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

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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Raptiva; Drug: 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Chai Sue Lee, MD, University of California, Davis

Publications and helpful links

Helpful Links

• University of California-Davis Department of Dermatology Clinical Research

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: August 24, 2006
• First Submitted That Met QC Criteria: August 24, 2006
• First Posted (Estimate): August 25, 2006

Study Record Updates

• Last Update Posted (Actual): June 14, 2018
• Last Update Submitted That Met QC Criteria: May 18, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: 200513613

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No