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Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

NCT02092467 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4372

Last updated 2021-08-17

Study results available
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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.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

tofacitinib

Oral tablet, 5 mg BID

DRUG

tofacitinib

Oral tablet, 10 mg BID

BIOLOGICAL

adalimumab

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

BIOLOGICAL

etanercept

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-14
Primary Completion
2020-07-22
Completion
2020-07-22

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092467 on ClinicalTrials.gov