E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate to severe chronic plaque type psoriasis (Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10) who failed or have contraindications and/or are intolerant to ultraviolet therapy, methotrexate or cyclosporin.
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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 | 10050577 |
E.1.2 | Term | Psoriatic plaque |
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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 |
1. To compare clinical efficacy of etanercept and infliximab (ie, proportion of patients achieving PASI75, I-GA almost clear, clear). 2. To compare patient reported outcomes such as HRQOL, PAGA and treatment satisfaction between etanercept and infliximab. 3. To compare from a societal perspective the incremental cost effectiveness ratio of the use of etanercept versus infliximab |
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E.2.2 | Secondary objectives of the trial |
1. In (good-)responders, to compare the duration of remission. 2. In non-responders, to investigate patients perspectives of the comparative drug. 3. To compare the side-effects. 4. Subgroup analyses in relation to (cost-) effectiveness and safety, and presence of neutralising antibodies. 5. To compare the improvement of nailpsoriasis graded by the NAPSI. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
- Title: Detection and evaluation of antibody formation against biologics in psoriasis patients. - Date 22-05-2008 - Version 1.1 - Objectives: Correlation of serum trough infliximab, adalimumab, etanercept respectively efalizumab levels and antibodies to infliximab, adalimumab, etanercept respectively efalizumab with clinical response in psoriasis. |
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E.3 | Principal inclusion criteria |
- Adults patients (18-75 years of age) - Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10. - Failed, contraindicated and/or intolerant to UV therapy, methotrexate or cyclosporin. - Informed consent - Able to complete Dutch questionnaires. |
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E.4 | Principal exclusion criteria |
- Pregnancy and lactation - Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis - Malignancy in last 10 years, except BCC and cervical in situ cancer - Demyelinating disease - Congestive heart failure (NYHA grade III or IV) - Allergic and hypersensitivity reactions to study drugs or ingredients - Any live virus or bacterial vaccination within 3 months - Severe liverfunction disorders >2 times and/or kidneyfunction disorders >1,5 times upper limits of the parameters. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical efficacy and patient reported outcomes: -PASI75 at week 12 and 24. -I-GA of clinical psoriasis severity of minimal or clear. -Improvement of HRQOL: median changes in the three domain scores of the dermatology specific Skindex-17, the scores physical and mental component scale of the generic SF-36 and PAGA. -Treatment satisfaction will be measured with median changes Treatment Medication Satisfaction Questionnaire (TMSQ) score.
Economic evaluation: -The difference between the cost effectiveness of the two treatment options will be assessed. - The incremental cost effectiveness ratio (ICER) of infliximab relative to etanercept will be calculated and estimated in terms of costs per QALY. -Utilities will be assessed by using the EQ-5D. - Nonmedical costs (travel, productivity losses) and medical cost outside the hospital will be assessing using the indirect medical costs questionnaire, and the Labor and Health Questionnaire. |
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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 | No |
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) | No |
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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
blinded outcome observer for PASI, NAPSI and I-GA |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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
| 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 | 4 |
E.8.5 | The trial involves multiple Member States | No |
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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The endpoint of the trial is 24 weeks after starting with therapy. Thereafter patients will be followed every 8 weeks till week 48. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |