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

Phase 1

• Conditions: rheumatoid arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-001754-25-NL
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-25
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

•rheumatoid arthritis patient, according to ACR 1987/2010 criteria;
•failed treatment with adalimumab (defined as DAS28-CRP >2,9)
•who has agreed to participate (written informed consent);
•age 18 years or older.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

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 TNFi or a non TNFi
•Treatment with all non-TNFi options (abatacept, rituximab, sarilumab and tocilizumab) prior to adalimumab

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate whether a switching strategy using adalimumab concentration (TDM) is superior to usual care in rheumatoid arthritis patients failing adalimumab treatment with regard to response rates;Secondary Objective: to evaluate the response rate after 16 weeks of treatment in both arms; to evaluate percentage of patients reaching minimal disease activity (DAS28-CRP<2.9) in both arms ;Primary end point(s): The primary study endpoint is the difference in mean time weighted DAS28-CRP after 28 weeks. ;Timepoint(s) of evaluation of this end point: 28 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 16 and 28 weeks;Secondary end point(s): •percentage of patients with good or moderate response according the EULAR response criteria after 16 and 28 weeks of treatment <br>•percentage of patients with minimal disease activity (DAS28-CRP<2.9) after 28 weeks<br>•percentage of non-responders to the subsequent biological after 28 weeks<br>•number of flares after 28 weeks<br>