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

May 12, 2014 updated by: Sanofi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Bunkyo-Ku, Japan
        • Investigational Site Number 392017
      • Bunkyo-Ku, Japan
        • Investigational Site Number 392022
      • Chuo-Ku, Japan
        • Investigational Site Number 392003
      • Chuo-Ku, Kumamoto-Shi, Japan
        • Investigational Site Number 392011
      • Fuchu-Shi, Japan
        • Investigational Site Number 392001
      • Iruma-Gun, Japan
        • Investigational Site Number 392008
      • Iruma-Gun, Japan
        • Investigational Site Number 392009
      • Itabashi-Ku, Japan
        • Investigational Site Number 392005
      • Kamogawa City, Japan
        • Investigational Site Number 392014
      • Kanazawa-Shi, Japan
        • Investigational Site Number 392019
      • Kitakyushu, Japan
        • Investigational Site Number 392007
      • Maebashi-Shi, Japan
        • Investigational Site Number 392020
      • Nagasaki-Shi, Japan
        • Investigational Site Number 392012
      • Nagoya-Shi, Japan
        • Investigational Site Number 392010
      • Nakagami-Gun, Japan
        • Investigational Site Number 392013
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392006
      • Sagamihara-Shi, Japan
        • Investigational Site Number 392018
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392002
      • Tomigusuku-Shi, Japan
        • Investigational Site Number 392023
      • Uruma-Shi, Japan
        • Investigational Site Number 392021
      • Wakayama-Shi, Japan
        • Investigational Site Number 392004
      • Yokohama-Shi, Japan
        • Investigational Site Number 392016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HCQ
HCQ 200~400mg, once daily, oral administration
Drug: hydroxychloroquine (Z0188)

Pharmaceutical form:tablet

Route of administration: oral

Other Names:
  • Plaquenil®
Other: Placebo
HCQ-placebo, once daily, oral administration
Drug: Placebo

Pharmaceutical form:tablet

Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
from baseline (at visit 2) to 16 weeks treatment (at visit 6)

Secondary Outcome Measures

Outcome Measure
Time Frame
A change in CLASI activity score
Time Frame: from baseline (at visit 2) to 52 weeks treatment (at visit 15)
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
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
7 timepoints during 52 weeks
QOL related to skin manifestations (skindex-29)
Time Frame: 4 timepoints during 52 weeks
4 timepoints during 52 weeks
Dose reduction of concomitant corticosteroid
Time Frame: From 16 weeks to 55 weeks after the initiation of the treatment
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
3 timepoints during 52 weeks
Global assessment by patient (skin)
Time Frame: 3 timepoints during 52 weeks
3 timepoints during 52 weeks
Immunological parameters
Time Frame: up to maximum of 13 timepoints during 52 weeks
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
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
14 timepoints during 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 9, 2012

First Posted (Estimate)

March 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 13, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC12368
  • U1111-1126-8072 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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