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
- Conditions
- Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
- Interventions
- Drug: Placebo
- Registration Number
- NCT01551069
- Lead Sponsor
- Sanofi
- 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 Description
Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HCQ hydroxychloroquine (Z0188) HCQ 200\~400mg, once daily, oral administration Placebo Placebo HCQ-placebo, once daily, oral administration
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method A change in CLASI activity score 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 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 7 timepoints during 52 weeks QOL related to skin manifestations (skindex-29) 4 timepoints during 52 weeks Dose reduction of concomitant corticosteroid From 16 weeks to 55 weeks after the initiation of the treatment Global assessment by investigator (skin and other) 3 timepoints during 52 weeks Global assessment by patient (skin) 3 timepoints during 52 weeks Immunological parameters up to maximum of 13 timepoints during 52 weeks Number of patients with serious adverse events / adverse events up to a maximum of 59 weeks Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination) 14 timepoints during 52 weeks
Trial Locations
- Locations (22)
Investigational Site Number 392020
🇯🇵Maebashi-Shi, Japan
Investigational Site Number 392012
🇯🇵Nagasaki-Shi, Japan
Investigational Site Number 392013
🇯🇵Nakagami-Gun, Japan
Investigational Site Number 392017
🇯🇵Bunkyo-Ku, Japan
Investigational Site Number 392011
🇯🇵Chuo-Ku, Kumamoto-Shi, Japan
Investigational Site Number 392003
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392022
🇯🇵Bunkyo-Ku, Japan
Investigational Site Number 392001
🇯🇵Fuchu-Shi, Japan
Investigational Site Number 392009
🇯🇵Iruma-Gun, Japan
Investigational Site Number 392006
🇯🇵Sagamihara-Shi, Japan
Investigational Site Number 392008
🇯🇵Iruma-Gun, Japan
Investigational Site Number 392023
🇯🇵Tomigusuku-Shi, Japan
Investigational Site Number 392010
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392019
🇯🇵Kanazawa-Shi, Japan
Investigational Site Number 392005
🇯🇵Itabashi-Ku, Japan
Investigational Site Number 392018
🇯🇵Sagamihara-Shi, Japan
Investigational Site Number 392014
🇯🇵Kamogawa City, Japan
Investigational Site Number 392021
🇯🇵Uruma-Shi, Japan
Investigational Site Number 392004
🇯🇵Wakayama-Shi, Japan
Investigational Site Number 392002
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 392016
🇯🇵Yokohama-Shi, Japan
Investigational Site Number 392007
🇯🇵Kitakyushu, Japan