Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy

University of California, Davis12 enrolled

Overview

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 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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

MethotrexateDRUG

Initial dose 5 mg, then 15 mg per week

RaptivaDRUG

Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe plaque-type psoriasis * A candidate for systemic therapy or phototherapy * Not using prescription systemic therapies for psoriasis prior to starting the study * Not using efalizumab within 3 months prior to starting the study We are seeking adults who: * Have moderate to severe plaque-type psoriasis * Are generally healthy * Are not hypersensitive to Raptiva® (efalizumab) or any of its components. * Are not pregnant or lactating women You will: * Be interviewed and examined * Have blood drawn * Be injecting the study medication Exclusion Criteria: * Hypersensitivity to Raptiva or any of its components * Pregnant or lactating women * History of liver disease or abnormal liver enzymes * History of chronic infection or malignancy * History of significant hematologic abnormalities

Locations (1)

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, United States

Outcomes

Primary Outcomes

PASI -- Psoriasis Area and Severity Index

(PASI) - given by numerical score, the index shows the severity of psoriasis.

Time frame: 16 vs. 36 weeks, depending on study arm

Secondary Outcomes

Adverse Events (AE)

measured by whether or not AE was serious

Time frame: 16 vs. 36 weeks, depending on study arm

Data from ClinicalTrials.gov

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