University of California, Davis Medical Center Department of Dermatology
Sacramento, California, 95816, United States
NCT Number: NCT00368654
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Sacramento, California, 95816, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
We are seeking adults who:
You will:
Exclusion criteria
Initial dose 5 mg, then 15 mg per week
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Other names: Efalizumab
Time frame: 16 vs. 36 weeks, depending on study arm
(PASI) - given by numerical score, the index shows the severity of psoriasis.
Time frame: 16 vs. 36 weeks, depending on study arm
measured by whether or not AE was serious
University of California, Davis
Other
An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy
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