Status:
COMPLETED
Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 wee...
Detailed Description
Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A
Eligibility Criteria
Inclusion
- The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
- 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.
- 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.
- 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
- Any contraindication according to the Austrian SmPC, which includes:
- A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
- Patient has previously participated in this study.
Key Trial Info
Start Date :
December 10 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 14 2016
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT01877239
Start Date
December 10 2012
End Date
June 14 2016
Last Update
December 3 2018
Active Locations (10)
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1
Ordination Dr. Thomas Muller
Graz, Austria, 8010
2
Barmherzige Brüder Graz Eggenberg
Graz, Austria, 8020
3
Ordination Dr. Horst Just
Klagenfurt, Austria, 9020
4
Ordination Dr. Richard Janetschko
Linz, Austria, 4020