Evaluation of the BRADA and ABILHAND Questionnaires

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00938444
• Lead Sponsor: University Hospital, Ghent

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 treated with tocilizumab will be asked to complete the BRADA and ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of treatment. All other assessments and questionnaires from daily clinical practice (such as the global assessment of disease activity by the patient, the Health Assessment Questionnaire (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will also be used to evaluate these questionnaires.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time.	after 24 weeks of treatment with tocilizumab

Trial Locations

Locations (19)

Jan Palfijn; 🇧🇪 Merksem, Antwerpen, Belgium

ASZ; 🇧🇪 Aalst, Belgium

Clinique St. Luc; 🇧🇪 Bouge, Belgium

CHU Brugmann; 🇧🇪 Brussel, Belgium

UCL St. Luc; 🇧🇪 Brussel, Belgium

UZA; 🇧🇪 Edegem, Belgium

AZ Sint-Lucas; 🇧🇪 Gent, Belgium

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Reuma Instituut; 🇧🇪 Hasselt, Belgium

AZ Groeninge; 🇧🇪 Kortrijk, Belgium

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