Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice
NCT02202837
ABOUT THIS STUDY
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1. Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.
1. First cohort: Etanercept is the first biological product prescribed.
2. Second cohort: Etanercept is the second biological product prescribed.
2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
3. Eighteen (18) years of age or older at time of consent.
1. History of or current psychiatric illness that would interfere with the subject's
ability to comply with protocol requirements or to give informed consent.
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Descriptive Information | ||||
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Brief Title | Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice | |||
Official Title | Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered)) | |||
Brief Summary | Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept | |||
Detailed Description | The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies. This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups. In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period. | |||
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 | Adult patients presenting with moderate-to-severe RA in daily clinical practice | |||
Condition | Rheumatoid Arthritis | |||
Intervention | Drug: etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week | |||
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 | 157 | |||
Original Estimated Enrollment | 140 | |||
Actual Study Completion Date | April 24, 2017 | |||
Actual Primary Completion Date | April 24, 2017 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: 1. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent. | |||
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 | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT02202837 | |||
Other Study ID Numbers | B1801378 B1801378 ( Other Identifier: Alias Study Number ) REACH-RA ( Other Identifier: Alias Study Number ) | |||
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 |
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PRS Account | Pfizer | |||
Verification Date | April 2018 |