A3921288 Phase 3B/4 Study of Tofacitinib in Subjects with UC

• Research type

  Research Study

• Full title

  A PHASE 3B/4, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

• IRAS ID

  235126

• Contact name

  Thomas Creed

• Contact email

  tom.creed@uhbristol.nhs.uk

• Sponsor organisation

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

• Eudract number

  2017-002274-39

• Clinicaltrials.gov Identifier

  35196, Registration of Study with NIHR

• Duration of Study in the UK

  2 years, months, days

• Research summary

  Summary of Research
  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 diarrhoea, rectal bleeding and abdominal pain. Patients will typically experience intermittent flareups of the disease, followed by periods of disease remission.\n\nCurrent therapies include anti-inflammatory drugs, steroids and immunosuppressants (an agent that can suppress or prevent the immune response); 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 of life mean alternative pharmacological alternatives are desirable.\n\nThe primary treatment goal of new therapies is to induce remission and then maintain this state. The study drug used in this study, tofacitinib, also known as CP690,550 is a chemical inhibitor that can act to suppress the immune system by blocking the production of molecules that stimulate the immune response. \n\nThis is a Phase 3B/4 study and patients who have UC, who are in stable remission and participated in the A3921139 study are suitable to enter this study. The purpose of this research study is to learn more about the effects of CP-690,550. There will be approximately 130 people taking part in this research study and it will be conducted in approximately 20 countries across approximately 85 different sites. The study will have 18 months of treatment duration. Throughout these 18 months, these patients will undergo physical examinations, vital signs, blood samples for laboratory analysis, flexible Sigmoidoscopy/colonoscopy and Ulcerative Colitis Assessments.\n

  Summary of Results
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVtiUO83io7x4WP0JR0wpUEUa9LVIjzct2HBfE00rQsxr1vfRXXUItp5FqrWVAhOp-2FB1P1eAc-2FS4eOkAui8NSzLlTLP2ujllqa4zxKecu6m8W018_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLpEzPRh6YOBYUjmZ2-2BY9vDct6rhuS6-2Bo2mvk8-2Fg9JCbTgbkvjh7WiBL4OKfxvLUcAAtFa-2B3yb1o1zBUUE2t42ZO0T2VyHOoJLFMsRERmz5IcAFzu-2BCry2sAeMi99fqmD-2FWIa2Ut8S7AIZHd7qWnlSUpY7xuHZgcwPleIsNnsiRtA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C68bd06a0861e4aa3ad6208db18a3ba62%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638130863714288811%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=7VDNrJ0JT%2Fanw172tLqz%2Fc0%2BIEGiJqyGl53RfkNNs4Y%3D&reserved=0
  Search for Protocol ID A3921288

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  18/SW/0050

• Date of REC Opinion

  12 Apr 2018

• REC opinion

  Further Information Favourable Opinion