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

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NCT01877239

Last updated on April 10, 2018
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FOR MORE INFORMATION
Study Location
Ordination Dr. Thomas Muller
Graz, , 8010 Austria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT01877239
Pfizer
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

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Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria
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
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.
Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A
Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Rheumatoid Arthritis
Other: non-intervention
observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC
Full Analysis Set
Full Analysis Set (FAS): The FAS contains any patient that has given written informed consent.
Intervention: Other: non-intervention
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
June 2016
January 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01877239
B1801357
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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