UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027733 |
|---|---|
| Receipt number | R000031570 |
| Scientific Title | Post-marketing surveillance for refractory uveoretinitis associated with Behcet's disease under Remicade treatment |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2017/06/12 18:15:17 |
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Basic information
Public title
Post-marketing surveillance for refractory uveoretinitis associated with Behcet's disease under Remicade treatment
Acronym
PMS of Remicade for refractory uveoretinitis associated with Behcet's disease
Scientific Title
Post-marketing surveillance for refractory uveoretinitis associated with Behcet's disease under Remicade treatment
Scientific Title:Acronym
PMS of Remicade for refractory uveoretinitis associated with Behcet's disease
Region
| Japan |
Condition
Condition
Behcet's disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Specified Drug Use Survey is implemented to collect and evaluate information on the safety and efficacy of the Remicade for patients with refractory uveoretinitis associated with Behcet's disease under actual use conditions for the treatment of the disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of adverse drug reactions, and efficacies (physician global assessment, incidence of ocular attacks, and corrected visual acuity)
Key secondary outcomes
Correlation factors of the safety and efficacy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with refractory uveoretinitis associated with Behcet's disease who use Remicade (Limited to those having inadequate response to conventional therapy)
Key exclusion criteria
Patients who meet "CONTRAINDICATIONS" to the use of Remicade
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Kubo |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Ikuyaku. Integrated Value Development Division, Medical Science Department
Zip code
Address
3-2-10, Dosho-machi,Chuo-ku, Osaka, 541-8505, Japan
TEL
06-6205-5362
kubo.hajime@mm.mt-pharma.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Yano |
Organization
Mitsubishi Tanabe Pharma Corporation
Division name
Ikuyaku. Integrated Value Development Division, Medical Affairs I Department
Zip code
Address
3-2-10, Dosho-machi,Chuo-ku, Osaka, 541-8505, Japan
TEL
06-6205-5614
Homepage URL
yano.toshiro@mc.mt-pharma.co.jp
Sponsor or person
Institute
Mitsubishi Tanabe Pharma Corporation
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corperation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 12 | 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
| 2007 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 17 | Day |
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2017 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031570
