Clinical Trials Register

Summary
EudraCT Number:	2005-005936-29
Sponsor's Protocol Code Number:	0881A6-318-EU
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2006-05-12
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

Netherlands - Competent Authority

A.2

EudraCT number

2005-005936-29

A.3

Full title of the trial

A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis

A.4.1

Sponsor's protocol code number

0881A6-318-EU

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
B.Sponsor: 2
B.1.1	Name of Sponsor	Wyeth Pharmaceuticals France, Wyeth Research Division
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor
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	Information not present in EudraCT
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	Netherlands
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	etanercept
D.3.2	Product code	0881
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.3.9.2	Current sponsor code	0881
D.3.9.3	Other descriptive name	TNR-001, TNFR:FC
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	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)	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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	Yes
D.3.11.13.1	Other medicinal product type	Human tumour necrosis factor receptor p75 fusion protein produced by recombinant DNA technology.

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	Powder and solvent for 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

moderate to severe plaque psoriasis

MedDRA Classification

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 assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

E.2.2

Secondary objectives of the trial

to evaluate the quality of life, pharmacokinetics as well as the open-label safety and efficacy of etanercept administered once weekly for up to 24 weeks.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

1. Adults ≥ 18 years of age with clinically stable plaque psoriasis involving ≥ 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening.
2. Failure to respond to, or have a contraindication to, or intolerance to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: · Methotrexate (MTX) · Acitretin· Cyclosporine
· Ultraviolet A (UVA)· Ultraviolet B (UVB)· Psoralen and ultraviolet A (PUVA)· Fumarate
3. Negative serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test taken at screening or baseline for all women, except those who are surgically sterile or at least 1 year postmenopausal.
4. Sexually active women of childbearing potential and sexually active men participating in the study must use a medically acceptable form of contraception. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
5. Subject or designee must have the ability to reconstitute and inject test article subcutaneously.
6. Subject is capable of understanding and giving written, voluntary informed consent before study screening.
7. Ability to store injectable test article at 2°C to 8°C.

E.4

Principal exclusion criteria

1. Previous treatment with etanercept, antibody to TNFa, or other TNFa inhibitors.
2. Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline visit.
3. Serious infection (requiring parenteral antibiotic and/or hospitalization) within one month prior to screening or baseline visit.
4. Abnormality in hematology or chemistry profiles at screening or baseline visit: alanine transaminase (ALT) and aspartate transaminase (AST) ≥ 2 x the upper limit of normal: hemoglobin ≤ 85 g/L (8.5 g/dL); platelet count ≤ 125 x109/L (125,000 cells/mm3); white blood cell count ≤ 3.5 x109/L (3,500 cells/mm3); serum creatinine ≥ 177 µmol/L (2 mg/dL).
5. Evidence of skin conditions at the time of the screening or baseline visit (eg, eczema) that would interfere with evaluations of the effect of test article on psoriasis.
6. Receipt of any investigational drug(s) within 3 months of baseline visit.
7. Receipt of any live (attenuated) vaccine within one month prior to baseline visit.
8. Receipt of alefacept, efalizumab, anti-CD4 agents, and diphtheria IL-2 fusion protein 6 months prior to baseline visit.
9. PUVA, UVA, or UVB therapy one month prior to baseline visit.
10. Receipt of any systemic psoriasis therapy (including methotrexate) or oral or parenteral corticosteroids one month prior to baseline visit.
11. Topical steroids, topical vitamin A or D analog preparations or anthralin 2 weeks prior to baseline visit (exception – topical steroids at no higher than moderate strength are permitted on the scalp, axillae, groin, but dose and brand must be kept constant for the duration of part A).
12. Topical cyclosporine, pimecrolimus, and tacrolimus, or calcineurin inhibitors 2 weeks prior to baseline visit.
13. Body mass index > 38 (see attachment)
14. Pregnant or breast-feeding women.
15. Abnormal or clinically significant chest radiograph within 12 months of the screening visit.
16. Significant concurrent medical conditions at the time of screening or baseline including:· Presence of active infection or any underlying diseases that could predispose subjects to infections.· Uncontrolled hypertension (defined as screening systolic blood pressure measurement of greater than 180 mm Hg or screening diastolic blood pressure of greater than 110 mm Hg).· Myocardial infarction less than one year prior to baseline visit.· Unstable angina pectoris within 6 months of baseline visit.· Class III or IV congestive heart failure as defined by the New York Heart Association10(see attachment).· Severe pulmonary disease requiring hospitalization or supplemental oxygen therapy.· Diagnosis of multiple sclerosis or any other demyelinating disease.· Uncontrolled insulin-dependent diabetes mellitus.· Any rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma, polymyositis, or associated syndromes.· Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma).· Open cutaneous ulcers.· Active tuberculosis (follow your country’s guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy).· Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive.· Any condition that, in the judgment of the investigator, might cause this study to be detrimental to the subject.
17. Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or give informed consent.
18. History of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
19. Employment by the investigator or reporting directly or indirectly to the investigator.

E.5 End points

E.5.1

Primary end point(s)

The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.

The secondary efficacy endpoints will include but not limited to:
· PASI 50
· PASI 75 (at visit other than week 12)
· PASI 90
· PASI score
· PGA of 0 or 1 (clear or minimal)
· PGA of 0, 1, 2 (clear, minimal, mild)
· PGA
· Patient global assessment of Psoriasis
· DLQI score
· DLQI response (proportion of subjects with a DLQI score of 0 or with an improvement of greater than or equal 5 points from baseline)
· FACIT-F response (proportion of subject with improvement of greater than or equal 3 points from baseline)
· FACIT-F score·
EQ-5D score

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

Information not present in EudraCT

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

Yes

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

The study has 2 parts: part A 12-week double-blind and part B 12-week open label.

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.8.3

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.8.5

The trial involves multiple Member States

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Information not present in EudraCT

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

The end of the study is the last visit (follow-up) of the last subject.

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 months

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Information not present in EudraCT
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-12.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1	In the member state	12
F.4.2	For a multinational trial
F.4.2.1	In the EEA	120
F.4.2.2	In the whole clinical trial	120

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

2006-05-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-08-03

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2007-05-07

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