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
80 participants
OBSERVATIONAL
2009-06-30
2010-12-31
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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Patients with moderate to severe RA
Patients with moderate to severe RA treated with Tocilizumab
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Inadequate response on earlier optimal use of a minimum of two DMARDs (disease modifying anti-rheumatic drugs such as goldsalts, salazopyrine, leflunomide, methotrexate (MTX)) as far as one of the two used DMARDs is MTX that at the exception of a documented intolerance despite the association with folic acid, should have been administered IM or oral during a minimum of 3 months and at a minimal dose of 15mg/week.
* DAS 28 score ≥ 5.1
* For whom a drug that is registered for the treatment of moderate to severe RA is commercially available but does not constitute a satisfactory treatment for this patient.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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University Hospital Ghent
Principal Investigators
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Filip De Keyser, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Jan Palfijn
Merksem, Antwerpen, Belgium
ASZ
Aalst, , Belgium
Clinique St. Luc
Bouge, , Belgium
CHU Brugmann
Brussels, , Belgium
UCL St. Luc
Brussels, , Belgium
UZA
Edegem, , Belgium
AZ Sint-Lucas
Ghent, , Belgium
University Hospital Ghent
Ghent, , Belgium
Reuma Instituut
Hasselt, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
CH Notre Dame - R Fabiola
Montignies-sur-Sambre, , Belgium
Clinique St. Pierre
Ottignies, , Belgium
Clinique St. Vincent
Rocourt, , Belgium
Heilig Hartziekenhuis
Roeselare, , Belgium
AZ Alma
Sijsele, , Belgium
Hôpital de Jolimont
Soignies, , Belgium
UCL Mont-Godinne
Yvoir, , Belgium
Countries
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References
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Janssens X, Decuman S, De Keyser F; Brada I study group. Construction and psychometric properties of the Belgian Rheumatoid Arthritis Disability Assessment (BRADA) questionnaire: a new tool for the evaluation of activity limitations in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2013 Jul-Aug;31(4):596-605. Epub 2013 Jul 30.
Related Links
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website of the University Hospital Ghent
Other Identifiers
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ML22613
Identifier Type: -
Identifier Source: secondary_id
2009/190
Identifier Type: -
Identifier Source: org_study_id
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