Evaluation of the BRADA and ABILHAND Questionnaires

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00938444
First received: July 10, 2009
Last updated: July 13, 2011
Last verified: July 2011

July 10, 2009
July 13, 2011
June 2009
December 2010   (final data collection date for primary outcome measure)
Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time. [ Time Frame: after 24 weeks of treatment with tocilizumab ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00938444 on ClinicalTrials.gov Archive Site
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Evaluation of the BRADA and ABILHAND Questionnaires
Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with moderate to severe RA.

Rheumatoid Arthritis
Not Provided
Patients with moderate to severe RA
Patients with moderate to severe RA treated with Tocilizumab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00938444
2009/190, ML22613
No
Filip De Keyser, MD PhD, University Hospital Ghent
University Hospital, Ghent
Roche Pharma AG
Principal Investigator: Filip De Keyser, MD, PhD University Hospital, Ghent
University Hospital, Ghent
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP