Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932372
• Other study ID #: A3921194
• Status: Completed
• Start date: July 26, 2013
• Est. completion date: August 24, 2021

Study information

• Verified date: September 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9968
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients receiving Tofacitinib (Xeljanz) Exclusion Criteria: Not Applicable

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tofacitinib (Xeljanz)
5 mg Tablet BID
• Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score Based on 28-joints Count (DAS28)	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 =3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.	24 months
Primary	Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	36 months

External Links

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