Effects of Tofacitinib on Ulcerative Colitis patients

Phase 1

Recruiting

Conditions: lcerative Colitis.
Ulcerative colitis

Registration Number: IRCT20181217042020N2

Lead Sponsor: Digestive Disease Research Institute of Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mayo score. Timepoint: At the beginning, 3 months and 9 months after entering this phase of study. Method of measurement: Colonoscopy.

Secondary Outcome Measures

Name	Time	Method
ipid 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.