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Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Last updated on May 10, 2018

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Study Location
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.
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- All patients receiving Tofacitinib (Xeljanz)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT01932372
Pfizer
Active, not recruiting
Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

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Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
Tofacitinib Special Investigation Of Xeljanz Tablets 5mg. (Regulatory Post Marketing Commitment Plan)

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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Rheumatoid Arthritis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
6000
January 26, 2021
January 26, 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients receiving Tofacitinib (Xeljanz)

Exclusion Criteria:

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01932372
A3921194
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

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[email protected]



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