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

NCT00368654 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 200513613
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events (AE)

  16 vs. 36 weeks, depending on study arm

Study Arms (4)

A

ACTIVE COMPARATOR

Monotherapy with Raptiva alone

Drug: Raptiva

B

EXPERIMENTAL

Combination therapy with both Raptiva and Methotrexate

Drug: Methotrexate; Drug: Raptiva

C

EXPERIMENTAL

Continue Raptiva, discontinue methotrexate

Drug: Raptiva

D

EXPERIMENTAL

Continue combination therapy with both Raptiva and Methotrexate

Drug: Methotrexate; Drug: Raptiva

Interventions

Methotrexate DRUG

Initial dose 5 mg, then 15 mg per week

B; D

Raptiva DRUG

Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg

Also known as: Efalizumab

A; B; C; D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of California, Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

• University of California-Davis Department of Dermatology Clinical Research

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate; efalizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chai Sue Lee
• Organization: Kaiser Permanente (Current), UC Davis (Previous)

lam.nguyen@ucdmc.ucdavis.edu

Study Officials

• Chai Sue Lee, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 25, 2006
• Study Start: January 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: June 14, 2018
• Results First Posted: June 14, 2018

Record last verified: 2018-05

Locations

US (1)