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

NCT03281304

Last updated date
Study Location
North Shore Hospital (Waitemata District Health Board)
Auckland, , 0622, New Zealand
Contact
1-800-718-1021

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]

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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 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.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 3, 2020)
118
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
130
Estimated Study Completion Date  ICMJE March 8, 2023
Actual Primary Completion Date February 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03281304
Other Study ID Numbers  ICMJE A3921288
RIVETING STUDY ( Other Identifier: Alias Study Number )
2017-002274-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP