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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Collaborator: Genentech, Inc.
• Treatments: Antibodies, Monoclonal; Methotrexate

Criteria

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