Clinical Trials Register

Summary
EudraCT Number:	2009-012520-84
Sponsor's Protocol Code Number:	0881A1-3338-WW
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:	2010-01-28
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

2009-012520-84

A.3

Full title of the trial

A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

0881A1-3338-WW

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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*BB SC 4FL 25MG 1ML+4SIR
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH LEDERLE SpA
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.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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.3.10	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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

Extended Oligoarticular Juvenile Idiopathic Arthritis (JIA) Enthesitis-Related Arthritis (ERA) Psoriatic Arthritis (PsA)

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10003246

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA. Part 2: To assess the long-term safety of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA.

E.2.2

Secondary objectives of the trial

Part 1: To assess the effect of etanercept on safety and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA. Part 2: To assess the effect of etanercept on clinical benefit and physical functioning in subjects with extended oligoarticular JIA, ERA, or PsA.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1.Male and female subjects must have met ILAR criteria for diagnosis of 1 of the following JIA subtypes (see Attachment 1 for ILAR criteria) before the screening visit and must be within the specified age range at the time of the screening visit: extended oligoarticular JIA between the ages of 2 and 17 years. ERA between the ages of 12 and 17 years. PsA between the ages of 12 and 17 years. 2.At both the screening and baseline visits, the following criteria must be met for the relevant JIA subtype: Extended oligoarticular JIA: ≥ 2 active joints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness). A history of intolerance or an unsatisfactory response to at least a 3-month course of at least 1 disease-modifying antirheumatic drug (DMARD) at an adequate dose. PsA: ≥ 2 active joints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness). A history of intolerance or an unsatisfactory response to at least a 3-month course of at least 1 DMARD at an adequate dose. ERA: 2 active joints (swollen or, in the absence of swelling, limited range of motion accompanied by either pain or tenderness) A history of intolerance or an unsatisfactory response to at least 1 of the following: at least a 1-month course of at least 1 nonsteroidal anti-inflammatory drug (NSAID) at an adequate dose OR at least a 3-month course of at least 1 DMARD at an adequate dose. 3.Subjects taking hydroxychloroquine, sulphasalazine, or methotrexate (MTX) must have been receiving these for at least 3 months before the baseline visit. Only 1 DMARD is to be taken throughout the study and the dose must be held stable for at least 8 weeks before the baseline visit. 4.All male and female subjects who, in the opinion of the investigator are biologically capable of having children, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 30 days after the last dose of investigational product. Female subjects who, in the opinion of the investigator, are biologically capable of having children must have a negative urine pregnancy test at screening and baseline (day 1) before administration of investigational product. 5.Either the subject or an available adult must be capable (according to the investigators judgment) of reconstituting and administering injections of subcutaneous (SC) etanercept. 6.The parent or legally authorized representative/guardian of the subject must be able to read and complete the protocol-specified efficacy assessments.

E.4

Principal exclusion criteria

1.Subjects with systemic JIA, persistent oligoarticular JIA, polyarticular JIA, or undifferentiated arthritis per ILAR criteria. 2.Subjects positive for HLA-B27 (PsA and extended oligoarticular subtypes only) or immunoglobulin M (IgM) rheumatoid factor (RF) at the screening visit. 3.Subjects with active uveitis within 6 months of the baseline visit. 4.Subjects with other rheumatic diseases including but not limited to Lyme disease, systemic lupus erythematosus, systemic vasculitis, polymyositis, infectious or reactive arthritis, overlap syndrome (eg, Sharps syndrome), or Reiters syndrome. 5.Subjects with guttate, pustular, or erythrodermic psoriasis. 6.Prior treatment with any biologic drugs, including TNF inhibitors, abatacept, rituximab, and tocilizumab. 7.Receipt within 6 months before the baseline visit: Immunosuppressive drugs (excluding corticosteroids) (eg, cyclophosphamide). Leflunomide. 8.Receipt within 3 months before the baseline visit: Nonbiologic DMARDs other than hydroxychloroquine, sulphasalazine, MTX, or those not listed under other exclusion criteria. Any investigational nonbiologic drugs or devices. Any live (attenuated) vaccines. 9.Receipt within 4 weeks before the baseline visit: Ultraviolet A (UVA), ultraviolet B (UVB), or psoralen + UVA (PUVA) therapy for psoriatic lesions. 10.Receipt within 2 weeks before the baseline visit: More than 1 NSAID, or a change in the dose or type of the NSAID, or an NSAID dose greater than the maximum recommended dose. More than 0.2 mg/kg/day or > 10 mg/day, whichever is less, of oral prednisone or equivalent, or a change in the dose of prednisone or its equivalent. Receipt of intra-articular or soft tissue corticosteroid injection or bolus intramuscular (IM) or intravenous (IV) treatment with corticosteroids. Topical steroids, oral retinoids, topical vitamin A or D analog preparations or anthralin for psoriatic lesions (exception topical therapies are permitted on the scalp, axillae, and groin at low to moderate strength; the dose and type must be held stable for at least 2 weeks before the baseline visit). 11.Any major illness/condition or evidence of unstable clinical condition (eg, cardiovascular [including congestive heart failure], cerebrovascular, neurologic, metabolic, immunologic, infectious, hepatic, renal condition, uncontrolled diabetes mellitus or hypertension), or any serious disorder (eg, current or history of alcohol or drug abuse, current or history of psychiatric disease) that, in the investigators judgment, will substantially increase the risk associated with the subjects participation in and completion of the study, or could preclude the evaluation of the subjects response, or interfere with the subjects ability to give informed consent. 12.Pregnant or breastfeeding female subjects. 13.Cancer or history of cancer. 14.History of blood dyscrasias. 15.History of Macrophage Activating Syndrome (MAS). 16.History of demyelinating diseases (eg, multiple sclerosis or optic neuritis). 17.Documented immunodeficiency disease, including subjects with known human immunodeficiency virus (HIV) at the time of the screening visit. 18.Positive for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), and/or hepatitis C virus (HCV). 19.History of drug-induced liver injury, liver cirrhosis or fibrosis at any time before the baseline visit. 20.Any of the following laboratory abnormalities at screening: a.Hemoglobin < 8.5 g/dL (SI units: < 85 g/L) b.White blood cell (WBC) count < 3.50 x 103/mm3 (SI units: < 3.50 x 109/L) and neutrophils < 1 x 109 /L c.Platelets < 125,000/mm3 or ≥ 1,000,000/mm3 (SI units: < 125 x 109/L or ≥ 1,000 x 109/L) d.Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) > 1.5 x upper limit of normal (ULN) Screening laboratory tests with abnormal results ...

E.5 End points

E.5.1

Primary end point(s)

Evaluation of Clinical Benefit in the Combined Population: The main endpoint for the combined population is the proportion of subjects meeting the American College of Rheumatology (ACR) Pediatric 30 (Pedi 30) criteria at week 12, defined as > 30% improvement in at least 3 of 6 of the following variables: 1.Physicians Global Assessment (PGA) of Disease Activity on a 21-circle visual analogue scale (VAS) 2.Parent/Patient Global Assessment on a 21-circle VAS 3.Childhood Health Assessment Questionnaire (CHAQ) 4.Number of active joints (defined as joints that are swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness) 5.Number of joints with limited range of motion 6.Laboratory measure of inflammation (CRP) With worsening > 30% in no more than 1 of these variables. Additional assessments of clinical benefit in the combined population will be assessed at screening, baseline, weeks 4, 8, 12, 24, 36, 48, 60,72, 84, and 96, or upon early withdrawal, unless otherwise indicated: ACR Pedi 30 at all timepoints other than week 12 ACR Pedi 50, 70, 90, and 100 Individual components of the ACR Pedi 30 Pain Assessment on a 21-circle VAS Duration of morning stiffness Disease status, where inactive disease is defined as no joints with active arthritis, a normal CRP, and a PGA of disease activity of 0 on a 21-circle VAS.

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

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

Yes

E.6.13.1

Other scope of the trial description

Immunogenicita`: per verificare la presenza di anticorpi anti-etanercept

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

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.8.3

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

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

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.1.1.6

Adolescents (12-17 years)

Yes

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

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

minori di 18 anni

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

100

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

2010-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-12-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-01-30

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