Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: Clinical tapering strategyDrug: Step Wedge trial
- Registration Number
- NCT06528431
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm trial Clinical tapering strategy Single arm trial in patients with established RA who achieved clinical remission with subcutaneous injection of adalimumab in combination with MTX (methotrexate). Patients will undergo a tapering strategy based only on the clinical status (flare /no flare) during 12 months. Optimized tapering adalimumab Step Wedge trial An optimized tapering adalimumab strategy based on the disease activity and the adalimumab trough concentration. The tapering strategy will rely on the adalimumab trough concentration. Spacing will be performed only if adalimumab trough concentration is above the pre-specified concentration threshold
- Primary Outcome Measures
Name Time Method 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,
- Secondary Outcome Measures
Name Time Method Infection 15 months Number of infection
Trial Locations
- Locations (8)
Chu Reims
🇫🇷Reims, France
Chru Tours
🇫🇷Tours, France
Infirmerie Protestante
🇫🇷Caluire-et-Cuire, France
Chd Vendee
🇫🇷La Roche-sur-Yon, France
Hopital Philibert
🇫🇷Lomme, France
Chu Montpellier
🇫🇷Montpellier, France
Ap-Hp Pitie Salpetriere
🇫🇷Paris, France
Chu Saint Etienne
🇫🇷Saint-Étienne, France