Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

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NCT01932372

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Study Location
Tokyo, , , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- All patients receiving Tofacitinib (Xeljanz)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Not Applicable

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Advanced Information
Descriptive Information
Brief Title Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
Official Title XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)
Brief Summary

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.

1) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2? Long-term safety (particularly, malignant tumors and serious infections) and efficacy

Occurrences of malignant tumors and serious infections will be compared with a control group.

Detailed Description All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to over 8 mg Methotrexate for 3 months treatment.
Condition Rheumatoid Arthritis
Intervention
  • Drug: Tofacitinib (Xeljanz)
    5 mg Tablet BID
  • Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
    Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly
Study Groups/Cohorts
  • Tofacitinib (Xeljanz)
    Tablets 5 mg BID
    Intervention: Drug: Tofacitinib (Xeljanz)
  • Standard of Care
    Standard of Care for Rheumatoid Arthritis
    Intervention: Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
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 Active, not recruiting
Actual Enrollment
 (submitted: September 9, 2019)		10477
Original Estimated Enrollment
 (submitted: August 27, 2013)		6000
Estimated Study Completion Date December 15, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients receiving Tofacitinib (Xeljanz)

Exclusion Criteria:

Not Applicable

Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01932372
Other Study ID Numbers A3921194
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2019