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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Psoriasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Monotherapy with Raptiva alone

Group Type ACTIVE_COMPARATOR

Raptiva

Intervention Type DRUG

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

B

Combination therapy with both Raptiva and Methotrexate

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Initial dose 5 mg, then 15 mg per week

Raptiva

Intervention Type DRUG

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

C

Continue Raptiva, discontinue methotrexate

Group Type EXPERIMENTAL

Raptiva

Intervention Type DRUG

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

D

Continue combination therapy with both Raptiva and Methotrexate

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Initial dose 5 mg, then 15 mg per week

Raptiva

Intervention Type DRUG

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

Interventions

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Methotrexate

Initial dose 5 mg, then 15 mg per week

Intervention Type DRUG

Raptiva

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

Intervention Type DRUG

Other Intervention Names

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Efalizumab

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes