Clinical Trials Register

Summary
EudraCT Number:	2013-001241-13
Sponsor's Protocol Code Number:	CAIN457F2306E1
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-08-14
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

Czechia - SUKL

A.2

EudraCT number

2013-001241-13

A.3

Full title of the trial

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

Tříleté navazující klinické hodnocení dlouhodobé účinnosti, bezpečnosti a snášenlivosti secukinumabu u pacientů s aktivní psoriatickou artritidou.

A.3.1

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

Extension study up to three years for secukinumab in psoriatic arthritis

Tříleté navazující klinické hodnocení se secukinumabem u psoriatické artritidy

A.4.1

Sponsor's protocol code number

CAIN457F2306E1

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 Pharma Services AG
B.1.3.4	Country	Switzerland
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 Pharma Services AG
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 s.r.o.
B.5.2	Functional name of contact point	Informační služba - klin. hodnocení
B.5.3	Address:
B.5.3.1	Street Address	Na Pankráci 1724/129
B.5.3.2	Town/ city	Praha 4
B.5.3.3	Post code	140 00
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	+420225 775 207
B.5.5	Fax number	+420225 775 205
B.5.6	E-mail	dotazy.klinickehodnoceni@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	Yes
D.2.1.1.1	Trade name	COSENTYX
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm 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	Secukinumab
D.3.2	Product code	AIN457
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	Secukinumab
D.3.9.1	CAS number	1229022-83-6
D.3.9.2	Current sponsor code	AIN457
D.3.9.3	Other descriptive name	SECUKINUMAB
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 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	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 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 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

Psoriatic arthritis

Psoriatická artritida

E.1.1.1

Medical condition in easily understood language

Psoriatic arthritis

Zánět kloubů při onemocnění lupénkou

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	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

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 (provided as pre-filled syringes) with respect to ACR20, ACR50 and ACR70 response over time up to Week 260 in subjects with active psoriatic arthritis and who complete the phase III study CAIN457F2306

Zhodnotit dlouhodobou účinnost secukinumabu (podávaných ve formě předplněných injekčních stříkaček) s ohledem na ACR20, ACR50 a ACR70-odpověď v průběhu času až do týdne 260 u pacientů s aktivní psoriatickou artritidou, kteří ukončili fázi III studie CAIN457F2306.

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 Week 260
- The proportion of subjects with improvements from baseline in HAQ-DI meeting or exceeding minimal clinically important difference (MCID) over time up to Week 260
- The changes in DAS28 (utilizing hsCRP) relative to baseline over time up to Week 260
- The proportion of subjects achieving low disease activity (DAS28 ≤3.2) and disease remission as defined by DAS28 (DAS28 <2.6) over time up to Week 260

2. To evaluate the long term safety and tolerability of secukinumab as assessed by vital signs, clinical laboratory variables, and adverse events monitoring over time up to Week 260

1. Zhodnotit dlouhodobou účinnost secukinumabu s ohledem na:
- Změny v HAQ-DI v průběhu času až do týdne 260, vztažené k počátečnímu stavu
-Podíl subjektů se zlepšením stavu v porovnání s HAQ-DI na počátku měření, nebo převyšující minimální klinicky významný rozdíl (MCID) v průběhu času až do týdne 260
-Změny v DAS28 (využívající hsCRP) vztažené k počátečnímu stavu v průběhu času až do týdne 260
-Podíl subjektů, kteří dosáhli nízké aktivity onemocnění (DAS28 ≤3,2) a remise onemocnění, jak je definováno v DAS28 (DAS28 <2,6) v průběhu času až do týdne 260

2.Zhodnotit dlouhodobou bezpečnost a snášenlivost secukinumabu podle hodnocení vitálních známek, klinických laboratorních proměnných a nežádoucích příhod sledovaných v průběhu času až do týdne 260

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
- Subjects must be deemed by the investigator to benefit from continued secukinumab therapy

Other protocol-defined inclusion criteria may apply.

-Subjekty KH musí být schopné porozumět zkoušejícímu a komunikovat s ním, a dodržet požadavky klinického hodnocení, a musí poskytnout podepsaný a odatovaný písemný informovaný souhlas před zahájením jakéhokoli vyšetření v KH.
-Subjekty se musí účastnit v základním klinickém hodnocení CAIN457F2306, a musí mít ukončenou celou fázi léčby
-Subjekty musí být považovány zkoušejícím za subjekty, které mají prospěch z pokračující léčby secukinumabem

Ostatní protokolem definovaná vstupní kritéria se mohou uplatnit.

E.4

Principal exclusion criteria

- Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
- Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unless they are using effective methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., 20 weeks in EU).

Other protocol-definied exclusion criteria may apply.

-Jakýkoli subjekt užívající současně jiný/é biologický/é imunomodulující přípravek/přípravky, kromě secukinumabu
-Jakýkoli subjekt, u kterého se lze domnívat, že nebenefituje z léčby ve studii na základě chybějícího zlepšení nebo na základě zhoršení příznaků jeho onemocnění
-Těhotné nebo kojící ženy
-Ženy v reprodukčním věku kromě těch, které používají účinné metody kontracepce během celého trvání studie nebo déle, pokud je to vyžadováno lokálně schválenou informací o předepsaném léku (např. 20 týdnů v EU).

Ostatní protokolem definovaná vyřazovací kritéria se mohou uplatnit.

E.5 End points

E.5.1

Primary end point(s)

ACR20, ACR50 and ACR70

ACR20, ACR50 a ACR70

E.5.1.1

Timepoint(s) of evaluation of this end point

Over the entire duration of the study up to Week 260

Po celou dobu trvání klinického hodnocení až do týdne 260

E.5.2

Secondary end point(s)

- Change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
- Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Disability Index (HAQ-DI)
- Change from baseline in DAS28
- Subjects achieving low disease activity and disease remission
- Safety and tolerability

-Změna v Health Assessment Questionnaire Disability Index (HAQ-DI) od počátečního stavu
-Minimální klinicky významný rozdíl (MCID) v Health Assessment Questionnaire Disability Index (HAQ-DI)
-Změna v DAS28 od počátečního stavu
-Subjekty dosahující nízké aktivity onemocnění a remise onemocnění
-Bezpečnost a snášenlivost

E.5.2.1

Timepoint(s) of evaluation of this end point

Over the entire duration of the study up to Week 260

Po celou dobu trvání klinického hodnocení až do týdne 260

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

Imunogennost

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Není zde žádná placebová kontrolní skupina, placebo se používá pouze k zaslepení mezi 2 režimy

There is no placebo control group, the placebo is only used to keep the blind between the 2 regimens

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

Australia

Belgium

Brazil

Bulgaria

Canada

Czech Republic

Germany

Israel

Italy

Philippines

Poland

Romania

Russian Federation

Singapore

Slovakia

Thailand

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

LVLS

Poslední návštěva posledního subjektu ve studii

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.1.1.1

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:

402

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

155

F.4.2.2

In the whole clinical trial

460

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 are prematurely withdrawn from the study, or must refer them for appropriate ongoing care. This care may include another treatment outside of the study as deemed appropriate by the investigator. This treatment may be non-biologic DMARD. In case of a biologic treatment, a waiting period of 3 months before initiating the treatment is recommended.

Zkoušející musí zajistit následnou lékařskou péči pro všechny subjekty, které předčasně ukončí klinické hodnocení, nebo je musí odkázat na vhodnou pokračující péči. Tato péče může zahrnovat jinou léčbu mimo toto klinické hodnocení, která je zvážena zkoušejícím jako léčba vhodná. Touto léčbou mohou být nebiologická DMARD. V případě, že je zvažována nějaká biologická léčba, doporučuje se počkat 3 měsíce, než je tato léčba zahájena.

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

2013-09-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-09-11

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-01-11

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IMP with orphan designation in the indication
Orphan Designation Number:
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