Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Psoriasis	Drug: Methotrexate Drug: Raptiva	Phase I Phase II

MedlinePlus related topics:

Psoriasis

ChemIDplus related topics:

Methotrexate Efalizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by University of California, Davis:

Primary Outcome Measures:

PASI -- psoriasis area and severity index [ Time Frame: 16 vs. 36 weeks, depending on study arm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

adverse events, whether or not serious [ Time Frame: 16 vs. 36 weeks, depending on study arm ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	January 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Monotherapy with Raptiva alone	Drug: Raptiva Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
B: Experimental Combination therapy with both Raptiva and Methotrexate	Drug: Methotrexate Initial dose 5 mg, then 15 mg per week Drug: Raptiva Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
C: Experimental Continue Raptiva, discontinue methotrexate	Drug: Raptiva Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
D: Experimental Continue combination therapy with both Raptiva and Methotrexate	Drug: Methotrexate Initial dose 5 mg, then 15 mg per week Drug: Raptiva Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368654

Locations


United States, California
	University of California, Davis Medical Center Department of Dermatology
	Sacramento, California, United States, 95816

Sponsors and Collaborators

University of California, Davis

Genentech

Investigators


Principal Investigator:	Chai Sue Lee, M.D.	University of California, Davis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Univerisity of California, Davis ( Sepideh Bagheri, M.D., contact person )
Study ID Numbers:	200513613-1
First Received:	August 24, 2006
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00368654
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Study placed in the following topic categories:

Folic Acid

Skin Diseases

Psoriasis

Methotrexate

Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Reproductive Control Agents

Abortifacient Agents, Nonsteroidal

Folic Acid Antagonists

Immunosuppressive Agents

Pharmacologic Actions

Therapeutic Uses

Abortifacient Agents

Antirheumatic Agents

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	University of California, Davis Genentech
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00368654