E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriasis Subjects with Psoriatic Arthritis |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of two different treatment regimens of etanercept in treating the skin manifestations of psoriasis subjects with PsA over 12 weeks. The study hypothesis is that etanercept 50 mg BIW will demonstrate superior clinical efficacy, as determined by the proportion of subjects achieving a Physician Global Assessment (PGA) of Psoriasis of clear or almost clear at 12 weeks, compared with etanercept 50 mg QW in the treatment of psoriasis. |
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E.2.2 | Secondary objectives of the trial |
1. To compare the efficacy of two different treatment regimens of etanercept in treating the skin manifestations over 24 weeks. 2. To compare the efficacy of two different treatment regimens of etanercept on joint disease over 12 and 24 weeks. 3. To compare the impact of two different treatment regimens of etanercept on quality of life and pharmacoeconomic outcomes over 12 and 24 weeks. 4. To evaluate the time course of treatment response to two different treatment regimens of etanercept. 5. To evaluate the safety and tolerability of two different treatment regimens of etanercept. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
These are main inclusion criteria. Please refer to the protocol for the complete list. 1. 18 years of age or older at time of consent. 2. Active PsA defined by the following criteria: • ≥(greater than or equal to) 2 swollen joints and ≥(greater than or equal to) 2 tender/painful joints at screening and baseline • Patient reported joint pain for at least 3 months prior to screening • Negative serum rheumatoid factor (within 6 months of screening) Note: A rheumatologist should establish the diagnosis of PsA if possible. Radiographs of the hands, feet, or lumbar spine/pelvis may be used to help establish the diagnosis. 3. Clinically stable, plaque psoriasis involving at least 10% body surface area (BSA) and PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline. 4. Negative serum pregnancy test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is defined as 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 5. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study. 6. Ability to self-inject drug or have a designee who can do so. 7. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. 8. Ability to store injectable test article at 2 C to 8 C.
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E.4 | Principal exclusion criteria |
These are main inclusion criteria. Please refer to the protocol for the complete list. 1. Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. 2. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive™), efalizumab (Raptiva™), anakinra (Kineret™) or any other systemic anti-psoriasis therapy within 28 days study drug initiation (Exception: methotrexate [MTX] and acitretin - see concomitant treatment section of protocol). 3. Ultraviolet B radiation (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout study). 4. Prior exposure to any TNF-inhibitor, including etanercept. 5. Corticosteroid dose of prednisone >10 mg/day (or equivalent) or change in dose within 28 days of baseline. 6. Receipt of intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid injection within 28 days of screening and during the study. 7. Dose of NSAID changed within 14 days of baseline. 8. Hot, red, joint not evaluated by a rheumatologist as PsA. 9. Abnormality in haematology or chemistry profiles: haemoglobin nmt 85 g/L; haematocrit nmt 27%; platelet count nmt 125 x 10 power 9 /L; white blood cell count nmt 3.5 x 10 power 9 /L; serum creatinine nlt 175 mmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) nlt 2 times the laboratory’s upper limit of normal. 10. Significant concurrent medical events including: · Uncontrolled hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg) · Myocardial infarction within 12 months of the screening visit · Unstable angina pectoris · Class III or IV congestive heart failure as defined by the New York Heart Association or uncompensated congestive heart failure (Hunt 2001) · Severe pulmonary disease requiring hospitalisation or supplemental oxygen · Diagnosis of multiple sclerosis or other central demyelinating diseases · Presence or history of confirmed blood dyscrasias · Uncontrolled diabetes mellitus · Rheumatoid arthritis, systemic lupus erythematosus, gout, scleroderma, or polymyositis · Cancer or history of cancer · Serious infection (infection associated with hospitalisation and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening · Open cutaneous ulcers · Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive · Tuberculosis (TB) infection (Note: follow local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy) · Any condition that, in the investigator’s judgment, might cause this study to be detrimental to the subject
11. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline. 12. Known contraindication or hypersensitivity to etanercept or its excipients. 13. Pregnant or breast-feeding women. 14. Reasonable expectation that the subject will not be able to satisfactorily complete the study. 15. History of or current psychiatric illness that would interfere with the subject’s ability to comply with protocol requirements or give informed consent. 16. History of alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements. 17. Receipt of any investigational drug within 3 months of screening visit. 18. Employment by the investigator or reporting directly or indirectly to the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving a status on the PGA of psoriasis of clear or almost clear at Week 12. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The study compares two regimens with the same IMP. |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 92 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
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 | No |
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
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This study will be completed in approximately 95 weeks: 30 week subject participation and 65 weeks (15 months) enrolment. The end of the study is the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |