Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus Clinical Trial
Official title:
A Randomized, Double Blind, Baseline Controlled Study Using Placebo as Reference for Assessing the Efficacy and Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus in the Presence of Active Lupus Erythematosus Specific Skin Lesion
Primary 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.
Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks) ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment