UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004477 |
|---|---|
| Receipt number | R000005352 |
| Scientific Title | Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2015/06/20 10:44:25 |
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Basic information
Public title
Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk
Acronym
Hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome with annular erythema
Scientific Title
Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk
Scientific Title:Acronym
Hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome with annular erythema
Region
| Japan |
Condition
Condition
Systemic/cutaneous lupus erythematosus
Sjogren's syndrome
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hydroxychloroquine is used for patients with systemic/cutaneous lupus erythematosus or Sjogren's syndrome who have annular erythema on the face and/or trunk as a first choice in most countries other than Japan. In this study, we will evaluate the efficacy and safety of hydroxychloroquine for Japanese systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of size and/or color of erythematous lesion
Patient satisfaction assessed by visual analog scale
Key secondary outcomes
Assessment for safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hydroxychloroquine 200 mg will be administrated once daily. If insufficient, dosage can be escalated to 400 mg twice daily, but not exceed 6.5 mg/kg/day.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with systemic/cutaneous lupus erythematosus or Sjogren's syndrome who have annular erythema on the face and/or trunk that are resistant to steroid and/or tacrolimus treatment for external use.
2. Patients without retinopathy examined by ophthalmologist.
Key exclusion criteria
1. Patients with current or previous history of retinopathy.
2. Patients unable to take or unsupplied with 4-aminoquinoline.
3. Body weight is less than 30 Kg.
4. History of pregnancy or lactation.
5. Other patients who were judged to be ineligible for the study by an attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takehara |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Dermatology
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2000
takehara@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takehara |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Department of Dermatology
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2000
Homepage URL
takehara@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 29 | Day |
Last modified on
| 2015 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005352
