008: Oral CP-690,550 as Maintenance Therapy for Ulcerative Colitis

• Research type

  Research Study

• Full title

  A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS A MAINTENANCE THERAPY IN SUBJECTS WITH ULCERATIVE COLITIS

• IRAS ID

  92095

• Contact name

  Stuart Bloom

• Sponsor organisation

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

• Eudract number

  2011-004580-79

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Ulcerative colitis (UC) is an inflammatory bowel disease characterised by chronic, relapsing, inflammatory disease of the colon. Although the precise cause is unknown, UC is thought to arise as a result of the body being unable to appropriately downregulate its immune response to certain pathogens (bad bacteria) that live naturally in our gut. This defective immune response results in periods of enhanced inflammation and tissue damage with symptoms including diarrhea, rectal bleeding and abdominal pain. Patients will typically experience intermittent flare-ups of the disease, followed by periods of disease remission. Current therapies include anti-inflammatory drugs, steroids and immunosuppressants; however, a significant proportion of UC patients still require colectomy (partial or total removal of the large bowel through surgery) or restorative proctocolectomy (surgical removal of the rectum and all or part of the colon with restoration of continuity). These procedures are often considered as a cure for UC, however the resultant effects to the patients quality life mean alternative pharmacological alternatives are desirable. The primary treatment goal of new therapies is to induce remission and then maintain this state. CP-690,550 is a chemical inhibitor that can act to suppress the immune system by blocking the production of molecules that stimulate the immune response. This clinical trial aims to assess the effectiveness of CP-690,550 in inducing remission in patients suffering moderate to severe active ulcerative colitis. This study follows on from the induction study (A3921094) where at the end of the induction study patients who complete the treatment period and achieve a positive clinical response at Week 8 are eligible to enter this maintenance study. Approximately 654 patients will be eligible for enrollment (from two induction studies each with 545 participants). Throughout the study these patients will undergo: - Physical examinations, vital signs, and ECG - Blood samples for laboratory analysis - Endoscopic procedures - Ulcerative colitis assessments -Health outcome assessment questionnaires.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/0081

• Date of REC Opinion

  30 Apr 2012

• REC opinion

  Favourable Opinion