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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00735-42 | Other Identifier | ID-RCB number, ANSM |
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| Name | Class |
|---|---|
| Région Nord-Pas de Calais, France | OTHER |
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This study is a biomedical, open label, therapeutic strategy, interventional, non-randomized, multicenter study to evaluate the non compliance to antimalarials in patients with systemic lupus in the Nord Pas-de-Calais region (FRANCE). It is conducted in two visits. These visits consist in obtaining blood sample, performing a clinical examination and filling in a questionnaire (Quality Of Life, Coping...).
The goal for the noncompliants patients is to guide them towards the therapeutic education with professionals (nurses and physicians).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Systemic Lupus | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic education | Other | This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease. |
| Measure | Description | Time Frame |
|---|---|---|
| measure of the frequency of patients with systemic lupus noncompliants to their antimalarials treatment. | baseline, at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| hydroxychloroquinémie | Monitoring of blood levels of hydroxychloroquinémie | between 6 months at 12 months |
| number of non- adherent patients | Identification of the number of non- adherent patients are being enrolled in Education Protocol Patient and number of sessions followed ; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hachulla, MD, PhD | University Hospital, Lille | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Hôpital Duchenne | Boulogne-sur-Mer | 62321 | France | |||
| CH Douai |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| at 12 months |
| quality of life scale Coping | scale Coping ( WCC-R Par COUSSON et al. (1996) ) scale MASRI, scale MMAS-8-item | baseline, at 12 months |
| Douai |
| 59507 |
| France |
| CH Dunkerque | Dunkirk | 59385 | France |
| CH du Dr Schaffner | Lens | 62307 | France |
| CHRU, Hôpital Huriez | Lille | France |
| Victor Provo Hospital | Roubaix | 59056 | France |
| Valenciennes hospital | Valenciennes | 59322 | France |