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

August 22, 2005
August 6, 2008
February 2005
Not Provided
  • 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.
· 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.
Complete list of historical versions of study NCT00134394 on ClinicalTrials.gov Archive Site
  • Photography of target lesions
  • Quarter-body photography
  • Static Physician's Global Assessment (PGA) on each side of each subject's body
  • · Photography of target lesions
  • · Quarter-body photography
  • · Static Physician’s Global Assessment (PGA) on each side of each subject’s body.
Not Provided
Not Provided
 
Etanercept With Tacrolimus for Psoriasis
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis
Drug: Etanercept plus tacrolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00134394
5085
No
Not Provided
University of Medicine and Dentistry of New Jersey
Not Provided
Principal Investigator: Melissa Magliocco, MD UMDNJ - RWJMS
Rutgers, The State University of New Jersey
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP