A3921080 Use of CP-690,550 & Etanercept in Plaque Psoriasis

• Research type

  Research Study

• Full title

  A PHASE 3, MULTI-SITE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF THE EFFICACY AND SAFETY OF 2 ORAL DOSES OF CP-690,550 AND 1 SUBCUTANEOUS DOSE OF ETANERCEPT IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

• IRAS ID

  89398

• Contact name

  Anthony Bewley

• Sponsor organisation

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

• Eudract number

  2010-020004-30

• ISRCTN Number

  n/a

• Research summary

  The study drug is CP-690,550 (Tasocitinib) & this is being developed for oral treatment in patients with moderate to severe plaque psoriasis. Effective results have already been demonstrated in two studies using Tasocitinib in psoriasis patients. This study will see which medication is superior, Tasocitinib or Etanercept (current treatment already available). The study will last for 12 weeks with an opportunity to enter an extension study. This study is being conducted globally & there are 5 number of sites in the UK. Once patients have passed screening & have satisfied the study entry criteria, the patients will be selected by an automated system & given their selected treatment group. There are four potential treatment groups. Patients will be given only one treatment group at any one time during the 12 weeks. In each treatment group, patients are expected to take Tasocitinib 2/day orally & Etanercept 2/week via injection. Patients & site staff will not know which medication is real, so a non-drug is also given alongside the actual Tasocitinib OR Etanercept, depending on the treatment group the patient is assigned to. This non-drug will be made to look as if it's either Tasocitinib or Etanercept. Patients will not receive the actual Tasocitinib & actual Etanercept at any one time together. They will either receive the Tasocitinib OR Etanercept at any one time. When patients have completed the 12 week study they have the opportunity to enter the extension study where ALL patients will be given the Tasocitinib for up to 2 years.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/1812

• Date of REC Opinion

  13 Mar 2012

• REC opinion

  Further Information Favourable Opinion