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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00368654
• Other study ID #: 200513613
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Methotrexate
Initial dose 5 mg, then 15 mg per week
• Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

Locations

Country	Name	City	State
United States	University of California, Davis Medical Center Department of Dermatology	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Events (AE)	measured by whether or not AE was serious	16 vs. 36 weeks, depending on study arm

External Links

•   University of California-Davis Department of Dermatology Clinical Research