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
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with moderate to severe RA
Patients with moderate to severe RA treated with Tocilizumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with moderate to severe RA.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938444

Locations
Belgium
Jan Palfijn
Merksem, Antwerpen, Belgium, 2170
ASZ
Aalst, Belgium, 9300
Clinique St. Luc
Bouge, Belgium, 5004
UCL St. Luc
Brussel, Belgium, 1200
CHU Brugmann
Brussel, Belgium, 1020
UZA
Edegem, Belgium, 2650
AZ Sint-Lucas
Gent, Belgium, 9000
University Hospital Ghent
Ghent, Belgium, 9000
Reuma Instituut
Hasselt, Belgium, 3500
AZ Groeninge
Kortrijk, Belgium, 8500
UZ Gasthuisberg
Leuven, Belgium, 3000
CHU de Liège
Luik, Belgium, 4000
CH Notre Dame - R Fabiola
Montignies-sur-Sambre, Belgium, 6061
Clinique St. Pierre
Ottignies, Belgium, 1340
Clinique St. Vincent
Rocourt, Belgium, 4000
Heilig Hartziekenhuis
Roeselare, Belgium, 8800
AZ Alma
Sijsele, Belgium, 8340
Hôpital de Jolimont
Soignies, Belgium, 7060
UCL Mont-Godinne
Yvoir, Belgium, 5530
Sponsors and Collaborators
University Hospital, Ghent
Roche Pharma AG
Investigators
Principal Investigator: Filip De Keyser, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided by University Hospital, Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Filip De Keyser, MD PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00938444     History of Changes
Other Study ID Numbers: 2009/190, ML22613
Study First Received: July 10, 2009
Last Updated: July 13, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Patients with moderate to severe RA

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014