Evaluation of the BRADA and ABILHAND Questionnaires

Rheumatoid Arthritis Clinical Trial

Official title:

Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938444
• Other study ID #: 2009/190
• Secondary ID: ML22613
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: July 13, 2011
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
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	UZ Gasthuisberg	Leuven
Belgium	CHU de Liège	Luik
Belgium	Jan Palfijn	Merksem	Antwerpen
Belgium	CH Notre Dame - R Fabiola	Montignies-sur-Sambre
Belgium	Clinique St. Pierre	Ottignies
Belgium	Clinique St. Vincent	Rocourt
Belgium	Heilig Hartziekenhuis	Roeselare
Belgium	AZ Alma	Sijsele
Belgium	Hôpital de Jolimont	Soignies
Belgium	UCL Mont-Godinne	Yvoir

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Roche Pharma AG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time.		after 24 weeks of treatment with tocilizumab	No

External Links

•   website of the University Hospital Ghent