Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
Information source: University of California, Davis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Methotrexate (Drug); Raptiva (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: University of California, Davis Official(s) and/or principal investigator(s):
Chai Sue Lee, M.D., Principal Investigator, Affiliation: University of California, Davis
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.
Clinical Details
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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: PASI -- psoriasis area and severity index
Secondary outcome: adverse events, whether or not serious
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
University of California, Davis Medical Center Department of Dermatology, Sacramento, California 95816, United States
Additional Information
Starting date: January 2007
Ending date: December 2008
Last updated: June 4, 2008
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