A3921111 Withdrawal and Re-treatment with CP-690,550 in Psoriasis

• Research type

  Research Study

• Full title

  A PHASE 3, MULTI-SITE, RANDOMIZED, MIXED-BLIND, PARALLEL-GROUP TREATMENT WITHDRAWAL AND RE-TREATMENT STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

• IRAS ID

  63391

• Contact name

  Anthony Bewley

• Sponsor organisation

  Pfizer Inc.235 East 42nd Street, New York, NY 10017

• Eudract number

  2010-020005-32

• ISRCTN Number

  ISRCTN

• Research summary

  This research study involves subjects with moderate to severe chronic plaque psoriasis. Psoriasis is a skin disease that causes itchy or sore patches of thick, red skin with silvery scales. The goal of psoriasis treatment is to control symptoms and prevent infections. The main purpose of this study is to continue to learn about the experimental drug CP-690,550 by treating subjects with the drug then withdrawing or continuing treatment for up to 16 weeks and then all subjects will be re-treated with the drug. Eligible subjects must have a diagnosis of plaque-type psoriasis for at least 12 months before the first dose of study drug. Subjects will sign an informed consent form before any tests are done. Each subject's suitability for the study will be assessed during a screening visit.T he objectives will be assessed throughout the study by physical examinations, blood tests, electrocardiograms, Chest X-rays, physician assessments of psoriasis and subjects assessments of outcomes by completing questionnaires related to Psoriasis and quality of life. Subjects will be randomised to receive either CP-690,550 5mg or 10mg during period A. They will then be randomised again at week 24 (Period B) to receive either CP-690,550 (5mg or 10mg) or matching placebo. Subjects will remain on this treatment or placebo for a maximum of 16 weeks when they will then re-start (Period C) on either 5mg or 10mg of CP-690,550 (if receiving placebo in period B)or will continue on the same dose in Period C through to week 56.Subjects will remain in the study for up to 56 weeks. Subjects who either complete the treatment period or withdraw from the study prior to completion may be eligible to enter a long term study of CP-690,550. Subjects who do not enter this study will have follow up visit completed 2 to 4 weeks after their final study visit.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/92

• Date of REC Opinion

  8 Feb 2011

• REC opinion

  Further Information Favourable Opinion