E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with moderate-to-severe psoriasis. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with moderate-to-severe psoriasis. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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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 |
- The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization (non-inferiority of intervention) - Optimization of extraction protocol for adalimumab serum trough levels and anti-drug antibodies (ADA) derived from micro-sampling technique.
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E.2.2 | Secondary objectives of the trial |
- The proportion of patients in each group who relapses [defined as the need for dose escalation (not in the standard based dosing arm)] - The proportion of patients in each group with serum trough levels (Ctrough) of adalimumab within the optimal interval - The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab (ADA positivity) - Evaluation of the cost-effectiveness of the intervention - Recording of demographic parameters during disease course monitored at baseline and at every visit (reflected by incidence, prevalence, mortality, standardized comorbidity incidence ratios and associations/risk factors) - Quality adjusted life years (QALY) - Determine inter- and intrapatient variability (IPV) - HRQoL EQ-5D-5L
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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 |
In addition, to be able to build a PK(PD) model for adalimumab, additional data points will be needed (weekly sampling). Herefore, twenty patients will be selected and asked for their informed consent from each study arm and additional blood samples will be taken (weekly) by micro-sampling technique. |
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E.3 | Principal inclusion criteria |
1. Participants must be >18 years of age. 2. Participants must have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without PsA), prior to inclusion. 3. Participant must remain on a highly effective method of birth control during the study or during the entire treatment with adalimumab (whether with is longer) 4. Participants must agree not to receive a live virus or live bacterial vaccination at least 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention (except for varicella and MMR vaccines), during the study, or within 3 months after the last administration of study intervention. 5. Participants must avoid prolonged sun exposure and use of tanning booths or other ultraviolet light sources during study . 6. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
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E.4 | Principal exclusion criteria |
1. Participants who have currently a predominant nonplaque forms of psoriasis (e.g. Erythrodermic, guttate, pustular) 2. Participants who are pregnant, nursing or planning a pregnancy or fathering a child while enrolled in the study or within 12 weeks after receiving the last administration of study intervention 3. Participants who have received, or are expected to receive, any live virus or bacterial vaccination (with the exception of varicella or MMR vaccines) within 3 months (or longer as indicated in the package insert of the relevant vaccine) prior to the first administration of study intervention, during the study, or within 12 weeks after the last administration of study intervention 4. Participants who have known allergies, hypersensitivity or intolerance to adalimumab or its excipients 5. Participants who are unable or unwilling to undergo multiple venapunctures
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E.5 End points |
E.5.1 | Primary end point(s) |
absolute PASI < 2 (clinical remission) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
over the course of 48 weeks |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
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 | Yes |
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 | 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 |
same product, but administration of dosage according to the summary of product characteristics |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | 6 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |