Prediction of individual treatment response to biologics by ex-vivo immunological testing in rheumatoid arthritis

Prediction of individual treatment response to biologics by ex-vivo immunological testing in rheumatoid arthritis - BIO-TOP study: Biologic Individual Optimized Treatment Outcome Prediction

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41052

Enrollment

400

Registered

2014-04-30

Start date

2014-06-12

Completion date

Unknown

Last updated

2025-03-24

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion) • Patients with RA who start with (or switch to) a biologic (including abatacept, adalimumab, etanercept, rituximab and tocilizumab) • Concomitant treatment with conventional DMARDs and/or NSAIDs is permitted • Age >= 18 years • 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: None

Design outcomes

Primary

Measure	Time frame
Primary outcome is the European League against Rheumatism (EULAR) good response criteria (DAS28CRP 1.2 compared to baseline), 3 months after the start of treatment with one of the above biologics.	—

Secondary

Measure	Time frame
Secondary outcomes include the *DAS28CRP compared to baseline and the ACR/EULAR remission criteria, 3 and 6 months after the start of treatment with one of the above biologics.	—

Countries

Netherlands

Outcome results