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Preliminary report have demonstrated that methotrexate induces an anti bio-medicament tolerization whan administrated just before the first administration of the bio-medicament. Once this tolerization is obtained it seems useless to continue the methotrexate because this treatment has no efficacity in cases of spondyloarthritis.
spondyloarthritis are treated in first intention by NSAIDs but in case of inefficacity biotherapies that inhib the TNF are used. Adalimumab is the most used anti TNF in this indication. Monoclonal antibody uses in therapy is immunogene, and there is a clear link between increase of anti drug antibody and in one hand decrease of drug serum concentration and in an other failure of the therapeutic response. With adalimumab there is an apparition of ADAb in 30%. There are reports suggesting that adding methotrexate to the therapy in a specific timeline allow to prevent the immunization. A previous study shows that association in long terms between methotrexate and adalimumab induce less immunized patients. The investigator's goal is to assess if two methotrexate subcutaneous injections at day 1 and 2 could prevent anti adalimumab antibodies formation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methotrexate + Adalimumab | Experimental | Experimental group : patients will receive 2 subcutaneous injections of methotrexate in addition of the usual adalimumab |
|
| Adalimumab | No Intervention | Reference group : patient will receive adalimumab as usual to treat spondyloarthritis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Patients randomized in this arm will have one subcutaneous injection of methotrexate 15min before and one 24h after their first injection of adalimumab prescribed as usual |
| Measure | Description | Time Frame |
|---|---|---|
| serum concentrations of ADAb anti adalimumab | To assess if 2 subcutaneous injections of methotrexate could prevent anti adalimumab antibodies formation at month 6 in patients with spondyloarthritis | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| residual serum concentration of adalimumab | To compare trough levels of adalimumab at month 1, 3, 6 and 12 in the 2 groups. | At 1, 3, 6 and 12 months |
| serum concentrations of ADAb anti adalimumab |
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Inclusion criteria :
Exclusion criteria :
Contraindication to methotrexate
Previous treatment with adalimumab
Steroids more than 10mg/day of prednisone equivalent
Previous treatment with:
Current immunosuppressive drugs except methotrexate
Current and proven pregnancy
Project of pregnancy in the next 3 months following inclusion
Legal safeguards
Inclusion in another interventional research project
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| Name | Affiliation | Role |
|---|---|---|
| gaetane Nocturne | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Pellegrin | Bordeaux | France | ||||
| Hopital Ambroise Paré |
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To compare the percentage of immunized patients at month 1, 3 and 12 in the 2 groups
| At 1, 3 and 12 months |
| Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events as assessed by the number of AE and SAE related to the treatment that occur during the participation of the patient | At 1, 3, 6 and 12 months |
| Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using ASDAS (Ankylosing Spondylitis Disease Activity Score) score. | A therapeutic efficacity will be described as a clinical pertinent change of ASDAS : Ankylosing Spondylitis Disease Activity Score (at least 1,1 point) (a higher score means a worse outcome) | At 3, 6 and 12 months |
| Comparison of Adalimumab Therapeutic efficacity in term of Activity disease using BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) score. | A therapeutic efficacity will be described as a clinical pertinent change of BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (0 to 50 points - a higher score means a worse outcome) | At 3, 6 and 12 months |
| Comparison of Adalimumab Therapeutic efficacity in term of therapeutic maintenance | Assess by Number of patient who didn't switch treatment | At 3, 6 and 12 months |
| Comparison of Adalimumab Therapeutic efficacity in term of nonsteroidal anti inflammatory drugs ' reduction | Assess by ASAS-NSAIDS score (Assessment of SpondyloArthritis international Society - nonsteroidal antiinflammatory drugs) (minimum 0. a higher score means a worse outcome) | At 3, 6 and 12 months |
| Boulogne-Billancourt |
| France |
| Hopital La Cavale Blanche | Brest | France |
| CHU Trousseau | Chambray-lès-Tours | France |
| CH Sud Francilien | Corbeil-Essonnes | France |
| Hopital Mondor | Créteil | France |
| Kremlin Bicetre hospital | Le Kremlin-Bicêtre | France |
| CH Le Mans | Le Mans | France |
| Hopital Saint Philibert | Lille | France |
| CHU Nantes | Nantes | France |
| CHR Orléans | Orléans | France |
| Hopital Bichat | Paris | France |
| Hopital Cochin | Paris | France |
| Hopital la Pitié Salpétrière | Paris | France |
| Hopital Saint Antoine | Paris | France |
| CH Pontoise | Pontoise | France |
| CHU Rouen | Rouen | France |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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