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

Phase 1

Completed

• Conditions: Psoriasis
• Interventions: Drug: Methotrexate; Drug: Raptiva

• Registration Number: NCT00368654
• Lead Sponsor: University of California, Davis

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 Timeline

• Study First Submitted: 2006-08-24
• Study First Submitted QC: 2006-08-24
• Study First Posted: 2006-08-25
• Study Start: 2007-01
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2017-12-11
• Status Verified: 2018-05
• Results First Submitted QC: 2018-05-18
• Last Update Submitted: 2018-05-18
• Results First Posted: 2018-06-14
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Methotrexate	Combination therapy with both Raptiva and Methotrexate
A	Raptiva	Monotherapy with Raptiva alone
B	Raptiva	Combination therapy with both Raptiva and Methotrexate
C	Raptiva	Continue Raptiva, discontinue methotrexate
D	Methotrexate	Continue combination therapy with both Raptiva and Methotrexate
D	Raptiva	Continue combination therapy with both Raptiva and Methotrexate

Primary Outcome Measures

Name	Time	Method
PASI -- Psoriasis Area and Severity Index	16 vs. 36 weeks, depending on study arm	(PASI) - given by numerical score, the index shows the severity of psoriasis.

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AE)	16 vs. 36 weeks, depending on study arm	measured by whether or not AE was serious

Trial Locations

Locations (1)

University of California, Davis Medical Center Department of Dermatology; 🇺🇸 Sacramento, California, United States