Clinical Trials Register

Summary
EudraCT Number:	2012-002760-27
Sponsor's Protocol Code Number:	CAIN457F2309E1
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-10-30
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-002760-27

A.3

Full title of the trial

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis

Studio di estensione della durata di 4 anni per valutare il profilo di efficacia, sicurezza e tollerabilita' di secukinumab in pazienti affetti da artrite reumatoide attiva.

A.3.1

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

A four year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis.

Studio di estensione di 4 anni per valutare l'efficacia, la sicurezza e la tollerabilità a lungo termine di secukinumab in pazienti con artrite reumatoide attiva.

A.4.1

Sponsor's protocol code number

CAIN457F2309E1

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	NOVARTIS FARMA
B.1.3.4	Country	Italy
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	NOVARTIS
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novartis Farma
B.5.2	Functional name of contact point	Drug Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni, 1
B.5.3.2	Town/ city	Origgio
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	+39 02 96541
B.5.5	Fax number	+39 02 9659066
B.5.6	E-mail	info.studiclinici@novartis.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	secukinumab
D.3.2	Product code	AIN457
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SECUKINUMAB
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.4	EV Substance Code	SUB33242
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	150
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	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	secukinumab
D.3.2	Product code	AIN457
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SECUKINUMAB
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.4	EV Substance Code	SUB33242
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	75
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
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
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

Artrite reumatoide

E.1.1.1

Medical condition in easily understood language

Rheumatoid arthritis

Artrite 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	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.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	LLT
E.1.2	Classification code	10037738
E.1.2	Term	R arthritis
E.1.2	System Organ Class	10028395 - Musculoskeletal and connective tissue disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the long-term efficacy of secukinumab with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients who completed the phase III study CAIN457F2309

Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab (somministrato in formulazione liquida tramite siringa pre-riempita) nel raggiungimento dei parametri ACR20, ACR50 e ACR70 fino al mese 60 in pazienti con artrite reumatoide attiva con risposta inadeguata od intolleranti ad agenti anti-TNFα, e che avevano completato lo studio di fase 3 CAIN457F2309.

E.2.2

Secondary objectives of the trial

1) To evaluate the long-term efficacy of secukinumab with respect to changes in HAQ-DI relative to baseline over time up to Month 60 2) To evaluate the long-term efficacy of secukinumab with respect to the proportion of subjects achieving major clinical response (continuous sixmonth period of ACR70 response) over time up to Month 60 3) To evaluate the long-term efficacy of secukinumab with respect to the changes in DAS28 relative to baseline over time up to Month 60

1. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab in merito alle variazioni del HAQ-DI rispetto al basale fino al mese 60. 2. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab rispetto alla proporzione di pazienti che hanno raggiunto la risposta clinica maggiore (risposta ACR70 mantenuta per 6 mesi) fino al mese 60. 3. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab in merito alle variazioni del DAS28 rispetto al basale fino al mese 60 4. Valutare l’efficacia a lungo termine di due differenti dosaggi di secukinumab rispetto alla proporzione di pazienti che hanno raggiunto una bassa attività di malattia (DAS28≤3.2) e una risposta EULAR buona/moderata fino al mese 60 5. PER FAVORE VEDERE SINOSSI

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Subjects who provide a written, signed and dated informed consent before any study assessment is performed 2) Subjects must have participated in phase III study CAIN457F2309, must have completed the entire treatment period and must have received secukinumab during phase III study (either from start of phase III study or after re-assignment to one of the secukinumab arms after week 16/24) 3) Subjects who are deemed by the investigator to benefit from continued secukinumab therapy

1. I soggetti devono essere capaci di capire e comunicare con lo sperimentatore, devono ottemperare alle richieste dello studio e devono fornire un consenso informato scritto, firmato e datato prima che qualsiasi valutazione sia effettuata 2. I soggetti devono aver partecipato allo studio di fase 3 CAIN457F2309, devono aver completato l’intero periodo di trattamento e devono aver ricevuto secukinumab (a partire dall’inizio, o dopo la riallocazione ad uno dei bracci con di trattamento dopo la settimana 16/24) 3. I soggetti che secondo il giudizio dell’investigatore possano trarre beneficio dalla prosecuzione della terapia con secukinumab

E.4

Principal exclusion criteria

1) Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab 2) Any subject who is deemed not to be benefiting from the study drug based upon lack of improvement or worsening of their symptoms 3) Any subject who continued to receive abatacept after week 16 during the phase III study CAIN457F2309 Other protocol-defined exclusion criteria may apply

I soggetti che soddisfano qualsiasi dei seguenti criteri non sono eleggibili per l’inclusione in questo studio. 1. Qualsiasi soggetto che assume in concomitanza agente/i biologico/i immunomodulante/i ad eccezione di secukinumab 2. Qualsiasi soggetto che non possa trarre beneficio dal farmaco in studio basandosi sulla mancanza di miglioramento o sul peggioramento dei sintomi 3. Qualsiasi soggetto che ha continuato a ricevere abatacept dopo la settimana 16 durante lo studio di fase 3 CAIN457F2309 4. Donne gravide oppure che stanno allattando, dove la gravidanza è definita come lo stato di una donna dal concepimento fino al termine della gestazione, confermata da un test di laboratorio positivo per hCG (>10 mIU/mL) 5. Donne in età fertile, definite come tutte le donne psicologicamente in grado di intraprendere una gravidanza, che non desiderino utilizzare metodi di contraccezione efficaci durante lo studio e per 16 settimane dopo il termine del trattamento.

E.5 End points

E.5.1

Primary end point(s)

ACR 20, 50 and 70

ACR 20, 50 e 70

E.5.1.1

Timepoint(s) of evaluation of this end point

Over the entire duration of the study up to Month 60

Copre l'intera durata dello studio fino al mese 60

E.5.2

Secondary end point(s)

1) Questionnaire Disability Index (HAQ-DI) 2) Major clinical response 3) DAS28

E.5.2.1

Timepoint(s) of evaluation of this end point

Over the entire duration of the study up to Month 60

Copre l'intera durata dello studio fino al mese 60

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

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

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

Immunizzazione

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

Yes

E.8.1.7.1

Other trial design description

double-dummy (doppio fantasma)

double-dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

no placebo e no farmaco di confronto - Stesso farmaco ad altro dosaggio

no placebo or active control group - same IMP used at different dosage

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

Brazil

Canada

Colombia

Mexico

Russian Federation

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

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:

276

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

164

F.4.2.2

In the whole clinical trial

345

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)

The investigator must provide follow-up medical care for all subjects who leave the study, or must refer them for appropriate ongoing care. This care may include initiating another treatment outside of the study as deemed appropriate by the investigator. This treatment may be any non-biologic DMARD. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended

Il ricercatore deve fornire l'assistenza medica necessaria a tutti i pazienti che lasciano lo studio, o devono farli riferimento per la terapia più appropriata. Questa terapia può comprendere l'inizio di un altro trattamento al di fuori dello studio come ritenuto più appropriato dal ricercatore. Questo trattamento potrebbe essere DMARD non biologico ma in caso di trattamento biologico é raccomandato un periodo di attesa di 3 mesi prima dell'inizio del nuovo trattamento.

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

2012-11-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-10-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-04-07

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