Clinical trial NCT01877239: Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria
Official title: A Multicenter Non-interventional Study To Observe The Safety And Efficacy Of Etanercept (Enbrel (Registered)) In Patients With Moderately Active Rheumatoid Arthritis In Every Day Clinical Practice In Austria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderately active RA that are treated with Etanercept will be studied. All patients enrolled should meet the usual prescribing criteria for Etanercept as per the Austrian SmPC and should be entered into the study at the investigator's discretion.

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 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.

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 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.

Primary outcomes:
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) Status of Disease Activity at Week 12 and Week 52
timeFrame: Week 12 and Week 52
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Scores at Week 12, Week 24 and Week 52
timeFrame: Baseline, Week 12, Week 24, Week 52
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Ordination Dr. Thomas Muller
city: Graz
country: Austria
facility: Barmherzige Brüder Graz Eggenberg
city: Klagenfurt
country: Austria
facility: Ordination Dr. Horst Just
city: Linz
country: Austria
facility: Ordination Dr. Richard Janetschko
city: Linz
country: Austria
facility: Ordination Dr. Wilhelm Kaiser
city: Linz
country: Austria
facility: Dr. Eichbauer-Sturm
city: Vienna
country: Austria
facility: Rheumazentrum Oberlaa
city: Wiener Neudorf
country: Austria
facility: Ordination Dr. Thomas Schwingenschlogl
city: Wien
country: Austria
facility: Ordination Dr. Peter Peichl
city: Wien
country: Austria
facility: Ordination Dr. Maya Thun
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: