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

NCT ID: NCT01646385

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6393 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2012-08-31

Brief 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.

Detailed Description

patients recruited sequentially as seen in clinical practice

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

etanercept

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

etanercept

Intervention Type: DRUG

use as per routine clinical practice

nbDMARD

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

non-biologic anti-rheumatic drugs

Intervention Type: DRUG

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

Interventions

etanercept

use as per routine clinical practice

Intervention Type: DRUG

non-biologic anti-rheumatic drugs

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801348&StudyName=Study%20to%20assess%20the%20safety%20and%20efficacy%20of%20etanercept%20in%20patients%20treated%20over%20the%20long-term%20in%20real-world%20clinical%20practice%2C%20using%20

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Other Identifiers

B1801348

Identifier Type: -

Identifier Source: org_study_id