Conditions: Psoriasis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 12
Healthy volunteers: yes

Brief summary:
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

Detailed description:
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.

The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly

Arms:
arm 1: Monotherapy with Raptiva alone arm 2: Combination therapy with both Raptiva and Methotrexate arm 3: Continue Raptiva, discontinue methotrexate arm 4: Continue combination therapy with both Raptiva and Methotrexate

Interventions: intervention 1: Methotrexate intervention 2: Raptiva
Intervention descriptions: intervention 1: Initial dose 5 mg, then 15 mg per week intervention 2: Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

Protocol document: