Etanercept With Tacrolimus for Psoriasis

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00134394
First received: August 22, 2005
Last updated: August 6, 2008
Last verified: August 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00134394     History of Changes
Other Study ID Numbers: 5085
Study First Received: August 22, 2005
Last Updated: August 6, 2008
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tacrolimus
TNFR-Fc fusion protein
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014