Prospective Evaluation of the Radiographic Efficacy of Enbrel
NCT01623752
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Definitive diagnosis of RA or PsA.
- Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC).
- Inclusion of subjects pretreated with other biologics other than Etanercept is possible
- One plain radiograph of hands and feet (Anteroposterior) within 3 month prior to initiation of treatment with Etanercept and one planned consecutive radiograph of hand and feet taken over 12 to 18 months according to German recommendations for patients treated with biologics.
- Receipt of any investigational drug within 3 months of study inclusion.
- Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:
- Hypersensitivity to the active substance (etanercept) or to any of the excipients.
- Sepsis or risk of sepsis.
- Active infections, including chronic or localised infections.
- Subjects who have received any previous treatment with etanercept
- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.
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Descriptive Information | |||||
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Brief Title | Prospective Evaluation of the Radiographic Efficacy of Enbrel | ||||
Official Title | A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS. | ||||
Brief Summary | It is known from the COMET-trial that patients who start Enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. It is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine rheumatologic care and the local recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX). Therefore, no robust x-ray data are available to show/demonstrate
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Detailed Description | Non-interventional study: subjects to be selected according to the usual clinical practice of their physician | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Rheumatoid Arthritis or Psoriasis Arthritis | ||||
Condition |
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Intervention | Drug: Etanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. Other Name: Enbrel | ||||
Study Groups/Cohorts |
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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 | 1821 | ||||
Original Estimated Enrollment | 1500 | ||||
Actual Study Completion Date | March 2018 | ||||
Actual Primary Completion Date | March 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Exclusion Criteria:
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Sex/Gender |
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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 | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT01623752 | ||||
Other Study ID Numbers | B1801317 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | July 2019 |