Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: non-intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01877239

B1801357

Details and patient eligibility

About

This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.

Full description

Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
2. The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol.
3. The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data.
4. The patient has moderately active RA, defined as a disease activity of CDAI >10 and ≤22 and/or DAS28 (CRP)>3.2 and ≤ 5.1

Exclusion criteria

1. Any contraindication according to the Austrian SmPC, which includes:

   A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.

2. Patient has previously participated in this study.

Trial design

111 participants in 1 patient group

Full Analysis Set

Description:

Full Analysis Set (FAS): The FAS contains any patient that has given written informed consent.

Treatment:

Other: non-intervention