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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01551069
First received: March 8, 2012
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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.

Condition Intervention Phase
Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
Drug: hydroxychloroquine (Z0188)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A change in CLASI activity score [ Time Frame: from baseline (at visit 2) to 52 weeks treatment (at visit 15) ] [ Designated as safety issue: No ]
  • BILAG (British Isles Lupus Assessment Group) index to be conducted in patients complicated with SLE [ Time Frame: 7 timepoints during 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • QOL related to skin manifestations (skindex-29) [ Time Frame: 4 timepoints during 52 weeks ] [ Designated as safety issue: No ]
  • Dose reduction of concomitant corticosteroid [ Time Frame: From 16 weeks to 55 weeks after the initiation of the treatment ] [ Designated as safety issue: No ]
  • Global assessment by investigator (skin and other) [ Time Frame: 3 timepoints during 52 weeks ] [ Designated as safety issue: No ]
  • Global assessment by patient (skin) [ Time Frame: 3 timepoints during 52 weeks ] [ Designated as safety issue: No ]
  • Immunological parameters [ Time Frame: up to maximum of 13 timepoints during 52 weeks ] [ Designated as safety issue: No ]
  • Number of patients with serious adverse events / adverse events [ Time Frame: up to a maximum of 59 weeks ] [ Designated as safety issue: Yes ]
  • Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination) [ Time Frame: 14 timepoints during 52 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 103
Study Start Date: March 2012
Study Completion Date: April 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: HCQ
HCQ 200~400mg, once daily, oral administration
Drug: hydroxychloroquine (Z0188)

Pharmaceutical form:tablet

Route of administration: oral

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

Pharmaceutical form:tablet

Route of administration: oral


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551069

Locations
Japan
Investigational Site Number 392017
Bunkyo-Ku, Japan
Investigational Site Number 392022
Bunkyo-Ku, Japan
Investigational Site Number 392003
Chuo-Ku, Japan
Investigational Site Number 392011
Chuo-Ku, Kumamoto-Shi, Japan
Investigational Site Number 392001
Fuchu-Shi, Japan
Investigational Site Number 392009
Iruma-Gun, Japan
Investigational Site Number 392008
Iruma-Gun, Japan
Investigational Site Number 392005
Itabashi-Ku, Japan
Investigational Site Number 392014
Kamogawa City, Japan
Investigational Site Number 392019
Kanazawa-Shi, Japan
Investigational Site Number 392007
Kitakyushu, Japan
Investigational Site Number 392020
Maebashi-Shi, Japan
Investigational Site Number 392012
Nagasaki-Shi, Japan
Investigational Site Number 392010
Nagoya-Shi, Japan
Investigational Site Number 392013
Nakagami-Gun, Japan
Investigational Site Number 392006
Sagamihara-Shi, Japan
Investigational Site Number 392018
Sagamihara-Shi, Japan
Investigational Site Number 392002
Shinjuku-Ku, Japan
Investigational Site Number 392023
Tomigusuku-Shi, Japan
Investigational Site Number 392021
Uruma-Shi, Japan
Investigational Site Number 392004
Wakayama-Shi, Japan
Investigational Site Number 392016
Yokohama-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01551069     History of Changes
Other Study ID Numbers: EFC12368, U1111-1126-8072
Study First Received: March 8, 2012
Last Updated: May 12, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 30, 2014