Clinical Trials Register

Summary
EudraCT Number:	2010-023802-10
Sponsor's Protocol Code Number:	B1801023
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:	2012-04-02
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

2010-023802-10

A.3

Full title of the trial

AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED
OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014)

AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014)

A.3.1

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

Study Evaluation of the Long Term Safety of Etanercept In 3 Sub-types
of Childhood Arthritis.

Studio di valutazione della sicurezza a lungo termine di etanercept in tre sottotipi di artrite giovanile.

A.3.2

Name or abbreviated title of the trial where available

Clipper 2

A.4.1

Sponsor's protocol code number

B1801023

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/236/2010

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	PFIZER INC.
B.1.3.4	Country	United States
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	Pfizer Inc.
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	Pfizer Inc.
B.5.2	Functional name of contact point	ClinicalTrials.gov Call Center
B.5.3	Address:
B.5.3.1	Street Address	235 E 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+1 800 7181021
B.5.5	Fax number	+1 303 739 1119
B.5.6	E-mail	ClinicalTrials.govCallCentrere@pfizer.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	Enbrel
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth Europa Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	Pharmaceutical form	Powder and solvent for 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	ETANERCEPT
D.3.9.1	CAS number	185243690
D.3.9.2	Current sponsor code	B1801023
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	NA
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	25
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	Yes
D.2.1.1.1	Trade name	Enbrel
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth Europa Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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	ETANERCEPT
D.3.9.1	CAS number	185243690
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	NA
D.3.9.4	EV Substance Code	SUB01984MIG
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS

Artrite oligoarticolare giovanile idiopatica, artrite associata a entesite o artrite psoriasica.

E.1.1.1

Medical condition in easily understood language

3 Sub-types of Childhood Arthritis (Extended Oligoarticular Arthritis, Enthesitis-Related Arthritis, and Psoriatic Arthritis)

3 sottotipi di artrite giovanile (artrite oligoarticolare estesa, artrite associata a entesite o artrite psoriasica).

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	LLT
E.1.2	Classification code	10059176
E.1.2	Term	Juvenile idiopathic 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 monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.

Monitorare l'insorgenza di tumori maligni in pazienti pediatrici con JIA oligoarticolare estesa, ERA, o PSA.

E.2.2

Secondary objectives of the trial

To assess the long term safety profile of etanercept.

valutare il profilo di sicurezza a lungo termine di etanercept.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Evidence of a personally signed and dated informed consent document (and assent document, as applicable) indicating that the subject (or a legally authorized representative/guardian) has been informed of all pertinent aspects of the study. 2. Subjects who are willing and able to comply with all applicable aspects of the study, including scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Receipt of at least 1 dose of investigational product and participation for approximately 96 weeks in study 0881A1 3338. 4. The subject and the parent or legally authorized representative/guardian of the subject must be able to provide contact information, including primary care physician or other treating physician.

1. Evidenza di documento di consenso informato personalmente firmato e datato (e documento di assenso, se applicabile) che indichi che il soggetto (o un rappresentante/tutore legalmente autorizzato) sia stato informato di tutti gli aspetti pertinenti allo studio. 2. Soggetti che intendano e siano in grado di ottemperare a tutti gli aspetti applicabili dello studio, comprese visite programmate, piano di trattamento, analisi di laboratorio e altre procedure dello studio. 3. Avere ricevuto almeno 1 dose di prodotto sperimentale e partecipazione per circa 96 settimane allo studio 0881A1-3338. 4. Il soggetto e il genitore o il rappresentante/tutore legalmente autorizzato del soggetto dovranno essere in grado di fornire recapiti che comprendano il medico di base o un altro medico curante.

E.4

Principal exclusion criteria

1. Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. Additional Exclusion Criteria for Subjects Planning to Continue Investigational Product - Subjects who completed approximately 96 weeks of investigational product in study 0881A1 3338 and present with any of the following will not be allowed to continue investigational product in study B1801023: 2. Withdrawal from investigational product in study 0881A1 3338 for any reason (safety or non safety). 3. History of malignancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ. 4. Participation in other clinical studies of investigational drugs or investigational combinations of approved drugs between the week 96 visit in study 0881A1 3338 and the baseline visit in study B1801023 or during participation in the active treatment period of study B1801023. 5. Pregnant or breastfeeding female subjects.

1. Soggetti facenti parte del personale del centro di sperimentazione o dipendenti di Pfizer coinvolti direttamente nella conduzione della sperimentazione. Criteri di esclusione aggiuntivi per i soggetti che prevedano di continuare il trattamento con il prodotto sperimentale Ai soggetti che abbiano completato circa 96 settimane di assunzione del prodotto sperimentale nello studio 0881A1-3338 e che presentino una delle opzioni seguenti non sarà consentito di continuare il trattamento con il prodotto sperimentale nello studio B1801023: 2. Interruzione del trattamento con il prodotto sperimentale nello studio 0881A1-3338 per qualunque motivo (sicurezza o non sicurezza). 3. Anamnesi di neoplasia maligna diversa da carcinoma basocellulare o a cellule squamose o carcinoma cervicale in situ. 4. Partecipazione ad altri studi clinici di farmaci sperimentali o combinazioni sperimentali di farmaci approvati tra la visita della settimana 96 nello studio 0881A1-3338 e la visita basale nello studio B1801023 o durante la partecipazione nel periodo di trattamento attivo dello studio B1801023. 5. Soggetti di sesso femminile incinte o in allattamento.

E.5 End points

E.5.1

Primary end point(s)

Occurrence of malignancy.

Insorgenza di neoplasie.

E.5.1.1

Timepoint(s) of evaluation of this end point

at minimum every 2 years

minimo ogni due anni

E.5.2

Secondary end point(s)

Key Secondary Endpoints for All Subjects -Occurrence of serious adverse events; -Occurrence of medically important infections (ie, an infection requiring hospitalization and /or parenteral [intravenous (IV), intra-muscular (IM)] anti infective agents).

Gli endpoint secondari chiave per tutti i soggetti sono: - Il verificarsi di eventi avversi gravi; -Insorgenza di infezioni clinicamente importanti (ad esempio, un'infezione che richiede ospedalizzazione e/o parenterale [per via endovenosa (IV), intramuscolare(IM)] agenti anti-infettivi).

E.5.2.1

Timepoint(s) of evaluation of this end point

at minimum every 2 years

minimo ogni due anni

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

E.6.7

Pharmacodynamic

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

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

Australia

Colombia

Mexico

Russian Federation

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

112

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

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)

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)

Yes

F.1.2.1

Number of subjects for this age range:

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Subject, parent or legal repr/guardian must be able to read and complete protocol specified efficacy assessments.

soggetto,genitore o legale rappr/tutore devono essere in grado di leggere e completare le valutaz di efficacia specificate nel protocollo.

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

109

F.4.2.2

In the whole clinical trial

123

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)

After subjects particpation in the trial, he/she will receive the normal standard of care for their disease.

Al termine della partecipazione allo studio essi riceveranno la terapia standard per la patologia.

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

2012-02-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-26

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

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