Clinical trial NCT01551069: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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.

Primary outcomes:
measure: A change in CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index) activity score
timeFrame: from baseline (at visit 2) to 16 weeks treatment (at visit 6)
Secondary outcomes:
measure: A change in CLASI activity score
timeFrame: from baseline (at visit 2) to 52 weeks treatment (at visit 15)
measure: BILAG (British Isles Lupus Assessment Group) index to be conducted in patients complicated with SLE
timeFrame: 7 timepoints during 52 weeks
measure: 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
timeFrame: 7 timepoints during 52 weeks
measure: QOL related to skin manifestations (skindex-29)
timeFrame: 4 timepoints during 52 weeks
measure: Dose reduction of concomitant corticosteroid
timeFrame: From 16 weeks to 55 weeks after the initiation of the treatment
measure: Global assessment by investigator (skin and other)
timeFrame: 3 timepoints during 52 weeks
measure: Global assessment by patient (skin)
timeFrame: 3 timepoints during 52 weeks
measure: Immunological parameters
timeFrame: up to maximum of 13 timepoints during 52 weeks
measure: Number of patients with serious adverse events / adverse events
timeFrame: up to a maximum of 59 weeks
measure: Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination)
timeFrame: 14 timepoints during 52 weeks
Other outcomes:
Locations:
city: Bunkyo-Ku
country: Japan
facility: Investigational Site Number 392017
city: Bunkyo-Ku
country: Japan
facility: Investigational Site Number 392022
city: Chuo-Ku, Kumamoto-Shi
country: Japan
facility: Investigational Site Number 392011
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392003
city: Fuchu-Shi
country: Japan
facility: Investigational Site Number 392001
city: Iruma-Gun
country: Japan
facility: Investigational Site Number 392008
city: Iruma-Gun
country: Japan
facility: Investigational Site Number 392009
city: Itabashi-Ku
country: Japan
facility: Investigational Site Number 392005
city: Kamogawa City
country: Japan
facility: Investigational Site Number 392014
city: Kanazawa-Shi
country: Japan
facility: Investigational Site Number 392019
city: Kitakyushu
country: Japan
facility: Investigational Site Number 392007
city: Maebashi-Shi
country: Japan
facility: Investigational Site Number 392020
city: Nagasaki-Shi
country: Japan
facility: Investigational Site Number 392012
city: Nagoya-Shi
country: Japan
facility: Investigational Site Number 392010
city: Nakagami-Gun
country: Japan
facility: Investigational Site Number 392013
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392006
city: Sagamihara-Shi
country: Japan
facility: Investigational Site Number 392018
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392002
city: Tomigusuku-Shi
country: Japan
facility: Investigational Site Number 392023
city: Uruma-Shi
country: Japan
facility: Investigational Site Number 392021
city: Wakayama-Shi
country: Japan
facility: Investigational Site Number 392004
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number 392016
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
citation: Yokogawa N, Eto H, Tanikawa A, Ikeda T, Yamamoto K, Takahashi T, Mizukami H, Sato T, Yokota N, Furukawa F. Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus: A Multicenter, Double-Blind, Randomized, Parallel-Group Trial. Arthritis Rheumatol. 2017 Apr;69(4):791-799. doi: 10.1002/art.40018.