Adalimumab dose reduction aiming low drug levels with control of disease activity (ADDORA-LOW)

Phase 1

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

• Registration Number: EUCTR2019-001793-28-NL
• Lead Sponsor: Reade

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-05
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• rheumatoid arthritis patient, according to ACR 1987/2010 criteria;
• treated for at least 28 weeks with adalimumab
• adalimumab trough concentration >5mg/L
• 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 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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 other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the disease activity after dose reduction, aiming adalimumab concentration of 2 mg/L or 5 mg/L, in rheumatoid arthritis patients responding to adalimumab.;Secondary Objective: - to evaluate whether reducing adalimumab dose aiming a concentration of 2 mg/L is superior in costs savings compared to dose tapering aiming adalimumab concentration of 5 mg/L; <br>- to evaluate the algorithm used to achieve target concentration of 2 mg/L or 5 mg/L; <br>- to study the difference in cumulative incidence of flares between the two study groups ;Primary end point(s): The primary study endpoint is the difference in mean time weighted DAS28-CRP between week 0 and 28.;Timepoint(s) of evaluation of this end point: 28 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Difference in mean time weighted DAS28-CRP between study groups after 12 weeks<br>• Direct medical costs (medication, non-scheduled visits due flares, cost TDM testing) over 28 weeks<br>• Agreement between algorithm predicted and measured adalimumab concentrations at week 28.<br>• Number of flares and dose-interval shortenings after 28 weeks.<br>;Timepoint(s) of evaluation of this end point: 12 and 28 weeks