Etanercept With Tacrolimus for Psoriasis

NCT ID: NCT00134394

Last Updated: 2008-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2007-12-31

Brief Summary

The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.

Detailed Description

The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Etanercept plus tacrolimus

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults 18 years or older with moderate to severe psoriasis, who are candidates for systemic or phototherapy, with a baseline score of 6 or higher on the target lesion score, and a baseline score of 3 or higher on the Physician's Global Assessment, on each side of the body
• Patients who are already on a stable dose of etanercept for at least 2 months and have the above criteria
• Subjects must have target lesions on each side of the body that are at least 1.5 cm in diameter and roughly symmetrical in appearance and location

Exclusion Criteria

• Inability to understand consent or comply with study requirements
• Pregnancy or unwillingness to use adequate birth control method
• Lactation
• Psoriasis plus ultraviolet A (PUVA) or systemic therapy within the past 4 weeks (other than a stable dose of Enbrel for at least 2 months)
• Ultraviolet B (UVB) or topical therapy (other than over-the-counter moisturizers) within the past 2 weeks
• Active tuberculosis or other opportunistic infection
• Demyelinating disease
• Uncontrolled congestive heart failure
• Known allergy to or any contraindications to using topical tacrolimus or etanercept
• Lack of insurance coverage or inability/refusal to pay out of pocket for etanercept and standard of care laboratory tests and PPD/CXR

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role: lead

Principal Investigators

Melissa Magliocco, MD

Role: PRINCIPAL_INVESTIGATOR

UMDNJ - RWJMS

Locations

UMDNJ Psoriasis Center of Excellence

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

5085

Identifier Type: -

Identifier Source: org_study_id