Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria
NCT01877239
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Adult Trials: 18+ Years
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
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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| 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 | 111 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | April 2018 | |||