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

Study Overview
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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.

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

Official Title
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An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Raptiva


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Monotherapy with Raptiva alone | Drug: Raptiva<br>* Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg<br>* Other names: Efalizumab;|
| Experimental: B<br>Combination therapy with both Raptiva and Methotrexate | Drug: Methotrexate<br>* Initial dose 5 mg, then 15 mg per week<br>Drug: Raptiva<br>* Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg<br>* Other names: Efalizumab;|
| Experimental: C<br>Continue Raptiva, discontinue methotrexate | Drug: Raptiva<br>* Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg<br>* Other names: Efalizumab;|
| Experimental: D<br>Continue combination therapy with both Raptiva and Methotrexate | Drug: Methotrexate<br>* Initial dose 5 mg, then 15 mg per week<br>Drug: Raptiva<br>* Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg<br>* Other names: Efalizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PASI -- Psoriasis Area and Severity Index | (PASI) - given by numerical score, the index shows the severity of psoriasis. | 16 vs. 36 weeks, depending on study arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AE) | measured by whether or not AE was serious | 16 vs. 36 weeks, depending on study arm |