Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-514313-35-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AAP MESSIDOR | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm trial | Experimental | 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. |
|
| Maintenance arm | No Intervention | Maintenance arm: the same adalimumab regimen | |
| Optimized tapering adalimumab | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical tapering strategy | Drug | Clinical Tapering strategy : Adalimumab injections will be progressively spaced out according to DAS28 assessment every 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rheumatoid arthritis flare-up | The RA flare-up will be defined as previously by:
| 15 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Number of infection | 15 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hubert MAROTTE, MD PhD | Contact | (0)4 77 12 76 49 | hubert.marotte@chu-st-etienne.fr | |
| Madjid AKROUR | Contact | (0)4 77 12 78 37 | +33 | madjid.akrour@chu-st-etienne.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Infirmerie Protestante | Recruiting | Caluire-et-Cuire | 69300 | France |
Not provided
Randomization comparing 2 therapeutic strategies
Not provided
Not provided
Not provided
Not provided
| Step Wedge trial | Drug | 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 |
|
| Chd Vendee | Recruiting | La Roche-sur-Yon | 85925 | France |
|
| Hopital Philibert | Recruiting | Lomme | 59160 | France |
|
| Chu Montpellier | Recruiting | Montpellier | 34295 | France |
|
| Ap-Hp Pitie Salpetriere | Recruiting | Paris | 75013 | France |
|
| Chu Reims | Not yet recruiting | Reims | 51100 | France |
|
| Chu Saint Etienne | Recruiting | Saint-Etienne | 42055 | France |
|
| Chru Tours | Not yet recruiting | Tours | 37170 | France |
|
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided