Defining Remission With Etanercept in AS in Real Life Clinical Practice
NCT ID: NCT02202850
Last Updated: 2018-11-30
Study Results
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View full resultsBasic Information
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COMPLETED
84 participants
OBSERVATIONAL
2014-08-12
2017-04-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Etanercept First
Adults patients with AS receiving Etanercept as first biologic, according to prevailing reimbursement criteria in Belgium
etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
Etanercept second
Adults patients with AS receiving Etanercept as second biologic, according to prevailing reimbursement criteria in Belgium
etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
Interventions
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etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
etanercept
etanercept 1 x 50 mg/week or 2 x 25mg/week
Eligibility Criteria
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Inclusion Criteria
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. 18 years of age or older at time of consent
4. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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CHU Brugmann - Site Horta
Brussels, Bruxelles-capitale, Région de, Belgium
ASZ Aalst
Aalst, , Belgium
Algemeen Stedelijk Ziekenhuis
Aalst, , Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, , Belgium
Private Practice
Braine-l'Alleud, , Belgium
CHIREC
Brussels, , Belgium
CHU St-Pierre
Brussels, , Belgium
Private Practice
Champion, , Belgium
AZ Sint Blasius
Dendermonde, , Belgium
Private Practice
Flemalles Haute, , Belgium
Biomedical Research Institute/ Department of Rheumatology
Genk, , Belgium
Private Practice Rheumatology
Genk, , Belgium
ReumaClinic
Genk, , Belgium
Reumatologie Associatie
Genk, , Belgium
Private Practice
Genk, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Grand Hopital de Charleroi
Gilly, , Belgium
Private Practice
Grand-Manil, , Belgium
AZ Groeninge Campus Sint Maarten
Kortrijk, , Belgium
CHU de Liège
Liège, , Belgium
Private Practice of Dr. Geert Ghyselen
Lokeren, , Belgium
Louisastraat 18
Mechelen, , Belgium
Hôpital Sainte Thérèse/ Department of Rheumatology
Montignies-sur-Sambre, , Belgium
Rheumatology
Ostend, , Belgium
Office of Maenaut Kristien
Schoten, , Belgium
Rheumatology
Sijsele-Damme, , Belgium
Sint-Andries Ziekenhuis
Tielt, , Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, , Belgium
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1801379
Identifier Type: OTHER
Identifier Source: secondary_id
REACH-AS
Identifier Type: OTHER
Identifier Source: secondary_id
B1801379
Identifier Type: -
Identifier Source: org_study_id
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