Ulcerative Colitis. Ulcerative colitis
Conditions
Interventions
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.
Sponsors
Digestive Disease Research Institute of Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mayo score. Timepoint: At the beginning, 3 months and 9 months after entering this phase of study. Method of measurement: Colonoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSudabeh Alatab
Digestive Disease Research Institute
Outcome results
None listed