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.1.2 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 |
• 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 significantly improves long-term drug survival compared to adalimumab monotherapy;
• To assess if combination therapy of adalimumab and MTX improves the efficacy compared to adalimumab monotherapy at week 13, 25, 37, 49 and every 12 weeks until study completion (week 145);
• 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 week 13, 25, 37 and 49 and every 12 weeks until study completion (week 145);
• To compare Quality of Life and between the combination (adalimumab and MTX) and the monotherapy (adalimumab) group at week 13, 25, 37, 49 weeks and every 12 weeks until study completion (week 145);
• To assess the tolerability and safety of the combination therapy compared to the monotherapy group;
• (see below) ... |
• To determine the correlation of certain patient characteristics like age, gender, ethnicity, BMI, PsA, smoking, alcohol use, disease duration, disease severity by
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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 |
week 13, 25, 37 and 49 and every 12 weeks until study completion (week 145) |
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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 standard 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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 |