Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: non-biologic anti-rheumatic drugs; Drug: etanercept

Study type: Observational

Funder types: Industry

Identifiers

NCT01646385

B1801348

Details and patient eligibility

About

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.

Full description

patients recruited sequentially as seen in clinical practice

Enrollment: 6,393 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult
• rheumatoid arthritis
• group 1: initiating etanercept as first biologic therapy
• group 2: DAS28<4.2, biologic naive and treated with non-biologic DMARDs

Exclusion criteria

• diagnosis of other inflammatory arthritis

Trial design

6,393 participants in 2 patient groups

etanercept

Description:

adult rheumatoid arthritis patients initiating therapy with etanercept as their first biologic therapy

Treatment:

Drug: etanercept

nbDMARD

Description:

biologic-naive adult rheumatoid arthritis patients with DAS28 \>4.2 treated with non-biologic anti-rheumatic drugs(s).

Treatment:

Drug: non-biologic anti-rheumatic drugs