Evaluation of the BRADA and ABILHAND Questionnaires

Ghent University Hospital (UZ)

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00938444

2009/190

ML22613

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

80 participants in 1 patient group

Patients with moderate to severe RA

Description:

Patients with moderate to severe RA treated with Tocilizumab