A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice
NCT ID: NCT03291457
Last Updated: 2020-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2017-03-30
2019-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Glucocorticoids + Tocilizumab
Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
Tocilizumab
For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.
Glucocorticoid Agent
Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.
Interventions
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Tocilizumab
For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.
Glucocorticoid Agent
Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
* Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
* Treated with glucocorticoids for RA when starting tocilizumab treatment
Exclusion Criteria
* Continuous or regular treatment with oral corticosteroids for any indication other than RA
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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ASZ Aalst
Aalst, , Belgium
Onze Lieve Vrouwziekenhuis Aalst
Aalst, , Belgium
Dr. Huppertz - Marx pgmbh
Amel, , Belgium
Private Practice Els Van Essche
Bonheiden, , Belgium
AZ Sint Jan
Bruges, , Belgium
CHU St Pierre (César de Paepe)
Brussels, , Belgium
Hospital Erasme
Brussels, , Belgium
Rhumarc sciv sprl
Céroux-Mousty, , Belgium
UZ Antwerpen
Edegem, , Belgium
Rhumaconsult sciv sprl; Private Practice
Forchies-la-Marche, , Belgium
Reumacentrum Genk
Genk, , Belgium
Reumaclinic
Genk, , Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, , Belgium
GHdC Site Saint-Joseph
Gilly (Charleroi), , Belgium
Heilig Hartziekenhuis vzw
Lier, , Belgium
CHC MontLégia
Liège, , Belgium
CHU de Liège; Rhumatologie
Liège, , Belgium
Private Practice; Reumatologie
Mechelen, , Belgium
AZ Damiaan
Ostend, , Belgium
AZ Alma vzw (Sijsele)
Sijsele, , Belgium
AZ Turnhout Sint Jozef
Turnhout, , Belgium
AZ Sint Jozef Malle
Westmalle, , Belgium
Countries
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Other Identifiers
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ML39114
Identifier Type: -
Identifier Source: org_study_id
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