Clinical trial NCT00938444: Evaluation of the BRADA and ABILHAND Questionnaires
Official title: Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Patients with moderate to severe RA
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2009-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe RA.

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.


Eligibility 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.

Primary outcomes:
measure: Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time.
timeFrame: after 24 weeks of treatment with tocilizumab
Secondary outcomes:
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Jan Palfijn
state: Antwerpen
city: Aalst
country: Belgium
facility: ASZ
city: Bouge
country: Belgium
facility: Clinique St. Luc
city: Brussel
country: Belgium
facility: CHU Brugmann
city: Brussel
country: Belgium
facility: UCL St. Luc
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: AZ Sint-Lucas
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Hasselt
country: Belgium
facility: Reuma Instituut
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Luik
country: Belgium
facility: CHU de Liège
city: Montignies-sur-Sambre
country: Belgium
facility: CH Notre Dame - R Fabiola
city: Ottignies
country: Belgium
facility: Clinique St. Pierre
city: Rocourt
country: Belgium
facility: Clinique St. Vincent
city: Roeselare
country: Belgium
facility: Heilig Hartziekenhuis
city: Sijsele
country: Belgium
facility: AZ Alma
city: Soignies
country: Belgium
facility: Hôpital de Jolimont
city: Yvoir
country: Belgium
facility: UCL Mont-Godinne
Study officials:
affiliation: University Hospital, Ghent
name: Filip De Keyser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.