Trial record 1 of 437 for:
lupus
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 is currently recruiting participants.
Verified April 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01551069
First received: March 8, 2012
Last updated: April 11, 2013
Last verified: April 2013
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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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01551069
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
Locations
| Japan | |
| Investigational Site Number 392017 | Recruiting |
| Bunkyo-Ku, Japan | |
| Investigational Site Number 392022 | Recruiting |
| Bunkyo-Ku, Japan | |
| Investigational Site Number 392003 | Recruiting |
| Chuo-Ku, Japan | |
| Investigational Site Number 392011 | Recruiting |
| Chuo-Ku, Kumamoto-Shi, Japan | |
| Investigational Site Number 392001 | Recruiting |
| Fuchu-Shi, Japan | |
| Investigational Site Number 392008 | Recruiting |
| Iruma-Gun, Japan | |
| Investigational Site Number 392009 | Recruiting |
| Iruma-Gun, Japan | |
| Investigational Site Number 392005 | Recruiting |
| Itabashi-Ku, Japan | |
| Investigational Site Number 392014 | Recruiting |
| Kamogawa City, Japan | |
| Investigational Site Number 392019 | Recruiting |
| Kanazawa-Shi, Japan | |
| Investigational Site Number 392007 | Recruiting |
| Kitakyushu, Japan | |
| Investigational Site Number 392020 | Recruiting |
| Maebashi-Shi, Japan | |
| Investigational Site Number 392012 | Recruiting |
| Nagasaki-Shi, Japan | |
| Investigational Site Number 392010 | Recruiting |
| Nagoya-Shi, Japan | |
| Investigational Site Number 392013 | Recruiting |
| Nakagami-Gun, Japan | |
| Investigational Site Number 392006 | Recruiting |
| Sagamihara-Shi, Japan | |
| Investigational Site Number 392018 | Recruiting |
| Sagamihara-Shi, Japan | |
| Investigational Site Number 392002 | Recruiting |
| Shinjuku-Ku, Japan | |
| Investigational Site Number 392023 | Recruiting |
| Tomigusuku-Shi, Japan | |
| Investigational Site Number 392021 | Recruiting |
| Uruma-Shi, Japan | |
| Investigational Site Number 392004 | Recruiting |
| Wakayama-Shi, Japan | |
| Investigational Site Number 392016 | Recruiting |
| 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: | April 11, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Lupus Erythematosus, Cutaneous Lupus Erythematosus, Systemic Connective Tissue Diseases Skin Diseases Autoimmune Diseases Immune System Diseases Hydroxychloroquine Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 19, 2013