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Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Tokyo, , Japan
Contact
1-800-718-1021
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

NCT01932372
Pfizer
Active, not recruiting
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

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Descriptive Information
Brief TitleTofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
Official TitleXELJANZ (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 DescriptionAll 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 TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationAdult 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.
ConditionRheumatoid 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 StatusActive, not recruiting
Actual Enrollment
 (submitted: September 9, 2019)
10477
Original Estimated Enrollment
 (submitted: August 27, 2013)
6000
Estimated Study Completion DateDecember 15, 2020
Estimated Primary Completion DateDecember 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01932372
Other Study ID NumbersA3921194
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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