Status:

COMPLETED

An Efficacy and Safety Study of CNTO 1275 Compared to Etanercept in Patients With Plaque Psoriasis

Lead Sponsor:

Centocor, Inc.

Conditions:

Psoriasis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.

Detailed Description

This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in ...

Eligibility Criteria

Inclusion

  • Have had a diagnosis of plaque-type psoriasis at least 6 months prior to the study
  • Have plaque-type psoriasis covering at least 10 percentage of total body surface area
  • Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater and a Physician's Global Assessment (PGA) score of 3 or greater at the time of the first administration of study drug
  • Must be suitable for phototherapy or systemic treatment for psoriasis
  • Have failed to respond to or have condition which prevents use of cyclosporine, methotrexate (MTX) or psoralen plus ultraviolet light A (PUVA)

Exclusion

  • Currently have nonplaque forms of psoriasis
  • Have current drug-induced psoriasis
  • Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or IL-23 (Interleukins are the substance produced by body in immunological disease like psoriasis)
  • Have received phototherapy or any systemic medications/treatments that could affect psoriasis or PASI evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of study agent
  • Have used a biologic within the previous 3 months

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2009

Estimated Enrollment :

903 Patients enrolled

Trial Details

Trial ID

NCT00454584

Start Date

March 1 2007

End Date

January 1 2009

Last Update

November 21 2012

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