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Etanercept With Tacrolimus for Psoriasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134394
First Posted: August 24, 2005
Last Update Posted: August 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rutgers, The State University of New Jersey
  Purpose
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.

Condition Intervention Phase
Psoriasis Drug: Etanercept plus tacrolimus Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Bilateral Comparison of Topical Tacrolimus 0.1% vs. Placebo Ointment as Adjunctive Therapy for Patients With Moderate to Severe Psoriasis Who Are Candidates for or Poor Responders to Etanercept Therapy

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Photography of target lesions
  • Quarter-body photography
  • Static Physician's Global Assessment (PGA) on each side of each subject's body

Estimated Enrollment: 20
Study Start Date: February 2005
Estimated Study Completion Date: December 2007
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134394


Locations
United States, New Jersey
UMDNJ Psoriasis Center of Excellence
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Melissa Magliocco, MD UMDNJ - RWJMS
  More Information

ClinicalTrials.gov Identifier: NCT00134394     History of Changes
Other Study ID Numbers: 5085
First Submitted: August 22, 2005
First Posted: August 24, 2005
Last Update Posted: August 7, 2008
Last Verified: August 2008

Keywords provided by Rutgers, The State University of New Jersey:
psoriasis
tacrolimus
etanercept

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tacrolimus
Etanercept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents