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IRCT20180110038297N1 IRCT 2018-05-02 Zanjan University of Medical Sciences Efficacy of Infliximab comparing with Cyclophosphamide in refractory uveitis in Behcet’s diseases Study of the Efficacy of Infliximab in comparison with Cyclophosphamide in refractory uveitis in Behcet’s diseases 2017-03-21 anticipated 20 Complete https://irct.ir/trial/29179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment as coin throw, Blinding description: In this study in order to blind the investigator, another person (a nurse) who does not participate in the study, will randomly assign both of Endoxan and Infliximab to each patient. Beyond this, drugs will be the same in color and equally used in serum to blind the patient. Patients’ information together with the type of drugs, will be stored in sealed envelopes and will be kept by the nurse until the end of follow-up and recording of the consequences or any serious complications for the patient. 3 Refractory uveitis in patients with Behcet. Intervention 1: Intervention group: The 10-membered group receiving infliximab by intravenous injection at a dose of 3 mg / kg in weeks 0, 2, 6 and then 8 weeks later (a total of four injections) with methotrexate 25 mg weekly (or cyclosporine 5 mg / kg daily), azathioprine is given as mg / kg 3 and daily prednisone 1 mg / kg. Intervention 2: Control group: Control group: The 10-person group received Endoxan with intravenous injection of 1000 mg per month (four consecutive months) with azathioprine (mg / kg 3) daily, methotrexate 25 mg weekly (or cyclosporine 5 mg / kg daily) and Prednisolone 1 mg / kg daily Became. Yes - There is a plan to make this available What will be shared: For patients, visual acuity, anterior uveitis, posterior uveitis and retinal vasculitis are measured before and during treatment, and the results are disseminated. When: Six months after the publication of the results To whom: Researchers working in academia and academia Conditions: In order to continue the study or do the same scientific research Where to obtain: Azadeh Behnam Ghader How to obtain: The interested scholar can receive the necessary information by email with the respective responsible person and provide the personal details and field of research after a maximum of one week. Comments:
public Azadeh Behnam Ghader
Education and treatment center of Valiasr, Valiasr square, Zanjan
Zanjan Iran (Islamic Republic of) 7797845157 +98 24 3377 0801 abehnamghader@zums.ac.ir Zanjan University of Medical Sciences scientific Azadeh Behnam Ghader
Education and treatment center of Valiasr, Valiasr square, Zanjan
Zanjan Iran (Islamic Republic of) 7797845157 +98 24 3377 0801 abehnamgheder@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Behcet’s disease Refractory uveitis Retinal vesiculitis 20 years 40 years Both Patient dissatisfaction Contraindications for administration of Infliximab or cyclophosphamide Non response to medication M35.2 Behcet's disease Treatment - Drugs Treatment - Drugs Intervention group: The 10-membered group receiving infliximab by intravenous injection at a dose of 3 mg / kg in weeks 0, 2, 6 and then 8 weeks later (a total of four injections) with methotrexate 25 mg weekly (or cyclosporine 5 mg / kg daily), azathioprine is given as mg / kg 3 and daily prednisone 1 mg / kg. Control group: Control group: The 10-person group received Endoxan with intravenous injection of 1000 mg per month (four consecutive months) with azathioprine (mg / kg 3) daily, methotrexate 25 mg weekly (or cyclosporine 5 mg / kg daily) and Prednisolone 1 mg / kg daily Became Total Inflammatory Activity Index. Timepoint: Measuring the total inflammatory activity index at the beginning of the study (prior to the intervention) and 2, 6 and 8 weeks after starting Infliximab, as well as measuring the index at the beginning of the study (before the intervention) and 1, 2 and 3 months later Start taking Endoxan. Method of measurement: Total inflammatory activity index is defined as right eye ([AU ×1] + [PU ×2] + [RV ×3]) + left eye ([AU ×1]+[PU ×2] + [RV ×3]) in which the PU stands for Posterior Uveitis, AU denotes Anterior Uveitis and RV shows Retinal Vasculitis. Total Adjusted Disease Activity Index. Timepoint: Measuring the total inflammatory activity index at the beginning of the study (prior to the intervention) and 2, 6 and 8 weeks after starting Infliximab, as well as measuring the index at the beginning of the study (before the intervention) and 1, 2 and 3 months later Start taking Endoxan. Method of measurement: Total Adjusted Disease Activity Index is defined as TIAI + right eye ([VA-10] ×2) + left eye ([VA-10] ×2) in which TIAI stands for Total inflammatory activity index and VA is the visual acuity. Zanjan University of Medical Sciences Approved 2017-01-17 Ethics committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences, Jomhouri Eslami Blvd, Azadi Square, Zanjan Zanjan Zanjan Iran (Islamic Republic of)