Safety and efficacy of efalizumab in combination with methotrexate in patients with severe psoriasis: a comparative study.
Phase 4
- Conditions
- Psoriasis10014982
- Registration Number
- NL-OMON31349
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
- Patients must be older than 18 years of age.
- Patients must have a PASI greater than 10, or a PASI greater than 8 in combination with a Skindex-29 > 35.
- Patients must have failed to respond to phototherapy, methotrexate and/or cyclosporin in the past or have a contraindication for using phototherapy or cyclosporin.
Exclusion Criteria
- Patients who have non-plaque forms of psoriasis (eg, erythrodermic, guttate or pustular).
- Patients who have current drug-induced psoriasis.
- Female patients who are pregnant, nursing and both men and women who are planning pregnancy during the study period or during the six months after receiving the last dose of study medication.
- Patients with severe other diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint for the study is the number and nature of adverse events<br /><br>in both treatment arms, representing treatment safety. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints are:<br /><br>· Mean percent reduction in PASI from baseline at week 12<br /><br>· PASI50, PASI75 and PASI90 response at all visits<br /><br>· Changes from baseline PASI at all visits<br /><br>· Mean Skindex and DLQI changes at week 12 and week 24</p><br>