Status:
COMPLETED
Evaluation of the BRADA and ABILHAND Questionnaires
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid arthritis (RA) patients that will be treated with an effective therapy. Patients with moderate to severe RA tr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- patients with moderate to severe RA.
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00938444
Start Date
June 1 2009
End Date
December 1 2010
Last Update
July 14 2011
Active Locations (19)
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1
Jan Palfijn
Merksem, Antwerpen, Belgium, 2170
2
ASZ
Aalst, Belgium, 9300
3
Clinique St. Luc
Bouge, Belgium, 5004
4
CHU Brugmann
Brussels, Belgium, 1020