Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Clinical tapering strategy: Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months

Step Wedge trial: Step Wedge trial : At baseline, all the patients will receive in this study the standard adalimumab dosing regimen. At subsequent time points (steps), patients will begin the intervention of interest, here the tapering adalimumab strategy. The time at which a patient begins the intervention will be randomized. We fixed the time steps duration to 3 months that corresponds the frequency of there commended follow-up of RA patients

Study summary

Rheumatoid arthritis (RA) is the most common inflammatory joint disorder. Since twenty year and the use of synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and biological (b)DMARD, remission can be reached. When remission is obtained, the physician has no recommendations for managing a step-down, and future guidelines will be useful to assist the clinician. Recent data suggest that tapering is feasible, but with high risk of flares. Flares are less frequent when bDMARD blood concentration is high. But, the optimal adalimumab concentration to keep before a step of tapering no targeting personal is unknown.

Eligibility

Primary outcome measure(s)

• Rheumatoid arthritis flare-up — 15 Months
  The RA flare-up will be defined as previously by: 1. a disease activity score (DAS)28 that increase above 2.6 for patient previously in remission (DAS28≤2.6) and a DAS28 increase (ΔDAS28) of 0.6 or greater for patients with low disease activity (2.6\<DAS28\<3.2) : YES/NO 2. Use of a glucocorticoid for the symptoms of RA, regarless of the DAS28 : YES/NO DAS28 is calculated according to the formula that is composed of the number of tender joints (TJC) and swollen joints (SJC), patient's global assessment of disease activity on a visual analogue scale (PGA, 0-10), and C-reactive protein (CRP). Formula for calculating DAS28 using C-reactive protein (CRP) : DAS28-CRP=(0.56 × √TJC) + (0.28 × √SJC) + (0.014 × PGA \[mm\]) + (0.36 × ln(CRP in mg/L+1) + 0.96,

Trial sites (8)

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