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

PHASE3CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

December 31, 2013

Study Completion Date

April 30, 2014

Conditions
Cutaneous Lupus Erythematosus-Systemic Lupus Erythematosus
Interventions
DRUG

hydroxychloroquine (Z0188)

"Pharmaceutical form:tablet~Route of administration: oral"

DRUG

Placebo

"Pharmaceutical form:tablet~Route of administration: oral"

Trial Locations (22)

Unknown

Investigational Site Number 392017, Bunkyō City

Investigational Site Number 392022, Bunkyō City

Investigational Site Number 392011, Chuo-Ku, Kumamoto-Shi

Investigational Site Number 392003, Chūōku

Investigational Site Number 392001, Fuchu-Shi

Investigational Site Number 392008, Iruma-Gun

Investigational Site Number 392009, Iruma-Gun

Investigational Site Number 392005, Itabashi-Ku

Investigational Site Number 392014, Kamogawa

Investigational Site Number 392019, Kanazawa

Investigational Site Number 392007, Kitakyushu

Investigational Site Number 392020, Maebashi

Investigational Site Number 392012, Nagasaki

Investigational Site Number 392010, Nagoya

Investigational Site Number 392013, Nakagami-Gun

Investigational Site Number 392006, Sagamihara-Shi

Investigational Site Number 392018, Sagamihara-Shi

Investigational Site Number 392002, Shinjuku-Ku

Investigational Site Number 392023, Tomigusuku-Shi

Investigational Site Number 392021, Uruma

Investigational Site Number 392004, Wakayama

Investigational Site Number 392016, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY