Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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);
