Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): a blinded randomized superiority trail

Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): a blinded randomized superiority trail - ADDORA-switch

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52747

Enrollment

Registered

2019-09-24

Start date

2020-07-31

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Rheumatoide arthritis

Interventions

Patients are randomly assigned to usual care or *drug concentration* guided switch. When randomized to the usual care group, patients are switched to TNFi (etanercept, infliximab, golimumab or certo

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis patient, according to ACR 1987/2010 criteria; Failed treatment with adalimumab (defined as DAS28-CRP >2,9) and not treated with a subsequent biological DMARD (bDMARD) or target synthetic DMARD (tsDMARD) Who has agreed to participate (written informed consent); Age 18 years or older. Received adalimumab for at least 10 weeks in standard dosing (40mg subcutaneously every other week, either in monotherapy or combined with methotrexate or leflunomide) Stop adalimumab due to inefficacy, either alone or combined with side effects

Exclusion criteria

Exclusion criteria: Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation Life expectancy shorter than follow-up period of the study; No possibility to safely receive an TNF-inhibitor or a non-TNF-inhibitor ' Treatment with another TNF inhibitor prior to adalimumab Treatment with all non-TNFi options (abatacept, rituximab, sarilumab, tocilizumab, baricitinib, filgotinib, upadacitinib or tofacitinib) prior to adalimumab

Design outcomes

Primary

Measure	Time frame
The primary study endpoint is the difference in mean time weighted DAS28-CRP after 24 weeks.	—

Secondary

Measure	Time frame
• percentage of patients with good or moderate response according the EULAR response criteria after 12 and 24 weeks of treatment • percentage of patients with minimal disease activity (DAS28-CRP	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)