Last updated on March 2020

A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.
  • In stable remission on CP-690,550 10 mg BID
  • Agree to use highly effective contraception
  • Negative pregnancy test
  • Comply with visits, treatments, lab tests, diary and other study procedures
  • Signed and dated informed consent document.

Exclusion Criteria:

  • Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.
  • Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease
  • Likely to require surgery for ulcerative colitis during study
  • Expected to receive any prohibited medication
  • Expected to receive live or attenuated virus vaccination during study
  • Women who are pregnant or breastfeeding or planning to become pregnant during the study
  • Evidence of colonic malignancy or any dysplasia
  • Acute or chronic medical or psychiatric condition that may increase risk of participation
  • Investigator site staff member
  • Subjects likely to be uncooperative or unable to comply with study procedures
  • Participation in other studies involving investigational drugs during study
  • Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:
  • has heart failure;
  • has inherited coagulation disorders;
  • has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
  • is taking combined hormonal contraceptives or hormone replacement therapy;
  • has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
  • is undergoing major surgery

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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