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BIOlogical, Successful TapEring Prediction

BIOlogical, Successful TapEring Prediction - BIO-STEP study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42567
Enrollment
800
Registered
2015-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic arthritis RA Rheumatoid arthritis

Interventions

None listed

Sponsors

Sint Maartenskliniek
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Rheumatoid arthritis (clinical diagnosis of treating rheumatologist, fulfilled at any time point between start of the disease and inclusion, operationalized by DOT diagnosis 101), psoriatic arthritis (clinical diagnosis of treating rheumatologist, operationalized by DOT diagnosis 102 or 202) or spondyloarthritis (clinical diagnosis of treating rheumatologist, operationalized by DOT diagnosis 201) * Treatment with the standard dose of one of the following biologicals: abatacept, adalimumab, certolizumab, etanercept, golimumab or tocilizumab. * Start with a tapering attempt in the context of protocolled tapering in daily clinical practice. * Concomitant treatment with a conventional disease modifying antirheumatic drug (csDMARD) is permitted. * Age * 18 years and mentally competent * Informed consent * Ability to measure the study outcome in the patient (e.g. life expectancy >6 months, no planned relocation far away) * Ability to read and communicate well in Dutch

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

MeasureTime frame
Successful dose tapering at six months will be used as primary efficacy endpoint. This is operationalised as using a lower than standard dose and remaining in low disease activity or remission at six months.

Secondary

MeasureTime frame
Successful dose tapering at twelve months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)