Etanercept With Tacrolimus for Psoriasis

NCT00134394 | Completed Phase 2

• 1 other identifier: 5085
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

psoriasis; tacrolimus; etanercept

Outcome Measures

Primary Outcomes (2)

• Target lesion scoring (on a scale of 0-12) at week 12

• The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.

Secondary Outcomes (3)

• Photography of target lesions

• Quarter-body photography

• Static Physician's Global Assessment (PGA) on each side of each subject's body

Interventions

Etanercept plus tacrolimus DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead

Study Sites (1)

UMDNJ Psoriasis Center of Excellence

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept; Tacrolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Macrolides; Lactones; Organic Chemicals

Study Officials

• Melissa Magliocco, MD

  UMDNJ - RWJMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: February 1, 2005
• Study Completion: December 1, 2007
• Last Updated: August 7, 2008

Record last verified: 2008-08

Locations

US (1)