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
NCT ID: NCT01551069
Last Updated: 2014-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2012-03-31
2014-04-30
Brief Summary
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\- 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HCQ
HCQ 200\~400mg, once daily, oral administration
hydroxychloroquine (Z0188)
Pharmaceutical form:tablet
Route of administration: oral
Placebo
HCQ-placebo, once daily, oral administration
Placebo
Pharmaceutical form:tablet
Route of administration: oral
Interventions
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hydroxychloroquine (Z0188)
Pharmaceutical form:tablet
Route of administration: oral
Placebo
Pharmaceutical form:tablet
Route of administration: oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 392017
Bunkyō City, , Japan
Investigational Site Number 392022
Bunkyō City, , Japan
Investigational Site Number 392011
Chuo-Ku, Kumamoto-Shi, , Japan
Investigational Site Number 392003
Chūōku, , Japan
Investigational Site Number 392001
Fuchu-Shi, , Japan
Investigational Site Number 392008
Iruma-Gun, , Japan
Investigational Site Number 392009
Iruma-Gun, , Japan
Investigational Site Number 392005
Itabashi-Ku, , Japan
Investigational Site Number 392014
Kamogawa, , Japan
Investigational Site Number 392019
Kanazawa, , Japan
Investigational Site Number 392007
Kitakyushu, , Japan
Investigational Site Number 392020
Maebashi, , Japan
Investigational Site Number 392012
Nagasaki, , Japan
Investigational Site Number 392010
Nagoya, , 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, , Japan
Investigational Site Number 392004
Wakayama, , Japan
Investigational Site Number 392016
Yokohama, , Japan
Countries
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References
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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.
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.
Other Identifiers
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U1111-1126-8072
Identifier Type: OTHER
Identifier Source: secondary_id
EFC12368
Identifier Type: -
Identifier Source: org_study_id
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