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IRCT20200412047047N1 IRCT 2020-05-19 Esfahan University of Medical Sciences comparison of the effect of Adalimumab and Infleximab in patients with Ankylosing Spondilitis presenting to Alzahra hospital comparison of the effect of Adalimumab and Infleximab in patients with Ankylosing Spondilitis presenting to Alzahra hospital 2020-05-21 anticipated 80 Complete https://irct.ir/trial/47118 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Patients entered to the study; 2 months and 4 months after the basic visit and starting treatment with one of the two drugs used in the study will go to the clinic and will be evaluated by a rheumatologist other than the patient's physician who is not aware of the patient's medication. The designed questionnaire will be completed and then the questionnaires will be analyzed by an analyst who is unaware of the type of medication received by the patients and the results will be compared. 3 Ankylosing Spondylitis. Intervention 1: Intervention group: Patients in group A will be treated with adalimumab once every 2 weeks after first visit at a dose of 40 mg per kilogram.Adalimumab under the brand name Cinnora, owned by the pharmaceutical company Orchid pharmed, will be used subcutaneously after the initial training; by the patients themselves. Intervention 2: Intervention group: Patients in group B will be treated with infliximab at a loading dose of 5 mg per kilogram in week 0-2-6 after first visit and then every 6 weeks. Infliximab, under the brand name Remicade, owned by the pharmaceutical compamy JANSSEN (the importer company is Behestan Daru) requires temporary hospitalization for use. After premedication with hydrocortisone and chlorpheniramine, every 100 mg of infliximab is diluted with 250 cc of normal saline solution and infused over 2 to 3 hours. After receiving the drug, the patient will be discharged if he is in good general condition and has stable vital signs. Yes - There is a plan to make this available What will be shared: Analyzed data will be available When: it will be available 6 months after publication To whom: this will be available only for those who work in academic institutions Conditions: in response to email requests, the analysis of data will be sent. using the analysis without indicating the reference is forbidden. Where to obtain: requests via email to the golshani@med.mui.ac.ir (responsible for scientific inquiries) How to obtain: after recieving email, it will be replied in one month. Comments:
public Marjan Golshani
Isfahan university of medical sciences, Hezarjarib street, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3261 8928 golshani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Marjan Golshani
Isfahan university of medical sciences, Hezarjarib street, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3261 8928 golshani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with known AS according to the American College of Rheumatology not responded to at least 3 months of treatment with 2 different NSAIDs candidates for initiating biological drugs. no limit no limit Both having contraindications to receiving anti-TNF drugs including active infection or being at high risk for infection past medical history of cancer past medical history of systemic lupus erythmatosis, past medical history of multiple sclerosis past medical history of an autoimmune disease. M45 Ankylosing spondylitis Treatment - Drugs Treatment - Drugs Intervention group: Patients in group A will be treated with adalimumab once every 2 weeks after first visit at a dose of 40 mg per kilogram.Adalimumab under the brand name Cinnora, owned by the pharmaceutical company Orchid pharmed, will be used subcutaneously after the initial training; by the patients themselves. Intervention group: Patients in group B will be treated with infliximab at a loading dose of 5 mg per kilogram in week 0-2-6 after first visit and then every 6 weeks. Infliximab, under the brand name Remicade, owned by the pharmaceutical compamy JANSSEN (the importer company is Behestan Daru) requires temporary hospitalization for use. After premedication with hydrocortisone and chlorpheniramine, every 100 mg of infliximab is diluted with 250 cc of normal saline solution and infused over 2 to 3 hours. After receiving the drug, the patient will be discharged if he is in good general condition and has stable vital signs. BASDAI score. Timepoint: Basic visit, 2 months and 4 months after starting biological drug. Method of measurement: Questionnaire filled by a rheumatologist. Schober test. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: measured by a rheumatologist by a meter. CRP level. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: laboratory. ESR. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: laboratory. Enthesitis. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: examination by a rheumatologist. Occiput-wall distance. Timepoint: Basic visit, 2 months and 4 months after starting biologic drug. Method of measurement: examination by a rheumatologist using a meter. Esfahan University of Medical Sciences Approved 2020-03-18 Ethics committe of esfahan university of medical sciences Isfahan university of medical sciences, Hezarjarib street, esfahan Isfahan Isfehan Iran (Islamic Republic of)