JPRN-jRCTs061220030
Active, not recruiting
Phase 2
Prospective study of the efficacy and safety of mycophenolate mofetil in patients with noninfectious uveitis and scleritis
Kiuchi Yoshiaki0 sites10 target enrollmentJune 9, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kiuchi Yoshiaki
- Enrollment
- 10
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age at the time of consent acquisition is 18 years or older
- •2\) Patients who can go to the outpatient clinic every 4 to 12 weeks after the start of administration
- •3\) Patients who have written consent to participate in this study
- •4\) Non\-infectious uveitis (intermediate, anterior intermediate, posterior, panuveitis) with a history of at least one eye
- •5\) At least one eye with active eye inflammation for 90 days or more, SUN criteria, over 2 cells in the anterior chamber, over 2 vitreous opacity, retinal choroidal lesions
- •6\) Patients who are visiting our hospital for at least one of the following.
- •If there is an activity of eye inflammation even after administration of prednisolone, equivalent to 1
- •mg/ kg, for 4 weeks.
- •When the anti\-inflammatory effect is obtained by oral prednisolone treatment equivalent to 0\.5\-1mg/ kg and the relapse of inflammation due to the gradual decrease in oral administration is within 90 days before registration.
- •If oral steroids are more than 10 mg/day are required 90 days before registration.
Exclusion Criteria
- •1\) Infectious uveitis
- •2\) Patients who cannot see through the fundus due to binocular cataract, corneal opacity, post\-iris adhesion, etc.
- •3\) Chronically low intraocular pressure in both eyes, IOP less than 5 mmHg, 3 months
- •4\) Patients who underwent endovascular surgery within 3 months before the start of administration of this drug.
- •5\) Patients who received immunosuppressive agents other than steroids within 12 months before the start of administration of this drug.
- •6\) Patients positive for hepatitis virus and tuberculosis syphilis.
- •7\) In patients with severe renal disease, serum Cr 1\.5 mg / dL or higher or CKD stage 3b or higher.
- •8\) Patients with systemic autoimmune disease.
- •9\) Patients with the following complications, Liver disease, mental illness, seizure and paroxysmal disease, heart disease due to other causes.
- •10\) Patients who have had serious side effects with immunosuppressants in the past.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Prospective study on the efficacy and safety of anamorelin for cachexia and identification of predictors of efficacynon small cell lung cancerJPRN-UMIN000045059Department of Respiratory Medicine, Japanese Red Cross Medical Center35
Completed
Not Applicable
A prospective study of the efficacy and safety of Denosumab for the prevention of osteoporosis in malignant lymphoma patients treated with prednisolone-containing chemotherapyMalignant LymphomaJPRN-UMIN000012362Department of Medical Oncology and Hematology, Sapporo Medical University, School of Medicine30
Recruiting
Not Applicable
A prospective study of the efficacy and safety of preoperative chemotherapy with gemcitabine+nab-paclitaxel therapy for resectable pancreatic body and tail cancer with splenic arteriovenous invasion by image.pancreatic cancerJPRN-UMIN000040948Wakayama medical university49
Not yet recruiting
Not Applicable
A prospective study on the efficacy and safety of double stenting with a narrow covered self-expandable metallic stent (SEMS) for malignant distal bile duct stenosisJPRN-jRCT1052210158Shiomi Hideyuki20
Active, not recruiting
Phase 1
A prospective study of the safety and efficacy of the use of a Lipiodol Emulsion for the embolization of inflammatory hypervascularizations observed in patients with articular or abarticular pain in the knee - LipioJoint 1EUCTR2020-002206-10-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)22