CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9,968 enrolled
Drug / intervention
Tofacitinib (Xeljanz) +1 moredrug
Likely dose
Tofacitinib (Xeljanz) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01932372
NCT01932372N/ACompleted
CompareCT.gov

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

Pfizer·observational·Posted Aug 30, 2013·Updated Oct 26, 2024

In Brief

An observational study evaluating Tofacitinib (Xeljanz) and Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc for Rheumatoid Arthritis. Completed, enrolled 9,968 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 30, 2013
Enrollment StartJul 26, 2013
Primary CompletionAug 24, 2021
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 12.8 years ago

Interventions

Tofacitinib (Xeljanz)drug

5 mg Tablet BID

Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etcdrug

Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly