Arthritis, Rheumatoid
Conditions
Keywords
Arthritis, Rheumatoid, Adalimumab, Remission management, step wedge trial
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.
Interventions
DRUGClinical tapering strategy
Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months
DRUGStep 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
Sponsors
AAP MESSIDOR
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization comparing 2 therapeutic strategies
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Infection | 15 months | Number of infection |
Countries
France
Contacts
Primary ContactHubert MAROTTE, MD PhD
Backup ContactMadjid AKROUR
Outcome results
None listed