E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
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 assess if combination therapy of adalimumab and MTX significantly improves the drug survival at one year compared to adalimumab monotherapy in patients with moderate-to-severe psoriasis. |
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E.2.2 | Secondary objectives of the trial |
• To assess if combination therapy of adalimumab and MTX improves the efficacy at 13, 25, 37 and 49 weeks compared to adalimumab monotherapy;
• To assess if combination therapy of adalimumab and MTX leads to a higher average adalimumab trough concentration and lower ADA titers compared with adalimumab monotherapy at 13, 25, 37 and 49 weeks;
• To compare Quality of Life and treatment satisfaction between the combination (adalimumab and MTX) and the monotherapy (adalimumab) group at 13, 25, 37 and 49 weeks;
• To assess the tolerability and safety of the combination therapy compared to the monotherapy group;
• To determine the correlation of certain patient characteristics like age, gender, ethnicity, BMI, PsA, smoking, alcohol use, disease duration, disease severity by PASI, concomitant medication, naïve for biologics versus non-naïve (perhaps specified per biologic), trial medication and potential other co-variates (e.g. genetic polymorphisms) with other endpoints.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Have a diagnosis of moderate to severe plaque psoriasis (PASI≥8 at time of screening);
• Is a candidate for the treatment with biologic drugs according to the pertaining guidelines;
• Willing and able to use an adequate contraceptives during the study (all men and pre-menopausal women);
• Adalimumab therapy will be started for the treatment of psoriasis
• Signed informed consent.
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E.4 | Principal exclusion criteria |
• History of significant MTX or adalimumab toxicity, intolerability or contraindication
• Prior treatment with adalimumab
• Age < 18 years;
• Pregnant and nursing women.
• -other immunosuppressive medication (prednisone, mycofenolaatmofetyl (Cellcept e.g.), ciclosporine (Neoral e.g.), sirolimus (Rapamune), systemic tacrolimus (Prograft e.g.) e.g.)
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E.5 End points |
E.5.1 | Primary end point(s) |
• The drug survival at one year.
- Drug survival by efficacy
- Drug survival by adverse events
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Efficacy expressed as the proportion of patients achieving PASI 75 and 90 at week 13, 25, 37 and 49 and reduction of absolute PASI at these timepoints;
• Change in PGA (patient global assessment) and IGA (investigator global assessment);
• Average adalimumab serum trough concentrations and ADA titers;
• Change in impact on Quality of life (Skindex 29 and DLQI);
• Treatment satisfaction (measured by TSQM);
• Occurrence of (serious) adverse events;
• Patient characteristics (age, gender, ethnicity, BMI, PsA, smoking, alcohol use, disease duration, disease severity by PASI, concomitant medication, naïve for biologics versus non-naïve (perhaps specified per biologic), trial medication and potential other co-variates (e.g. genetic polymorphisms).
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | 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 |
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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 |
adalimumab with methotrexate is compared to adalimumab monotherapy |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 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 | |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 36 |