Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000025451
• Date of registration: 28/12/2016
• Prospective Registration: Yes
• Primary sponsor: Yokohama City University Hospital
• Public title: 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 - Clinical studies on discontinuation of infliximab and making the shift to cyclosporine for refractory uveitis of Behcet's disease
• Date of first enrolment: 2017/04/01
• Target sample size: 5
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029184
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Nobuhisa Mizuki
• Affiliation: Yokohama City University School of Medicine Department of Ophthalmology

• Name: Yasutsugu Ida
• Affiliation: Yokohama City University School of Medicine Department of Ophthalmology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

refractory uveitis of Behcet's disease

Intervention(s)

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.

Primary Outcome(s)

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.

Source(s) of Monetary Support

Ministry of Health, Labor and Welfare

Ethics review

Status: YES
Approval date: 21/03/2017
Contact:

[e-mail]

advanced medical research centear

045-787-2527

[e-mail]

Results

• Results available: Yes
• Date Posted: 22/05/2019
• Date Completed: 30/06/2018