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

Sponsor:	University of California, Davis
Collaborator:	Genentech
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00368654

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

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

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Methotrexate Efalizumab

U.S. FDA Resources

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
Study Completion Date:	May 2008
Primary Completion Date:	May 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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Univerisity of California, Davis ( Sepideh Bagheri, M.D., contact person )
Study ID Numbers:	200513613-1
Study First Received:	August 24, 2006
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00368654 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents
Pharmacologic Actions
Psoriasis
Therapeutic Uses
Abortifacient Agents
Methotrexate
Antirheumatic Agents
Dermatologic Agents
Skin Diseases, Papulosquamous
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010