UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025451 |
|---|---|
| Receipt number | R000029184 |
| Scientific Title | Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease |
| Date of disclosure of the study information | 2016/12/28 |
| Last modified on | 2021/06/03 21:51:59 |
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Basic information
Public title
Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease
Acronym
Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease
Scientific Title
Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease
Scientific Title:Acronym
Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease
Region
| Japan |
Condition
Condition
refractory uveitis of Behcet's disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we withdraw Infliximab infusion therapy for refractory uveitis of Behcet's disease, and make the shift to Cyclosporin A. Long-term Infliximab administration has risks such as malignant lymphoma, tuberculosis, opportunistic infection, etc. With medical economics, withdrawal of Infliximab has advantages for patients. However, there are few reports on the withdrawal of Infliximab and it is cited as a future subject.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes is the proportion of cases in which Infliximab is reintroduced in one year from the start of Infliximab withdrawal. Because the number of cases is small, if the proportion of re-introduction of Infliximab is 20% or less, it is acceptable.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with Behcet's disease who has received Infliximab intravenous infusion treatment at 8 week intervals over a long period (over 4 years) and calm eye inflammation, shall be discontinued from infliximab and be changed to cyclosporine A oral administration. For cases in which uveitis can not be suppressed and infliximab is reintroduced, if it is 20% or less, it shall be acceptable. Cyclosporine A is started orally at 5 mg / kg / day orally twice a day from 6 weeks after the final Infiximab administration, the maintenance dose is 3 to 5 mg / kg / day, and if the clinical findings are stabilized, Losing weight little by little is judged by the research doctor . The target trough value should be less than 150 ng / ml. The observation period of cyclosporine administration is one year.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Infliximab intravenous treatment is performed for 8 weeks at long intervals (over 4 years)
2. Eye symptoms and extraocular symptoms are calm
3. Over 20 years old
Key exclusion criteria
1. Patients with kidney dysfunction
2. Patients with liver dysfunction
3. Patients with pancreatic dysfunction
4. Hypertension patients
5. Patients with infection
6. Patients with malignant tumors (such as malignant lymphoma) or a previous medical history
7. Patients during ultraviolet radiation therapy including PUVA therapy
8. Elderly (65 years and over)
9. Hepatitis B virus carrier, patient with hepatitis C virus carrier
10. Patients who are using contraindicated drugs in combination with cyclosporine,Living vaccine (dry live attenuated measles vaccine, dry live attenuated feline vaccine, oral raw polio vaccine, dry raw BCG, etc.), tacrolimus excluding external medicine (prograf), pitavastatin ), Rosuvastatin (crestor), bosentan (trakuria), aliskiren (radiolith), asnaprevir (sunbella), baniprevir (bani hep)
11. Other patients judged inappropriate by the research doctor
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University School of Medicine
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama JAPAN
TEL
045-787-2683
mizunobu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yasutsugu |
| Middle name | |
| Last name | Ida |
Organization
Yokohama City University School of Medicine
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama JAPAN
TEL
045-787-2683
Homepage URL
iday@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
advanced medical research centear
Address
3-9 Fukuura, Kanazawa-ku, Yokohama JAPAN
Tel
045-787-2527
sentan@yokohama-cu.ac.jp
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
| 2016 | Year | 12 | Month | 28 | 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
3
Results
The duration of infliximab for the 3 cases was an average of 7 years and 8 months, and the remission of ocular inflammation after introduction of infliximab was an average of 6 years and 8 months.
In all cases, there was no eye inflammation attack for 1 year, the eye activity score remained at 0, and there were no cases of reintroduction of infliximab.
However, all cases had relapsed systemic symptoms such as extraocular symptoms such as folliculitis,recurrent oral aphthae, and unknown fever.
Results date posted
| 2019 | Year | 05 | Month | 22 | Day |
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
| 2016 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029184
