hydroxychloroquine (Z0188)
DrugPharmaceutical form:tablet
Route of administration: oral
Other names: Plaquenil®
Completed
NCT Number: 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
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.
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Investigational Site Number 392017, Bunkyō City, Japan
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About this study
Total 59 weeks (screening;4 weeks, treatment;52 weeks, Follow-up; 3 weeks)
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Placebo
DrugPharmaceutical form:tablet
Route of administration: oral
Primary outcomes
-
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)
Secondary outcomes
-
A change in CLASI activity score
Time frame: 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
-
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
-
QOL related to skin manifestations (skindex-29)
Time frame: 4 timepoints during 52 weeks
-
Dose reduction of concomitant corticosteroid
Time frame: 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
-
Global assessment by patient (skin)
Time frame: 3 timepoints during 52 weeks
-
Immunological parameters
Time frame: 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
-
Ophthalmologic examination (visual acuity examination, slit-lamp examination, funduscopic examination, visual field examination and color vision examination)
Time frame: 14 timepoints during 52 weeks
Sponsors and collaborators
Lead sponsor
Sanofi
Industry
Registry information
Official study 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
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2014
- First posted
- Mar 12, 2012
- Registry last updated
- May 13, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.