CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6,393 enrolled
Drug / intervention
etanercept +1 moredrug
Likely dose
Not stated in 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/NCT01646385
NCT01646385N/ACompleted

Long-term Safety and Efficacy of Etanercept in a UK Observational Cohort Study - a Retrospective Database Analysis of British Society of Rheumatology Biologics Registry (BSRBR) Data

Pfizer·observational·Posted Jul 20, 2012·Updated Aug 5, 2014

In Brief

An observational study evaluating etanercept and non-biologic anti-rheumatic drugs for Rheumatoid Arthritis. Completed, enrolled 6,393 participants.

Detailed Summary

This study will assess the rates of serious adverse events and death in adult rheumatoid arthritis patients treated with etanercept over the long-term in real-life clinical practice. It will also assess whether there is any difference in the rate of serious adverse events in patients trated with etanercept in comparision to patients treated with conventional disease-modifying anti-rheumatic drugs (DMARDs). The study will in addition quantify the efficacy of etanercept in this population by assessing the rates of important clinical outcomes such as changes in disease activity and disability/functioning.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2012
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.0 years ago

Interventions

etanerceptdrug

use as per routine clinical practice

non-biologic anti-rheumatic drugsdrug

use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)