Optimising adalimumab treatment in psoriasis with concomitant methotrexate.

Phase 4

Completed

Conditions: psoriasis
10014982

Registration Number: NL-OMON45239

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following 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 (NVDV 2011);
*Willing and able to use 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

*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.)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>*The drug survival at one year. (drug survival by efficacy and drug survival by<br /><br>adverse events)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy expressed as the proportion of patients achieving PASI 75 and 90 at<br /><br>week 13, 25, 37, 49, 61, 73, 85, 97, 109, 121, 133 en 145 and reduction of<br /><br>absolute PASI at these timepoints;<br /><br>Change in PGA (patient global assessment) and IGA (investigator global<br /><br>assessment);<br /><br>Average adalimumab serum trough concentrations and ADA titers;<br /><br>Change in impact on Quality of life (Skindex 29 and DLQI);<br /><br>Occurrence of (serious) adverse events;<br /><br>Patient characteristics (age, gender, ethnicity, BMI, PsA, smoking, alcohol<br /><br>use, disease duration, disease severity by PASI, concomitant medication, naïve<br /><br>for biologics versus non-naïve (perhaps specified per biologic), trial<br /><br>medication and potential other co-variates (e.g. genetic polymorphisms).</p><br>