Clinical Trials Register

Summary
EudraCT Number:	2016-003761-26
Sponsor's Protocol Code Number:	CAIN457F2304
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:	2020-11-10
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

2016-003761-26

A.3

Full title of the trial

A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis

Studio in tre parti randomizzato, in doppio cieco,
controllato verso placebo, per indagare l¿efficacia e la
sicurezza della terapia con secukinumab per due tipi di
artrite idiopatica giovanile: artrite psoriasica e artrite
entesite-relata
Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis

A.3.1

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

Secukinumab safety and efficacy in JPsA and ERA

Sicurezza e efficacia di secukinumab in pazienti con l'artrite idiopatica giovanile

A.3.2

Name or abbreviated title of the trial where available

Secukinumab safety and efficacy in JPsA and ERA

Sicurezza e efficacia di secukinumab in pazienti con l'artrite idiopatica giovanile

A.4.1

Sponsor's protocol code number

CAIN457F2304

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN12345678

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT12345678

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1234-1234-1234

A.5.4

Other Identifiers

Name:

AIN457F

Number:

CAIN457F2304

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/168/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	NOVARTIS PHARMA 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 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 Farma
B.5.2	Functional name of contact point	Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	Largo Umberto Boccioni, 1
B.5.3.2	Town/ city	Origgio VA
B.5.3.3	Post code	21040
B.5.3.4	Country	Italy
B.5.4	Telephone number	00390296541
B.5.5	Fax number	0039029659066
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	Yes
D.2.1.1.1	Trade name	COSENTYX - 150 MG - SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA -USO SOTTOCUTANEO - SIRINGA (VETRO) 1 ML (150MG/ML)- 1 SIRINGA PRERIEMPITA
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVARTIS EUROPHARM LTD
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	NA
D.3.2	Product code	AIN457F
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.3.9.3	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.3.9.3	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	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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

Artrite idiopatica giovanile: artrite psoriasica e artrite
entesite-relata

E.1.1.1

Medical condition in easily understood language

Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis

Artrite giovanile

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	20.0
E.1.2	Level	PT
E.1.2	Classification code	10076674
E.1.2	Term	Juvenile psoriatic 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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10072745
E.1.2	Term	Enthesitis related 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 demonstrate that the time to flare in Treatment Period 2 is longer with secukinumab for combined ERA and JPsA groups than with placebo.

Dimostrare che il tempo di sviluppo di una riacutizzazione nel periodo di Trattamento 2 ¿ maggiore con il secukinumab per i gruppi combinati JPsA e ERA rispetto al placebo

E.2.2

Secondary objectives of the trial

1. To evaluate the effect of secukinumab treatment for all patients and each JIA category in Treatment Period 1 up to Week 12 (end of Treatment period 1) with respect to:
¿ JIA ACR (American College of Rheumatology) 30/50/70/90/100 and inactive disease status
¿ Each JIA ACR core component
¿ Change from baseline Juvenile Arthritis Disease Activity Score (JADAS)
¿ Total enthesitis count
¿ Total dactylitis count
2. To evaluate withdrawal effect of secukinumab treatment for all patients and each JIA category during and at the end of Treatment Period 2 with respect to:
¿ JIA ACR 30/50/70/90/100 and inactive disease status
3. To evaluate Pharmacokinetics (PK) of secukinumab and confirm the predicted dose in Treatment Period 1
4. To evaluate the safety/tolerability and immunogenicity of Secukinumab

1. Valutare l¿effetto della terapia con secukinumab per tutti i pazienti e per ogni categoria AIG nel Periodo di trattamento 1 fino alla settimana 12 (fine del periodo di trattamento 1) rispetto a:
¿ JIA ACR (American College of Reumathology) 30/50/70/90/100 e status di malattia inattiva
¿ Ogni componente del core JIA ACR
¿ Modifica rispetto alla baseline dello score JADAS (Jouvenile Arthritis Disease Activity Score)
¿ Conta delle entesiti totali
¿ Conta delle dattiliti totali
2. Valutare l¿effetto della sospensione randomizzata della terapia con il secukinumab per entrambe le categorie AIG e per ogni singola categoria durante e alla fine del periodo di Trattamento 2 rispetto a :
¿ JIA ACR 30/50/70/90/100 e status di malattia inattiva
3. Valutare il profilo di farmacocinetica del secukinumab (PK) e confermare le predette dosi nel Periodo di Trattamento 1
4. Valutare il profilo di sucurezza/tollerabilit¿ e immunogenicit¿ del secukinumab

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the international League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration.
2. Active disease (ERA or JPsA) defined as having both:
- at least 3 active joints
- at least 1 site of active enthesitis at baseline or documented by history.
3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs (NSAID)
4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD)
5. No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.

Other protocol-defined inclusion/exclusion criteria apply.

1. Pazienti di sesso maschile o femminile =2 anni di età e <18 anni di età al momento dello screening.
2. Diagnosi di ERA confermata secondo i criteri di classificazione ILAR o di JPsA secondo i criteri di classificazione ILAR modificati che deve essere stata fatta al minimo 6 mesi prima della visita di screening.
3. Malattia attiva (ERA o JPsA) definita come aventi sia:
¿ =3 articolazioni attive (gonfie o se non gonfie devono essere sia dolenti che con limitata mobilità) alla visita baseline
¿ =1 sito di entesite attiva alla visita baseline o documentata nella storia clinica del paziente
4. Risposta inadeguata (=1 mese) o intolleranza a =1 NSAID (Non Steroidal Anti-Inflammatory Drug)
5. Risposta inadeguata (=2 mesi) o intolleranza a =1 DMARD (Disease Modifying Anti-rheumatic Drug)
6. Non è consentito l’uso concomitante di agenti di seconda linea come DMARD e/o farmaci immunosoppressori ad eccezione dei seguenti farmaci che devono rimanere a dose stabile durante i Periodi di Trattamento 1 e 2:
¿ Dose stabile di metotressato (dose massima 20mg/m2 BSA (Body Surface Area)/settimana) per almeno 4 settimane prima della visita baseline e integrazione con acido folico/folinico (secondo la pratica clinica standard del centro)
¿ Dose stabile di SSZ (Sulfalazina) (Solo per i pazienti con ERA) =50 mg/Kg/giorno e dose massima di 3000 mg/giorno per almeno 4 settimane prima della visita baseline
¿ Dose stabile di un cortisteroide orale ad una dose equivalente a =0,2mg/Kg/giorno di prednisone o fino ad una dose massima di 10 mg/giorno, l’opzione inferiore, per almeno 7 giorni prima della baseline
¿ Dose stabile di non più di 1 NSAID per almeno 1 settimana prima della baseline
7. Test QuantiFERON (QF) negativo. E’ accettabile anche test PPD (Purified protein Derivative) negativo se si tratta del test richiesto dalle linee guida locali o se il paziente ha un’età < 5 anni. La positività del test PPD viene definita come indurimento =15mm per bambini =4 anni e =10mm per bambini < 4 anni.

E.4

Principal exclusion criteria

1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.
2. Patients who have ever received biologic immunomodulating agents.
3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only).
4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.

Other protocol-defined inclusion/exclusion criteria apply.

1. Uso di farmaci sperimentali nelle 4 settimane precedenti la baseline o in un periodo dalla baseline pari a 5 volte il tempo di dimezzamento del farmaco o fino a conclusione dell’effetto farmacodinamico del farmaco, l’opzione più lunga
2. Storia di ipersensibilità al farmaco dello studio o ai relativi eccipienti o a farmaci appartenenti a classi chimico-farmacologiche simili
3. Soggetti che hanno ricevuto in qualsiasi momento rispetto all’inizio dello studio agenti immunomoodulatori biologici, inclusi ma non limitati a inibitori del TNFa (Tumor Necrosis Factor alfa), agenti di costimolazione dei linfociti T, Anti-IL-6 (interleuchina), Anti IL-1, terapie che rimuovono diverse classi di linfociti B, inclusi ma non limitati a anti CD-20 (e.g.,
alemtuzumab, anti CD-4, anti CD-5, anti CD-3, e anti CD-19), secukinumab, o altri farmaci biologici diretti verso IL-17 o il recettore per IL-17 o qualsiasi agente immunomodulante.
4. Soggetti che stanno assumendo qualsiasi DMARD non biologico ad eccezione di MTX (Metotressato) o sulfalazina (SSZ)- solo per pazienti ERA
5. Pazienti che soddisfano qualsiasi categoria diagnostica JIA della classificazione ILAR JIA che non sia ERA o JPsA
6. Pazienti che stanno assumendo farmaci proibiti dal protocollo
7. Qualsiasi terapia corticosteroidea intramuscolare/endovena/intra-articolare nelle 4 settimane prima della baseline
8. Infezione attiva batterica, fungina, virale, inclusa l’infezione da HIV(Human Imundeficiency Virus), Epatite B e Epatite C al baseline
9. Storia o evidenza di Tubercolosi attiva (TB) o evidenza di TB latente (QuantiFERON o PPD positivo allo screening) su paziente non disposto o non in grado di portare a termine una terapia per la TB latente di almeno 4 settimane prima dell’inizio della terapia con secukinumab
10. Pazienti di sesso femminile in gravidanza o allattamento, dove la gravidanza viene definita come lo stato da dopo il concepimento fino alla fine della gestazione, confermato da un test di laboratorio bHCG (human Chorionic Gonadotropin) positivo
11. Pazienti di sesso femminile (>18 anni di età) che possono rimanere incinte (che hanno già avuto la prima mestruazione o che hanno la prima mestruazione durante lo studio) che non accettano l’astinenza o, se sessualmente attive, che non accettano l’uso di un metodo di contraccezione come definito nel protocollo

E.5 End points

E.5.1

Primary end point(s)

Time to flare in Treatment Period 2

E.5.1.1

Timepoint(s) of evaluation of this end point

From Week 12 until max Week 104

E.5.2

Secondary end point(s)

Change from baseline for Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response and inactive disease status (a)

Change from baseline for each JIA ACR core component (a)

Chance from baseline Juvenile Arthritis Disease Activity Score (JADAS) score (a)

Change from baseline in total enthesitis count (a)

Change from baseline in total dactylitis count (a)

Percentage of participants with JIA ACR 30/50/70/90/100 and inactive disease (b)

Secukinumab serum concentration (c)

Number of participants with reported Adverse Events (c)

Percentage of participants with anti-secukinumab antibodies (c); Change from baseline for Juvenile idiopathic arthritis (JIA) American
college of rheumatology (ACR) 30/50/70/90/100 response and inactive
disease status (a)
Change from baseline for each JIA ACR core component (a)
Chance from baseline Juvenile Arthritis Disease Activity Score (JADAS)
score (a)
Change from baseline in total enthesitis count (a)
Change from baseline in total dactylitis count (a)
Percentage of participants with JIA ACR 30/50/70/90/100 and inactive
disease (b)
Secukinumab serum concentration (c)
Number of participants with reported Adverse Events (c)
Percentage of participants with anti-secukinumab antibodies (c)

-; Change from baseline for Juvenile idiopathic arthritis (JIA) American
college of rheumatology (ACR) 30/50/70/90/100 response and inactive
disease status (a)
Change from baseline for each JIA ACR core component (a)
Chance from baseline Juvenile Arthritis Disease Activity Score (JADAS)
score (a)
Change from baseline in total enthesitis count (a)
Change from baseline in total dactylitis count (a)
Percentage of participants with JIA ACR 30/50/70/90/100 and inactive
disease (b)
Secukinumab serum concentration (c)
Number of participants with reported Adverse Events (c)
Percentage of participants with anti-secukinumab antibodies (c)

E.5.2.1

Timepoint(s) of evaluation of this end point

(a) = 12 weeks
(b) = From week 12 to up to week 104
(c) = 104 weeks; (a) = 12 week
(b) = From week 12 to up to week 104
(c) = 104 weeks

-; (a) = 12 settimane
(b) = Dalla settimana 12 alla settimana 104
(c) = 104 settimane

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

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

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

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

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

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

Information not present in EudraCT

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

Belgium

Germany

Italy

Netherlands

Poland

Spain

Turkey

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

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

Yes

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

F.4.2.2

In the whole clinical trial

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 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.

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

2017-01-25

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

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

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