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Evaluating patient reported outcomes in the treatment practice of patients with rheumatoid arthritis


- candidate number15333
- NTR NumberNTR4155
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-aug-2013
- Secondary IDs13-N-100 METC ATRIUM ORBIS ZUYD
- Public TitleEvaluating patient reported outcomes in the treatment practice of patients with rheumatoid arthritis
- Scientific TitleEvaluating patient reported outcomes in the treatment practice of patients with rheumatoid arthritis
- ACRONYM
- hypothesisThe validated health assessment questionnaire (HAQ) such as the RAPID3, gives the rheumatologist the opportunity to have a more frequent and objective view on the effectivity and safety of the treatment. There is a relation between the RAPID3 and the DAS28 in clinical practice.
- Healt Condition(s) or Problem(s) studiedPatient reported outcomes, Rheumatoid arthritis, Intensive counselling
- Inclusion criteriaAdults with reumatoïde artritis treated with biologicals, such as TNFα-blockers (etanercept, adalimumab, infliximab etc.), interleukine-I-blockers, the B-celblocker rituximab, and the T-celactivationblocker and anti CTLA4 (abatacept).
- Exclusion criterianon RA patients, no biological treatment, non adult,
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 10-sep-2013
- planned closingdate1-jun-2014
- Target number of participants300
- InterventionsN/A
- Primary outcomePatient reported outcomes (RAPID-3) and DAS28
- Secondary outcomeSide effects
- Timepoints% with Routine Assessment of Patient Index Data with 3 measures (RAPID3) Timepoints: 4 times a year. % with Disease Activity Score in 28 joints (DAS28) Timepoints: 4 times a year.
- Trial web sitewww.sermos.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThis is a prospective observational study, addressing the relationship between DAS28 scores and RAPID3 questionnaires during the treatment of rheumatoid arthritis in adults. Four rheumatologists each assessed patients with rheumatoid arthritis in “real time” clinical care. The rheumatologist or nurse practioner performed a 28-joint count. Patients,recruited in the Netherlands, are emailed and asked to complete the RAPID3 questionnaire. The questionnaire takes 5-10 minutes to complete. The performed RAPID3 will be compared with the DAS28 on a 0-30 versus 1-10 scale. Scores are classified as high activity, moderate activity, low activity, and remission according to the DAS28 and RAPID3 scores. The DAS28 and RAPID3 scores will be statistically compared with a spearman’s rank correlation and with Cohen's kappa coefficient. The questionnaire is processed by an online data portal, which is protected and certified with ISO 9001/ ISO 27001.
- Main changes (audit trail)
- RECORD30-aug-2013 - 22-sep-2013


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