psoriasis
Conditions
Interventions
Trade Name: methotrexate
Pharmaceutical Form: Tablet
Sponsors
Academic Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • 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. ;Primary end point(s): • The drug survival at one year. - Drug survival by efficacy - Drug survival by adverse events ;Timepoint(s) of evaluation of this end point: week 49;Main Objective: • 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). ;Timepoint(s) of evaluation of this end point: week 13, 25, 37 and 49 | — |
Countries
Belgium, Netherlands
Contacts
Public ContactPhyllis Ira
Department of dermatology Academic Medical Center
Outcome results
None listed