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

Tracking Information

First Received Date ^ICMJE

August 24, 2006

Last Updated Date

May 7, 2009

Start Date ^ICMJE

January 2007

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy.

Change History

Complete list of historical versions of study NCT00368654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Psoriasis

Intervention ^ICMJE

Drug: Methotrexate
Drug: Raptiva

Study Arms / Comparison Groups

Active Comparator: Monotherapy with Raptiva alone
Experimental: Combination therapy with both Raptiva and Methotrexate
Experimental: Continue Raptiva, discontinue methotrexate
Experimental: Continue combination therapy with both Raptiva and Methotrexate

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00368654

Responsible Party

Sepideh Bagheri, M.D., contact person, Univerisity of California, Davis

Study ID Numbers ^ICMJE

200513613-1

Study Sponsor ^ICMJE

University of California, Davis

Collaborators ^ICMJE

Genentech

Investigators ^ICMJE

Principal Investigator:

Chai Sue Lee, M.D.

University of California, Davis

Information Provided By

University of California, Davis

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP