Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
NCT01932372
Last updated date
ABOUT THIS STUDY
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.
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
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
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 |
| ||||
| Study Groups/Cohorts |
| ||||
| 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 | 9968 | ||||
| Original Estimated Enrollment | 6000 | ||||
| Estimated Study Completion Date | March 16, 2021 | ||||
| Estimated Primary Completion Date | March 16, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Not Applicable | ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | October 2020 | ||||