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IRCT20181217042020N1 IRCT 2019-02-10 Digestive Disease Research Institute of Tehran University of Medical Sciences Tofacitinib therapy in Ulcerative Colitis patients Evaluation of Tofacitinib efficacy for induction therapy in patients with Ulcerative Colitis 2018-12-22 anticipated 50 Complete https://irct.ir/trial/36231 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This study is the first study for evaluation of effectiveness of Tofacitinib (as a JAK inhibitor agent) in our country.Despite the availability of this drug in other countries, Tofacitinib has not been yet available for Ulcerative Colitis patients in our country. Implementation of this study could facilitate the introduction of this drug to our permitted list of medications and smooth the way for performing the phase III and IV of clinical trials for this intervention. 1-2 Ulcerative Colitis. Intervention group: Medication: Tofacitinib 5 mg; Dose: 20 mg/day (4 tablets); frequency: 2 times per day (2 tablets in the morning; two tablets in the evening); Duration: 2 months. Yes - There is a plan to make this available What will be shared: Data of participants: at the end of study and after publication of results, the file of the primary and secondary outcomes as well as demographic and past medical history of participants could be shared. the consent form: the approved consent form could be shared When: Start date of sharing:Three months after publication of results End date of sharing: Nine months after publication of results To whom: Academic researchers Conditions: In case academic researchers are interested in obtaining these data, they should contact (by official academic email) the scientific responsible of this study and ask for data. the data can not be used for publishing the paper Where to obtain: For requesting the data, thee academic researcher should contact by academic email the scientific responsible of the study Dr. Homayoun Vahedi dr_vahedi@yahoo.com How to obtain: The reason for requesting the data and type of use should be mentioned in request. if the conditions are satisfactory for the scientific responsible of study and other collaborators of the study, then the requested data will be shared. This process might take up to one month. Comments:
public Sudabeh Alatab
North Kargar street. shariati Hospital, Digestive Diseaase Research Institute
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۳۵ +98 21 8241 5000 sudabehalatab@yahoo.com Digestive Diseaase Research Institute of Tehran University of Medical Sciences scientific Dr. Homayoun Vahedi
North Kargar street, Shariati hospital, Digestive Disease Research Institute
Tehran Iran (Islamic Republic of) ۱۴۱۱۷۱۳۱۳۵ +98 21 8241 5000 homayoonvahedi@gmail.com Digestive Disease Research Institute of Tehran University of Medical Sciences Iran (Islamic Republic of) Age> 18 years old Known case of Ulcerative Colitis Mayo score ≥6 in last 4 months Rectal bleeding subscore of 1 to 3 in last 4 months Endoscopic subscore of 2 or 3 in last 4 months No clinical response or clinical remission (failed treatment) after ant TNF being used for at least 12- 14 weeks or Azathioporin used for at least 8-10 weeks Unacceptable side effects after Corticostroid, Azathioprine, Mercaptopurine, Infliximab, or Adalimumab therapy 18 years no limit Both 1- Abnormal chest x ray pregnant women or women who plan to become pregnant, Acute infection GFR< 60 ml/ min Known case of cancer, positive TB test (PPD/ or IGRA test) Being positive for tests: HBV, HCV, HIV, CMV K51 Ulcerative colitis Treatment - Drugs Intervention group: Medication: Tofacitinib 5 mg; Dose: 20 mg/day (4 tablets); frequency: 2 times per day (2 tablets in the morning; two tablets in the evening); Duration: 2 months Mayo score. Timepoint: At the beginning of enrollment and 2 months after start of intervention. Method of measurement: Colonoscopy. Lipid profile. Timepoint: At baseline and 2 months after intervention. Method of measurement: Enzymatic method. Liver function test. Timepoint: At baseline and 2 months after intervention. Method of measurement: Autoanalyser. ESR. Timepoint: At baseline and 2 months after intervention. Method of measurement: Autoanalyser. Digestive Disease Research Institute of Tehran University of Medical Sciences Approved 2018-11-03 Ethic committee of Digestive Disease Research Institute of Tehran University of Medical Sciences North Kargar street, Shariati Hospital, Digestive Disease Research Institute Tehran Tehran Iran (Islamic Republic of)