UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025670 |
|---|---|
| Receipt number | R000029230 |
| Scientific Title | Evaluation of uveoretinitis associated with Behcet's disease after discontinuation of successful infliximab therapy |
| Date of disclosure of the study information | 2017/01/16 |
| Last modified on | 2017/01/13 15:35:10 |
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Basic information
Public title
Evaluation of uveoretinitis associated with Behcet's disease after discontinuation of successful infliximab therapy
Acronym
Evaluation of uveoretinitis associated with Behcet's disease after discontinuation of successful infliximab therapy
Scientific Title
Evaluation of uveoretinitis associated with Behcet's disease after discontinuation of successful infliximab therapy
Scientific Title:Acronym
Evaluation of uveoretinitis associated with Behcet's disease after discontinuation of successful infliximab therapy
Region
| Japan |
Condition
Condition
Uveoretinitis associated with Behcet's disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the activity of uveoretinitis associated with Behcet's disease after discontinuation of successful infliximab therapy
Basic objectives2
Others
Basic objectives -Others
Evaluation of visual acuity, frequency of ocular attack
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of frequency of ocular attacks
Key secondary outcomes
Evaluation of visual acuity, fluorescein angiography, extraocular symptoms
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
1) Patients with low activity of ocular inflammation for at least 2 years before infliximab discontinuation
2)Patients with low levels of retinal vascular leakage before infliximab discontinuation
3)Patients with low activity of systemic symptoms
Key exclusion criteria
1)Patients with shortening of the interval between infliximab infusions
2)Patients with poor visual acuity during remission
3)Patients with neuro-Behcet's disease, intestinal Behcet's disease, vascular Behcet's disease
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Annabelle A Okada |
Organization
Kyorin University School of Medicine
Division name
Ophthalmology
Zip code
Address
6-20-2 Shinkawa, Mitaka,Tokyo
TEL
0422-47-5511
okada@eye-center.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Keino |
Organization
Kyorin University School of Medicine
Division name
Ophthalmology
Zip code
Address
6-20-2 Shinkawa, Mitaka,Tokyo
TEL
0422-47-5511
Homepage URL
keino@eye-center.org
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
杏林大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Three patients successfully treated with IFX for Behcet's disease uveoretinitis maintained remission for 6 months after discontinuation of their IFX therapy.
Management information
Registered date
| 2017 | Year | 01 | Month | 14 | Day |
Last modified on
| 2017 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029230
