Calendario›SNY›hydroxychloroquine
hydroxychloroquine
Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion
Ensayo de Sanofi en Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus (del registro, en inglés).
- Fase
- Fase 3
- Estado
- Completado
- Participantes
- 103
- Centros
- 22
- Fin del objetivo primario
- dic 2013
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en mar 2012.
Qué mide
A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score (from baseline (at visit 2) to 16 weeks treatment (at visit 6)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objective: \- To investigate the efficacy on skin manifestation of 16 weeks treatment of once daily regimen of hydroxychloroquine sulphate (HCQ) in patients with cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) with active skin manifestation (CLASI \[Cutaneous Lupus Erythematosus Disease Area and Severity Index\] activity score is ≥4) concomitant treatment with or without corticosteroid. Secondary Objectives: * To evaluate the efficacy on skin manifestation and the safety of 16 weeks treatment of once daily regiment of HCQ versus placebo as the reference group in patients with CLE and SLE with active skin manifestation (CLASI activity score is ≥4) concomitant treatment with or without corticosteroid. * To investigate the safety of 16 weeks treatment of once daily regiment of HCQ in patients with CLE and SLE with active skin manifestation concomitant treatment with or without corticosteroid. * To investigate the safety and efficacy of 52 weeks long-term treatment of once daily regimen of HCQ in patients with CLE and SLE - To investigate the influence of the dose reduction of corticosteroid on CLE and SLE patients treated with HCQ concomitant with corticosteroid * To investigate efficacy of once daily regimen of HCQ on systemic symptoms, musculoskeletal symptoms and immunological parameters in SLE patients.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01551069), actualizada en may 2014.