COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03281304
Recruitment Status : Active, not recruiting
First Posted : September 13, 2017
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : February 14, 2020
Estimated Study Completion Date : March 8, 2023

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT03281304

Show Show 90 study locations
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer Identifier: NCT03281304    
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 11, 2020
Last Verified: June 2020
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:

Layout table for additional information
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:
Layout table for MeSH terms
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action