recibido tratamiento previo o estar en tratamiento actualmente con MTX y/o que se considere que presenta intolerancia al MTX, y/o que se considere que es inadecuado para el tratamiento con MTX, y/o haber presentado una respuesta inadecuada al MTX
4. No deberá haber recibido MTX u otro FARME no biológico, tales como, entre otros, sulfasalazina, hidroxicloroquina, cloroquina y bucilamina, durante como mínimo las 2 semanas previas a la primera administración del agente del estudio.
5. Proteína C reactiva >/= 10,00 mg/L o velocidad de sedimentación globular >/= 28mm/h en la selección.

E.4

Principal exclusion criteria

1. Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis

2. Has ever received biologic therapy for RA, including but not limited to the following: TNF-alpha inhibitors, tocilizumab, rituximab, anakinra, abatacept

3. Has ever used tofacitinib therapy or any other JAK inhibitor

4. Has received intra-articular, intramuscular, or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration

5. Has received leflunomide within 24 months before the first study agent administration and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable

1. Presenta clase IV según la Clasificación por el ACR del estado funcional de la artritis reumatoide.
2. Ha recibido en algún momento un tratamiento biológico para la artritis reumatoide, incluyendo pero no limitado a: inhibidor TNF-Alfa, tocilizumab, rituximab, anakinra, abatacept.
3. Ha recibido en algún momento tratamiento con tofacitinib o cualquier otro inhibidor de JAK
4. Ha recibido corticosteroides intraarticulares, intramusculares o intravenosos para la artritis reumatoide, incluida corticotropina, durante las 4 semanas previas a la primera administración del fármaco en estudio
5. Ha recibido leflunomida en los 24 meses previos a la primera administración del agente del estudio y no ha sido sometido a ningún procedimiento de eliminación del fármaco, salvo que se mida el metabolito M1 y sea indetectable.

E.5 End points

E.5.1

Primary end point(s)

1. Change from baseline in Disease Activity Index Score 28 using erythrocyte sedimentation rate [DAS28 (ESR)]

2. Percentage of subjects with an American College of Rheumatology 50 (ACR 50) response

1. Cambio frente al basal en DAS28 (ESR) en la Semana 24.
2. Porcentaje de sujetos con respuesta ACR 50 en la Semana 24

E.5.1.1

Timepoint(s) of evaluation of this end point

1, 2) at week 24

1 , 2 en la semana 24.

E.5.2

Secondary end point(s)

Major Secondary Endpoints
1. Percentage of subjects with DAS28 (ESR) remission

2. Percentage of subjects with an ACR 20 response

Other secondary endpoints:
3. Proportion of subjects with DAS (ESR) response at Weeks 24 and 52

4. Proportion of subjects with DAS28 (CRP) response at Weeks 24 and 52

5. Proportion of subjects with DAS (ESR) remission at Week 52

6. Proportion of subjects with DAS28 (CRP) remission at Weeks 24 and 52

7. Change from baseline in DAS28 (ESR) and DAS28 (CRP) over time by time point

8. Proportion of patients with EULAR low disease (DAS28 < 3.2) activity at Weeks 24 and 52

9. Proportion of subjects who achieve ACR 20 response at Weeks 52

10. Proportion of subjects who achieve ACR 50 response at Week 52

11. Proportion of subjects who achieve ACR 70 responses at Weeks 24 and 52

12. Proportion of subjects who achieve ACR 20, ACR 50, and ACR 70 response over time by time point

13. Percent improvement from baseline in ACR components at Weeks 24 and 52

14. Proportion of subjects who achieve major clinical response by Week 52

15. Proportion of subjects with SDAI-based ACR/EULAR remission at Weeks 24 and 52

16. Proportion of subjects with Boolean-based ACR/EULAR remission at Weeks 24 and 52

17. CDAI remission/low disease activity at Weeks 24 and 52

18. Change from baseline in SDAI at Weeks 24 and 52

19. Change from baseline in CDAI at Weeks 24 and 52

20. Change from baseline in HAQ-DI score at Weeks 24 and 52

21. AUC of change from baseline in HAQ-DI score from Week 0 through Week 24

22. Proportion of HAQ-DI responders (ie, those who have a change from baseline of > 0.22 in HAQ-DI score) at Weeks 24 and 52

23. Change from baseline in duration of morning stiffness at Weeks 24 and 52

24. Change from baseline in physical and mental component scores and in domain scores of SF-36 at Weeks 24 and 52

25. Change from baseline in FACIT-Fatigue at Weeks 24 and 52

26. Change from baseline in EQ-5D VAS and in EQ-5D index at Week 52

Criterios de valoración secundarios mayores
1. Porcentaje de sujetos con remisión según DAS28 (ESR) en la Semana 24.
2. Porcentaje de sujetos con respuesta ACR 20 en la Semana 24.
Otros criterios secundarios de valoración:
3. Porcentaje de sujetos con respuesta DAS (ESR) en las Semanas 24 y 52
4. Porcentaje de sujetos con respuesta DAS28 (CRP) en las Semanas 24 y 52
5. Porcentaje de sujetos con remisión DAS (ESR) en la Semana 52
6 Porcentaje de sujetos con remisión DAS28 (CRP) en las Semanas 24 y 52
7. Cambio frente al basal en DAS28 (ESR) y en DAS28 (CRP) a lo largo del tiempo por punto de tiempo
8. Porcentaje de pacientes con baja actividad de la enfermedad según EULAR (DAS28 <3,2) en las Semanas 24 y 52
9. Porcentaje de sujetos que alcanzan una respuesta ACR 20 en la Semana 52
10. Porcentaje de sujetos que alcanzan una respuesta ACR 50 en la Semana 52
11. Porcentaje de sujetos que alcanzan respuestas ACR 70 en las Semanas 24 y 52
12. Porcentaje de sujetos que alcanzan una respuesta ACR 20, ACR 50 y ACR 70 a lo largo del tiempo por punto de tiempo.
13. Mejoría porcentual frente al basal en los componentes del ACR en las Semanas 24 y 52.
14. Porcentaje de sujetos que alcanzan una respuesta clínica mayor en la Semana 52
15. Porcentaje de sujetos con remisión según ACR/EULAR basada en SDAI en las Semanas 24 y 52
16. Porcentaje de sujetos con remisión según ACR/EULAR basada en criterios booleanos en las Semanas 24 y 52
17. Remisión/baja actividad de la enfermedad según CDAI en las Semanas 24 y 52
18. Cambio frente al basal en SDAI en las Semanas 24 y 52
19. Cambio frente al basal en CDAI en las Semanas 24 y 52
20. Cambio frente al basal en la puntuación de HAQ-DI en las Semanas 24 y 52
21. AUC del cambio frente al basal en la puntuación de HAQ-DI desde la Semana 0 hasta la Semana 24
22. Porcentaje de respondedores según HAQ-DI (esto es, sujetos con un cambio frente al basal >0,22 en la puntuación HAQ-DI) en las Semanas 24 y 52
23. Cambio frente al basal en la duración de la rigidez matutina en las Semanas 24 y 52
24. Cambio frente al basal en las puntuaciones de los componentes físico y mental y en las puntuaciones de los dominios de SF 36 en las Semanas 24 y 52
25. Cambio frente al basal en FACIT-Fatigue en las Semanas 24 y 52
26. Cambio frente al basal en la escala analógica visual y en el índice de EQ-5D en la Semana 52

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 2) at week 24

3, 4, 6, 8, 11, 13, 15-20, 22-25) at weeks 24 and 52

5, 9, 10, 14, 26) at week 52

7, 12) over time by time point

21) from week 0 through week 24

1, 2) en la semana 24
3, 4, 6, 8, 11, 13, 15-20, 22-25) en la semana 24 y 52
5, 9, 10, 14, 26) en la semana 52
7, 12) a lo largo del tiempo por punto de tiempo
21)
22) desde la Semana 0 hasta la Semana 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

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

Yes

E.6.13.1

Other scope of the trial description

- Immunogenicity
- Physical function

-Inmunogenia
-Función física

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

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

Austria

Brazil

Bulgaria

Chile

Colombia

Germany

Hungary

Lithuania

Mexico

Moldova, Republic of

Peru

Poland

Romania

Russian Federation

Serbia

Slovakia

South Africa

Spain

Sweden

Ukraine

United Kingdom

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

The study is considered completed with the last visit (the last visit of the safety follow-up phase) for the last subject participating in the study.

El estudio es considerado como completado con la última visita (última visita de la fase de seguimiento de la seguridad) del último paciente participante en el estudio.

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:

423

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

126

F.4.2.2

In the whole clinical trial

510

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 by study end, patients will return to available standard care as per investigator discretion.

Está previsto que sirukumab este comercialmente disponible para los pacientes y que los pacientes que hayan respondido al tratameinto tendrían disponible sirukumab. En el caso que sirukumab no este comercializado al término del estudio, los pacientes regresaran al tratamiento estándar disponible según el criterio del investigador.

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

2014-06-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-10

P. End of Trial
P.	End of Trial Status	Completed

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Orphan Designation Number:
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