Psoriasis
Conditions
Interventions
Efalizumab will be administered subcutaneous (SC), with an initial dose of 0.7
mg/kg/week, followed by 1.0 mg/kg/week. MTX will be administered orally for
preference, as a weekly single dose of 15 m
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the study is the number and nature of adverse events in both treatment arms, representing treatment safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: · Mean percent reduction in PASI from baseline at week 12 · PASI50, PASI75 and PASI90 response at all visits · Changes from baseline PASI at all visits · Mean Skindex and DLQI changes at week 12 and week 24 | — |
Countries
Netherlands
Outcome results
None listed