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Patients with spondyloarthritis, already treated by TNF blocker (adalimumab, etanercept or infliximab), and in stable low disease activity for at least 6 months, will be randomized into 2 groups: either keeping on their usual treatment with stable doses or progressive spacing of injections of their treatment. Follow-up will be done every 3 months during 12 months, with regular monitoring of disease activity and, in patients from the group "spacing", modification of the rhythm of injections according to health state and predefined protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maintain | Active Comparator | Continuation of usual treatment with fixed intervals according to standard recommendations |
|
| Spacing | Active Comparator | Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab, Etanercept, Golimumab or infliximab | Drug | Continuation of usual treatment with fixed intervals according to standard recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients remaining in low disease activity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medico-economic comparison of arms | The cost-efficacy ratio will be compared between the 2 arms (maintain and spacing). The objective is to see if the spacing of the treatments will allow a better tolerance and reduce the cost due to the treatments.To assess this cost-efficacy ratio, questionnaires will be used (quality of life SF36, medico-economic Euroqol). | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lapeyronie Hospital | Montpellier | 34295 | France |
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| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D000068800 | Etanercept |
| C529000 | golimumab |
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Adalimumab, Etanercept, Golimumab or infliximab | Drug | Progressive spacing of injections according to disease activity observed during follow-up and predefined protocol |
|
| D001168 |
| Arthritis |
| D007592 | Joint Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D007127 | Immunoglobulin Constant Regions |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |