B0151003 Crohn’s Disease ANDANTE Study

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-04236921 In subjects With Crohn’s Disease Who Are Anti-TNF Inadequate responders (Andante)

• IRAS ID

  78790

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2010-023034-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Crohn??s disease (CD) is a chronic, inflammatory disease of the gastrointestinal (GI) tract. Although the exact cause of CD remains unclear, over production of inflammatory agents, such as cytokines, may be potential targets for treatment. Improved treatments are needed for CD for the majority of patients who have active disease despite currently available therapies.This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody (study drug, PF-04236921). Antibodies are proteins that help the body??s immune response. This study is being conducted to investigate the effect of blocking IL-6 (Interleukin 6), an inflammatory cytokine involved in the symptoms of Crohn??s disease, with the study drug, PF-04236921 in patients who have already failed to improve with an anti-TNF antibody. Subjects will be randomized to a treatment and the active dose or placebo will be delivered with an injection administered under the skin twice, 4 weeks apart. This study is recruiting men and women between the ages of 18-75 who have a lot of symptoms from Crohn's Disease despite treatment. Key inclusion criteria include subjects that have failed or are intolerant to anti TNFs (such as Remicade©, Humira©, or Cimzia©), subjects who have an hsCRP (high-sensitivity C-reactive protein) greater or equal to 5 mg/L and ulcerations demonstrated by a colonoscopy performed. This study is being conducted globally in 17 countries across approximately 100 clinical sites. Approximately 240 subjects will be enrolled in the study for a period of 4 to 11 months. At the end of the 12 week treatment period, subjects will either stay in the study for a 28 week follow-up period or may be eligible to join another study and receive additional treatment with study drug, PF-04236921.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  11/NE/0212

• Date of REC Opinion

  15 Sep 2011

• REC opinion

  Further Information Favourable Opinion