Please select the eligibility criteria that correspond to the clinical trial below.
Title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Brief Summary: This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.


Options:
A: Inclusion Criteria:

* Patients must be at least 18 years of age at screening
* Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months prior to entry into the study.
* Male and female patients with active currently moderate to severe ulcerative colitis defined by Mayo score of ≥6
* Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of baseline.

Exclusion Criteria:

* Diagnosis of Crohn's disease or diagnosis of indeterminate colitis
* Treatment naive subjects who have not had previous exposure to treatment for ulcerative colitis
* Patients that are currently receiving immunosuppressants, anti-TNFα therapy or interferon
B: Inclusion Criteria:

* Subject must be at least 18 years of age.
* Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
* Subjects with moderately to severely active UC based on Mayo score criteria.
* Subjects must have failed or be intolerant of at least one of the following treatments for UC:

  * Corticosteroids (oral or intravenous).
  * Azathioprine or 6 mercaptopurine (6 MP).
  * Anti TNF-alpha therapy.

Exclusion Criteria:

* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects with disease limited to distal 15 cm.
* Subjects without previous treatment for UC (ie, treatment naïve).
* Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
C: Inclusion Criteria:

* Subjects who completed induction studies A3921094 or A3921095 and were classified as not meeting clinical response criteria; OR
* Subjects who completed maintenance study A3921096 or who discontinued treatment early in Study A3921096 due to treatment failure.

Exclusion Criteria:

* Subjects who had a major protocol violation in Study A3921094, A3921095 or A3921096.
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects who have had surgery for ulcerative colitis or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study period.
D: 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

Answer: C