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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-10

Study Completion Date

2016-06-14

Brief Summary

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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.

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Detailed Description

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

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Full Analysis Set

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

non-intervention

Intervention Type OTHER

observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC

Interventions

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non-intervention

observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No