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

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ClinicalTrials.gov Identifier: NCT03281304
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: CP-690,500 5 mg Drug: CP-690,550 10 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 22, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CP-690,550 5 mg
CP-690,550 5 mg tablet by mouth twice a day (BID)
Drug: CP-690,500 5 mg
CP-690,550 5 mg tablet BID

Experimental: CP-690,550 10 mg
CP-690,550 10 mg BID
Drug: CP-690,550 10 mg
CP-690,550 10 mg tablet BID




Primary Outcome Measures :
  1. Remisson based on Mayo score [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Time to loss of remission based on modified Mayo score [ Time Frame: From first visit up to Month 42 ]
  2. Remission based on modified Mayo score [ Time Frame: Month 42 ]
  3. Remission based on modified partial Mayo score [ Time Frame: Month 42 ]
  4. Remission based on total Mayo score [ Time Frame: Month 42 ]
  5. Remission based on partial Mayo score [ Time Frame: Month 42 ]
  6. Change from baseline in modified Mayo score [ Time Frame: Baseline and Month 42 ]
  7. Change from baseline in modified partial Mayo score [ Time Frame: Baseline and Month 42 ]
  8. Change from baseline in total Mayo score [ Time Frame: Baseline and Month 42 ]
  9. Change from baseline in partial Mayo score [ Time Frame: Baseline and Month 42 ]
  10. Mucosal healing [ Time Frame: Month 42 ]
  11. Clinical response based on Mayo score [ Time Frame: Month 42 ]
  12. Change from baseline in fecal calprotectin [ Time Frame: Baseline and Month 42 ]
  13. Change from baseline in hs-CRP [ Time Frame: Baseline and Month 42 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281304


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 94 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03281304     History of Changes
Other Study ID Numbers: A3921288
RIVETING STUDY ( Other Identifier: Alias Study Number )
2017-002274-39 ( EudraCT Number )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
ulcerative colitis
inflammatory bowel disease

Additional relevant MeSH terms:
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Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action