No registrations found.
ID
Source
Health condition
Patient Reported Outcomes, PROs
Rheumatoid Arthritis, RA
Intensive outpatient management
Tight Control
Treat to target (T2T)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient reported outcomes (RAPID-3) and DAS28
Secondary outcome
Side effects
Background summary
This 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.
Study objective
The 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.
Study design
% 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.
Intervention
N/A
[default]
The Netherlands
[default]
The Netherlands
Inclusion criteria
Adults 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 criteria
non RA patients, no biological treatment, non adult,
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3983 |
| NTR-old | NTR4155 |
| Other | METC ATRIUM ORBIS ZUYD : 13-N-100 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |