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 Overview
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Brief Summary
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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
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Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)

Official Title
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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

Conditions
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Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: hydroxychloroquine (Z0188)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Patients diagnosed as cutaneous lupus erythematosus (CLE) Exclusion criteria: Patients receiving corticosteroid more than 15mg/day of the equivalent dose of prednisolone. Patients whose CLASI activity scores were less than 4 point at the initiation of Screening (Visit 1) and Day1 (Visit 2) (evaluated by a dermatology specialist). Patients whose fluctuations of CLASI activity scores were ≥20% between Visit 1 and Visit 2 (evaluated by a dermatology specialist). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HCQ<br>HCQ 200 400mg, once daily, oral administration | Drug: hydroxychloroquine (Z0188)<br>* Pharmaceutical form:tablet Route of administration: oral<br>* Other names: Plaquenil®;|
| Other: Placebo<br>HCQ-placebo, once daily, oral administration | Drug: Placebo<br>* Pharmaceutical form:tablet Route of administration: oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |