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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025451
Receipt No. 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 2019/07/03

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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
Email 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
Email iday@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
Email 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 Preinitiation
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
2019 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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