Using adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24414

Enrollment

Registered

2019-12-03

Start date

2020-07-31

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Rheumatoid arthritis

Interventions

Rheumatoid arthritis patients failing adalimumab treatment will be randomly assigned to switching strategy using drug concentration or usual care switching

Eligibility

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria; Recently 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); 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; Age 16 years or older.

Exclusion criteria

Exclusion criteria: Treatment with another TNF inhibitor prior to adalimumab Treatment with all non-TNFi options (abatacept, rituximab, sarilumab and tocilizumab) prior to adalimumab 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

Design outcomes

Primary

Measure	Time frame
The primary objective is to evaluate whether a switching strategy based on adalimumab concentration is superior to usual care switching in rheumatoid arthritis patients failing adalimumab treatment with regard to mean time weighted DAS28CRP at 28 weeks.	—

Secondary

Measure	Time frame
The secondary objectives include comparing response rates (EULAR good response), percentages of patients reaching low disease activity or remission (DAS28-CRP<2.9/2.4), percentages of non-responders to the subsequent biological, number and severity of adverse events and co-medication/rescue-medication use	—

Contacts

Public ContactSadaf Atiqi

Reade

s.atiqi@reade.nl0202421641

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)