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

University of California (UC) Davis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Psoriasis

Treatments: Drug: Methotrexate; Drug: Raptiva

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00368654

200513613

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

A

Active Comparator group

Description:

Monotherapy with Raptiva alone

Treatment:

Drug: Raptiva

B

Experimental group

Description:

Combination therapy with both Raptiva and Methotrexate

Treatment:

Drug: Raptiva

Drug: Methotrexate

C

Experimental group

Description:

Continue Raptiva, discontinue methotrexate

Treatment:

Drug: Raptiva

D

Experimental group

Description:

Continue combination therapy with both Raptiva and Methotrexate

Treatment:

Drug: Raptiva

Drug: Methotrexate