Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary: Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)
Sponsor: Sanofi

Current Primary Outcome: A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score [ Time Frame: from baseline (at visit 2) to 16 weeks treatment (at visit 6) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • A change in CLASI activity score [ Time Frame: from baseline (at visit 2) to 52 weeks treatment (at visit 15) ]
  • BILAG (British Isles Lupus Assessment Group) index to be conducted in patients complicated with SLE [ Time Frame: 7 timepoints during 52 weeks ]
  • RAPID 3 (Routine assessment of patient index data 3) to be conducted in patients complicated with SLE : daily life activity, pain associated with the original disease, patient's severity related to the original disease [ Time Frame: 7 timepoints during 52 weeks ]
  • QOL related to skin manifestations (skindex-29) [ Time Frame: 4 timepoints during 52 weeks ]
  • Dose reduction of concomitant corticosteroid [ Time Frame: From 16 weeks to 55 weeks after the initiation of the treatment ]
  • Global assessment by investigator (skin and other) [ Time Frame: 3 timepoints during 52 weeks ]
  • Global assessment by patient (skin) [ Time Frame: 3 timepoints during 52 weeks ]
  • Immunological parameters [ Time Frame: up to maximum of 13 timepoints during 52 weeks ]
  • Number of patients with serious adverse events / adverse events [ Time Frame: up to a maximum of 59 weeks ]
  • Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination) [ Time Frame: 14 timepoints during 52 weeks ]


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: March 8, 2012
Date Started: March 2012
Date Completion:
Last Updated: May 12, 2014
Last Verified: May 2014