Moderate to severe psoriasis
Conditions
Interventions
adalimumab versus adalimumab plus methotrexate
Sponsors
Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
Eligibility
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.
Exclusion criteria
Exclusion criteria: -History of significant MTX or adalimumab toxicity, intolerability or contraindication -Prior treatment with adalimumab -Age < 18 years; - Known liver or kidney malfunction - Alcoholabuse -Blooddyscrasia like bonemarrowhypoplasia, leukocytopenia, thrombocytopenia or a significant anemia -Known severe or chronic infections like tuberculosis or HIV - Ulcers in the oral cavity or known active ulcers in digestive tract -Pregnant and nursing women. -Need for live vaccinations -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 |
|---|---|
| The drug survival at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| -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). | — |
Contacts
Public ContactS.P. Menting
AMC, department of dermatology A0-130 Meibergdreef 9
Outcome results
None listed