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IRCT20130812014333N125 IRCT 2019-06-07 Kermanshah University of Medical Sciences Comparison of effectiveness and complication of rituximab and fingolimod in improvement disability motion One year comparison of effectiveness and complication of rituximab and fingolimod in multiple sclerosis (MS)patients 2018-05-10 anticipated 36 Complete https://irct.ir/trial/38158 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly Individually by random number table via code receipt. In this way, 36 cards which are identical in appearance will be provided and 18 of them are code 1, which specifies the intervention group, and the other are code 2, which specifies the control group.Then, anyone who is eligible to enter the study, randomly will select one of these cards(Participants will not be aware of the the type of intervention that will be assigned), Blinding description: In this study, clinical carer will be blinded to the study groups, the dosage of the drug and the manufacturer of the drug. 3 Multiple Sclerosis. Intervention 1: The first intervention group will receive 1000 mg of rituximab (manufactured by Takgene company) by injection. The injection will take about 6 hours, the second dose will be two weeks later, and then every 6 months for one year. Intervention 2: The second intervention group will receive 0.5 mg of fingolimod capsules(manufactured by Alhavi company). Then a daily oral administration of a fingolimod capsule for a minimum of 12 months will be prescribed. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 5 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: To receive the documentation, email send for update manager How to obtain: In a 25-day period, the documents will be sent e-mail Comments:
public Poona Ahmadi
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 poonaahmadi1@gmail.com Kermanshah University of Medical Sciences scientific Dr. Nazanin Razazian
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 3423 nrazazian@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Age between 18-55 years Negative pregnancy test in women of reproductive age At least one relapse in the past year, despite first-line Dimethyltryptamine treatment At least two relapse in the past two years, despite First-line Dimethyltryptamine treatment Active lesions (a new Type2 (T2) or Gadolinium(GAD) enhancement) and having two or more attacks in the past year despite the first-line treatment in recurrent patients Active lesions (new T2 lesions or GAD enhancement) and attack in patients who have the progressive form of illness 18 years 55 years Female Acute or chronic bacterial, viral or fungal infection Sensitivity to drug G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs The first intervention group will receive 1000 mg of rituximab (manufactured by Takgene company) by injection. The injection will take about 6 hours, the second dose will be two weeks later, and then every 6 months for one year. The second intervention group will receive 0.5 mg of fingolimod capsules(manufactured by Alhavi company). Then a daily oral administration of a fingolimod capsule for a minimum of 12 months will be prescribed. Disability motion. Timepoint: At the beginning of the study and one year after the study. Method of measurement: Base on Expanded Disability Scale Score(EDSS). Medicine complications. Timepoint: Start and during treatment. Method of measurement: Doctor observation and asking from patient. Relapse of the disease. Timepoint: Annually. Method of measurement: Diagnosis of the doctor. Kermanshah University of Medical Sciences Approved 2019-04-24 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Kermanshah Kermanshah Iran (Islamic Republic of)