Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

Pfizer

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate (MTX)

Biological: etanercept

Study type

Observational

Funder types

Industry

Identifiers

NCT01557322

B1801345

Details and patient eligibility

About

To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.
To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).

Full description

Retrospective database analysis

Enrollment

1,754 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:

Patients aged 18 years and over at the time of diagnosis;
Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
Patients who have given informed consent for long term follow-up and access to all medical records;
Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA.

The Control Group:

Patients aged 18 years and over a the time of diagnosis;
Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent;

Exclusion criteria

Per BSRBR registry since data is retropsectively being analyzed