- 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.
- 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