|- candidate number||28244|
|- NTR Number||NTR6868|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-nov-2017|
|- Secondary IDs||P1660 METC Slotervaartziekenhuis en Reade|
|- Public Title||Biologicals and tsDMARDs in inflammatory rheumatic diseases: The Reade Rheumatology Registry|
|- Scientific Title||Biologicals and tsDMARDs in inflammatory rheumatic diseases: The Reade Rheumatology Registry|
|- Healt Condition(s) or Problem(s) studied||Inflammatory rheumatic disease, Targeted synthetic DMARD (tsDMARD), Biological|
|- Inclusion criteria||- Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis/non-radiographic axial spondyloarthritis, according to the treating rheumatologist;|
- Written informed consent.
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||24-nov-2016|
|- planned closingdate|
|- Target number of participants||0|
|- Primary outcome||Efficacy will be determined in comparison to baseline by comparing disease activity, patient reported outcomes, radiological progression and functional capacity during follow-up.|
Safety will be determined by the occurrence of side effects.
|- Secondary outcome||Changes in (bio)markers during treatment will be analyzed versus baseline.
|- Timepoints||Baseline (prior to treatment) and 1 month, 3-4 months, 6-7 months, 1 year, 1,5 year, 2 years and yearly thereafter. |
|- Trial web site||www.reade.nl and www.ams.rc.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. PhD. M.T. Nurmohamed|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. M.T. Nurmohamed|
|- Sponsor/Initiator ||Reade Center for Rehabilitation and Rheumatology|
(Source(s) of Monetary or Material Support)
|Reade Center for Rehabilitation and Rheumatology|
|- Brief summary||Rationale: 1) Biologicals and targeted synthetic Disease Modifying AntiRheumatic Drugs (tsDMARD) are approved in the Netherlands for the treatment of moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS)/non-radiographic axial spondyloarthritis (nrAxSpA). As efficacy in daily clinical practice can differ from the clinical (registration) trials, e.g. due to different patient groups, it is important to monitor the daily clinical practice. 2) Nowadays treatment of RA, PsA and AS (nrAxSpA) is to a large extent protocolized and aimed at achieving remission. After achieving remission it is important to taper or even stop the antirheumatic drugs to avoid unnecessary drug exposure. Identifying (bio)markers for treatment response, failure and successful tapering will improve treatment response.|
Objective: To determine the efficacy and safety of biological agents and tsDMARDs in rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis patients in daily clinical practice. In addition, prognostic (bio)markers for treatment response, failure and successful tapering will be identified.
Study design: Prospective observational cohort study in patients with RA, PsA, AS (nrAxSpA) who are treated with biologics or tsDMARDs or in whom treatment with these agents is initiated. Efficacy and safety data will be collected throughout the study.
Main study parameters: Efficacy will be determined in comparison to baseline by comparing disease activity, patient reported outcomes, radiological progression and functional capacity during follow-up.
Safety will be determined by the occurrence of side effects. Changes in (bio)markers during treatment will be analyzed versus baseline.
|- Main changes (audit trail)|
|- RECORD||21-nov-2017 - 15-dec-2017|