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

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NCT03281304

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Surgicare of Mobile
Mobile, Alabama, 36606 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- Currently enrolled in Study A3921139 on CP-690,550 10 mg BID

- 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.
Show details

- Currently enrolled in Study A3921139 on CP-690,550 5 mg BID

- 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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[email protected]

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A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: CP-690,500 5 mg
    CP-690,550 5 mg tablet BID
  • Drug: CP-690,550 10 mg
    CP-690,550 10 mg tablet BID
  • Experimental: CP-690,550 5 mg
    CP-690,550 5 mg tablet by mouth twice a day (BID)
    Intervention: Drug: CP-690,500 5 mg
  • Experimental: CP-690,550 10 mg
    CP-690,550 10 mg BID
    Intervention: Drug: CP-690,550 10 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 16, 2021
November 9, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Currently enrolled in Study A3921139 on CP-690,550 10 mg BID
  • 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:

  • Currently enrolled in Study A3921139 on CP-690,550 5 mg BID
  • 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
Sexes Eligible for Study: All
Child, Adult, Senior
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan,   United States
 
 
NCT03281304
A3921288
RIVETING STUDY ( Other Identifier: Alias Study Number )
2017-002274-39 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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