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IRCT20181217042020N2 IRCT 2019-03-12 Digestive Disease Research Institute of Tehran University of Medical Sciences Effects of Tofacitinib on Ulcerative Colitis patients Evaluation of the efficacy of Tofacitinib in maintenance therapy of patients with ulcerative colitis 2019-03-11 anticipated 40 Complete https://irct.ir/trial/36232 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This study is designed as the second phase of study entitled " Evaluation of Tofacitinib efficacy for induction therapy in patients with Ulcerative Colitis ". In that study, 50 patients aged 18 years and older who had moderate- to severe Ulcerative Colitis and didnot clinically respond to conventional therapy (didnot enter in clinical response or clinical remission phase) will recieve 20 mg / day Tofacitinib (Fanavaran Rojan Mohaghegh darou Co. ) for 2 months. Patients who clinically respond to Tofacitinib (assessed by biochemical and clinical assessment) will enter into second phase which is the present study. 1-2 Ulcerative Colitis. Intervention group: Medication: Tofacitinib 5 mg; Dose: 10 mg/day (2 tablets); frequency: 2 times per day (1 tablet in the morning; 1 tablet in the evening); Duration: 10 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
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8241 5000 sudabehalatab@yahoo.com Digestive Disease Research Institute scientific Dr. Homayoun Vahedi
Digestive Disease Research Institute, Shariati hospital, North Kargar street,
Tehran Iran (Islamic Republic of) 1411713135 +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 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 Being enrolled in phase 1 of study (induction therapy with Tofacitinib) Clinical response to induction therapy ( 2 months treatment duration) with Tofacitinib 18 years no limit Both 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: 10 mg/day (2 tablets); frequency: 2 times per day (1 tablet in the morning; 1 tablet in the evening); Duration: 10 months Mayo score. Timepoint: At the beginning, 3 months and 9 months after entering this phase of study. Method of measurement: Colonoscopy. Lipid profile. Timepoint: At the beginning, 3 months and 9 months after entering this phase of study. Method of measurement: Enzymatic method. Liver function test. Timepoint: At the beginning, 3 months and 9 months after entering this phase of study. Method of measurement: Autoanalyser. ESR. Timepoint: At the beginning, 3 months and 9 months after entering this phase of study. 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 Digestive Disease Research Institute, Shariati hospital, North Kargar street, Tehran Tehran Iran (Islamic Republic of)