CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 4,372 enrolled
Drug / intervention
tofacitinib +3 moredrug
Likely dose
tofacitinib 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/NCT02092467
NCT02092467Phase 4Completed
CompareCT.gov

PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS

Pfizer·interventional·Posted Mar 20, 2014·Updated Aug 17, 2021

In Brief

A Phase 4 clinical trial evaluating tofacitinib, adalimumab, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 4,372 participants across 345 sites in 30 countries.

Detailed Summary

This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Finland, Hong Kong, Israel, Jordan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Puerto Rico, Russia, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 20, 2014
Enrollment StartMar 14, 2014
Primary CompletionJul 22, 2020
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 12.3 years ago

Interventions

tofacitinibdrug

Oral tablet, 5 mg BID

tofacitinibdrug

Oral tablet, 10 mg BID

adalimumabbiological

Pre-filled syringe, 40 mg subcutaneous injection, every other week

etanerceptbiological

Pre-filled syringe, 50 mg subcutaneous injection, every week