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

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Study Location
Ordination Dr. Thomas Muller
Graz, , 8010, Austria
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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.

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Advanced Information
Descriptive Information
Brief Title 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
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
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Rheumatoid Arthritis
Intervention Other: non-intervention
observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC
Study Groups/Cohorts Full Analysis Set
Full Analysis Set (FAS): The FAS contains any patient that has given written informed consent.
Intervention: Other: non-intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2018)		111
Original Estimated Enrollment
 (submitted: June 12, 2013)		120
Actual Study Completion Date June 14, 2016
Actual Primary Completion Date January 7, 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria
Removed Location Countries  
 
Administrative Information
NCT Number NCT01877239
Other Study ID Numbers B1801357
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2018