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IRCT20120524009844N8 IRCT 2020-10-20 Tabriz University of Medical Sciences Therapeutic Effects of Adalimumab in Patients with Resistant Psoriasis Therapeutic Effects of Adalimumab in Patients with Resistant Psoriasis Patients by DLQ and PASI Questionnaires 2020-06-21 anticipated 60 Complete https://irct.ir/trial/50991 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using even and odd numbers. The intervention group will be odd numbers and the control group will be even numbers. The number zero will be considered as an even. 3 Psoriasis. Intervention 1: Intervention group: At the beginning of the study, they will receive 80 mg of adalimumab. The next dose will be one week later (40 mg) and then every two weeks (40 mg) (the total duration of treatment will be two months). Intervention 2: Control group: Will receive routine psoriasis treatment including methotrexate and cyclosporine at a specific dose determined by a dermatologist (project manager). Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Mehdi Amirnia
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1540 6612 amirniam@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mehdi Amirnia
Faculty of medicine, Tabriz University of Medical Sciences, Golgasht st.
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 1540 6612 amirniam@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Confirmed pseuriasis Accepted Patients without responce to previous treatments Don’t use of other drugs and herbal supplments Resistance to atleast one systemic treatment 18 years no limit Both Allergy to Adalimumab Having active inflammation such as tuberculosis, malignancies and etc Neurological disorders Hematological disorders Moderate to severe heart failure Pregnant and breast feeding woman Mental retared patients L40 Psoriasis Treatment - Drugs Treatment - Drugs Intervention group: At the beginning of the study, they will receive 80 mg of adalimumab. The next dose will be one week later (40 mg) and then every two weeks (40 mg) (the total duration of treatment will be two months). Control group: Will receive routine psoriasis treatment including methotrexate and cyclosporine at a specific dose determined by a dermatologist (project manager). Disease severity. Timepoint: At the beginning of the study, 1, 2, 3 and 4 months after receiving the intervention. Method of measurement: Psoriasis Area Severity Index Score. Quality of life. Timepoint: Initiation of the study, 4 months after receiving the intervention. Method of measurement: Dermatologic Quality of Life Index. Tabriz University of Medical Sciences Approved 2020-08-10 Ethics Committee of Tabriz University of Medical Sciences Third floor, Central Building 2 , Tabriz Medical Sciences University, Gholgasht ave , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)