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

Last updated on June 12, 2019

FOR MORE INFORMATION
Study Location
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT03281304
Pfizer
Recruiting
A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now