A3921061 Long Term Safety&Tolerability of 2 oral doses of CP-690,550

• Research type

  Research Study

• Full title

  A PHASE 3, MULTI-SITE, OPEN-LABEL STUDY OF THE LONG TERM SAFETY AND TOLERABILITY OF 2 ORAL DOSES OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

• IRAS ID

  63535

• Contact name

  Anthony Bewley

• Sponsor organisation

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

• Eudract number

  2010-020002-15

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• 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 CP690, 550 by treating subjects with the drug over a long period of time (up to 4 years or until the first market approval in a global major market).Eligible subjects must have a diagnosis of plaque type psoriasis and be considered by the Investigator's a candidate for systemic therapy or phototherapy. Patients entering this study will have previously participated in study A3921111.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 (if applicable) or their first baseline visit for this study will be completed at the same time as their end of study visit for protocol A3921111.The objectives will be assessed throughout the study by Physician assessments of the patients psoriasis, and subjects assessments of outcomes by completing questionnaires related to Psoriasis and quality of life, physical examinations, vital signs, electrocardiograms, chest x-rays and blood tests. Subjects will be randomised to receive either CP690,550 10mg twice a day for the first 3 months and then the dose can be decreased to 5mg twice a day at the Investigators discretion or based on any safety abnormalities. Subjects will remain in the study for up to 3 years. Subjects who complete the treatment period or withdraw from the study prior to completion will have a follow up visit completed 2 to 4 weeks after their final study visit.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  10/H0703/107

• Date of REC Opinion

  25 Feb 2011

• REC opinion

  Further Information Favourable Opinion