Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical tapering strategy, Step Wedge trial.
- Who it may be relevant to
- Registry conditions: Arthritis, Rheumatoid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Clinical tapering strategy
Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months - Drug 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
Primary outcome measures
- Rheumatoid arthritis flare-up [Time frame: 15 Months]
Secondary outcome measures (1)
- Infection [Time frame: 15 months]
Eligibility criteria
Inclusion criteria
- Patient over 18 years of age
- Patients with a diagnosis of RA according to ACR/EULAR 2010 criteria
- Remission according to DAS28<=2.6 for at least 6 months
- Patient treated with ADA for at least 6 months. The patient is treated according to one of the following two strategies:
- ADA 40 mg every two weeks (= every 14 days) according to the standard regimen
- or ADA 40 mg every 3 weeks (= every 21 days)
- A negative highly sensitive pregnancy test for women of Childbearing Potential\*
- Affiliated person or beneficiary of a social security scheme
- Informed consent signed by the patient after information
Exclusion criteria
- Incapacity or refusal to understand and / or sign informed consent to participate in the study.
- Existing pregnancy, lactation, or intended pregnancy within the next 15 months
- Fibromyalgia associated to RA
- Any dose of prednisone for RA treatment 6 months before inclusion
- Patient deprived of liberty or patient under guardianship or curator ship.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 8 centers
- Infirmerie Protestante — Caluire-et-Cuire
- Chd Vendee — La Roche-sur-Yon
- Hopital Philibert — Lomme
- Chu Montpellier — Montpellier
- Ap-Hp Pitie Salpetriere — Paris
- Chu Reims — Reims
- Chu Saint Etienne — Saint-Etienne
- Chru Tours — Tours
Identifiers
NCT: NCT06528431 · 24CH046 · 2024-514313-35-00