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Xeljanz Special Investigation for Long-term Use in UC Patients

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.
 
ClinicalTrials.gov Identifier: NCT03643211
Recruitment Status : Active, not recruiting
First Posted : August 22, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Condition or disease
Ulcerative Colitis

Detailed Description:
This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: XELJANZ® TABLETS 5 MG SPECIAL INVESTIGATION (INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS)
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : January 4, 2022
Estimated Study Completion Date : January 4, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xejanz cannot be ruled out) [ Time Frame: 60 weeks ]
    Primary outcome measure is the incident condition of major adverse drug reactions (adverse events for which the causal relationship with Xejanz cannot be ruled out) in 60 weeks observation period.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients
Criteria

Inclusion Criteria:

  • Patients with ulcerative colitis treated with XELJANZ
  • Patients naive to XELJANZ in the treatment of ulcerative colitis

Exclusion Criteria:

- None


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): NCT03643211


Locations
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Japan
Pfizer Local Country Office
Tokyo, Japan
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: NCT03643211     History of Changes
Other Study ID Numbers: A3921248
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Xljanz
Ulcerative colitis
UC
Long-term
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
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