Optimising adalimumab treatment in psoriasis with concomitant methotrexate.
Recruiting
- Conditions
- Moderate to severe psoriasis
- Registration Number
- NL-OMON24479
- Lead Sponsor
- Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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;
Exclusion Criteria
-History of significant MTX or adalimumab toxicity, intolerability or contraindication
-Prior treatment with adalimumab
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The drug survival at one year.
- Secondary Outcome Measures
Name Time Method -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; <br>-Change in PGA (patient global assessment) and IGA (investigator global assessment); <br>-Average adalimumab serum trough concentrations and ADA titers; <br>-Change in impact on Quality of life (Skindex 29 and DLQI); <br>-Treatment satisfaction (measured by TSQM); <br>-Occurrence of (serious) adverse events; <br>-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). <br>