Evaluation of the BRADA and ABILHAND Questionnaires

July 13, 2011 updated by: University Hospital, Ghent

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium, 9300
        • ASZ
      • Bouge, Belgium, 5004
        • Clinique St. Luc
      • Brussel, Belgium, 1020
        • CHU Brugmann
      • Brussel, Belgium, 1200
        • UCL St. Luc
      • Edegem, Belgium, 2650
        • UZA
      • Gent, Belgium, 9000
        • AZ Sint-Lucas
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Hasselt, Belgium, 3500
        • Reuma Instituut
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • Uz Gasthuisberg
      • Luik, Belgium, 4000
        • CHU de Liege
      • Montignies-sur-Sambre, Belgium, 6061
        • CH Notre Dame - R Fabiola
      • Ottignies, Belgium, 1340
        • Clinique St. Pierre
      • Rocourt, Belgium, 4000
        • Clinique St. Vincent
      • Roeselare, Belgium, 8800
        • Heilig Hartziekenhuis
      • Sijsele, Belgium, 8340
        • AZ Alma
      • Soignies, Belgium, 7060
        • Hôpital de Jolimont
      • Yvoir, Belgium, 5530
        • UCL Mont-Godinne
    • Antwerpen
      • Merksem, Antwerpen, Belgium, 2170
        • Jan Palfijn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with moderate to severe RA.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with moderate to severe RA
Patients with moderate to severe RA treated with Tocilizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time.
Time Frame: after 24 weeks of treatment with tocilizumab
after 24 weeks of treatment with tocilizumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Filip De Keyser, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/190
  • ML22613

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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