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

Recruiting

Conditions: Rheumatoid arthritis

Registration Number: NL-OMON24414

Lead Sponsor: Reade Rheumatology Research Institute

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 84

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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