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



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:November 16, 2017
End Date:November 22, 2022
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 3B/4,MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION

This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission
designed to evaluate flexible dosing of CP-690,550.


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
We found this trial at
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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610 3rd St # 206
Macon, Georgia 31201
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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Bristol, Connecticut 06010
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Bristol, Connecticut 06010
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Chesterfield, Michigan 48098
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Chevy Chase, Maryland 20815
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Egg Harbor Township, New Jersey 08234
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Houston, Texas 77030
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Houston, Texas 77030
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17700 23 Mile Road
Macomb, Michigan 48044
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6001 Airport Boulevard
Mobile, Alabama 36608
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Mobile, Alabama 36606
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New York, New York 10019
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New York, New York 10028
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New York, New York 10032
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Plainville, Connecticut 06062
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Salt Lake City, Utah 84102
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Salt Lake City, Utah 84102
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Salt Lake City, Utah 84107
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San Diego, California 92103
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4033 3rd Ave # 106
San Diego, California 92103
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Troy, Michigan 48098
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Troy, Michigan 48098
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1720 South Beckham Avenue
Tyler, Texas 75701
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Zephyrhills, Florida 33542
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