Clinical trial NCT00368654: Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
Official title: An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2006-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: PASI -- Psoriasis Area and Severity Index
timeFrame: 16 vs. 36 weeks, depending on study arm
Secondary outcomes:
measure: Adverse Events (AE)
timeFrame: 16 vs. 36 weeks, depending on study arm
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Medical Center Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Chai Sue Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: