Ulcerative Colitis. Ulcerative colitis
Conditions
Interventions
Intervention group: Treated with Rhofanib® 10 mg twice daily for 8 weeks and 5 mg twice daily for one year (52 weeks).
Sponsors
Digestive Disease Research Institute of Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Be able to give informed consent. Known case of moderate to severe Ulcerative Colitis as Mayo score =6 or Sigmoidoscopy Sub Score =2 and expansion =2 15cm from Anal Verge with at least one of the followings: CRP= 2.87 mg/L or = 3 large ulcers in colonoscopy or = 10 aphthous ulcer or stool calprotectin = 250 mg/gr No clinical response or clinical remission (failed treatment) after ant TNF defined as: 1- Signs and symptoms of stable active disease despite taking more than or equal to 14 weeks of the following medication regimens 1-1)infliximab 5mg/kg IV at least 2 doses with 2 weeks interval 1-2) adalimumab 80 mg SC first dose then 40 mg SC with 2 weeks intervals 1-3) Recurrence of symptoms after initial recovery when the patient is on anti-TNF maintenance therapy 2- History of intolerance to at least one type of Anti-TNF drug, including injection-induced allergies, demyelination, infection, and congestive heart failure. Be able to use less than 30 mg per day prednisolone or 9mg per day budesonide, immunosuppressants (Azaram, 6MP, MTX) or Mesalazine and antibiotics.
Exclusion criteria
Exclusion criteria: Symptoms of infection such as abdominal abscess or Toxic Mega Colon during patient visits Surgery and removal of a large part of the intestine (complete or subtotal colectomy, history of more than 3 times surgery and resection of the small intestine or diagnosis of short bowel syndrome), symptomatic colonic stenosis, ostomy. Ileostomy, colostomy, well-known symptoms of small bowel stenosis. Use of Anti-TNF drugs 60 days before registration. Use of cyclosporine, Thalidomide or research drugs within 30 days prior to registration. Previously been treated with drugs such as Rituximab, Natalizumab Vedolizumab Chronic hepatitis B or C infection Clostridium difficile infection during the last 60 days Active or latent tuberculosis Do not have the results of TB diagnostic test. Amoebiasis trophozoite infection in fecal examination Immune deficiency (HIV infection or congenital immunodeficiency) Has received live vaccines in the last 30 days. Pregnancy or breastfeeding An unstable or uncontrolled medical disorder that requires hospitalization or major surgery at the initial visit A surgical procedure that required general anesthesia during the last 30 days Existence of colon dysplasia Any malignant cancer WBC less than 3000 lymphocyte less than 500 platelet less than 100000 or more than 1200000 ALT or AST greater than 3 times the maximum normal value ALP greater than 3 times the maximum normal value Serum Cr more than 2 times the maximum normal value Absence from all visits or non adherence to study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mayo score. Timepoint: During induction treatment at weeks 2, 4, 6 and 10 and then every 4 weeks until week 52. Method of measurement: The Mayo Score is a standard method for assessing the severity of ulcerative colitis in clinical trials and consists of 4 components, 2 of which are reported by the patient (including lower gastrointestinal bleeding and the number of defecation) and an evaluation by a physician and an endoscopic examination. Each component consists of a score of 3-0, the total score being calculated from 1-12 (a higher score indicates that the patient is more severe). Relative Mayo Clinic Score consists of the Mayo Clinic Score minus Sigmoidoscopy sub score in the range 0-9 with higher numbers indicates more severe disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Remission. Timepoint: Week 10 and 24. Method of measurement: Defined as 2 = Mayo Score in week 10.;Mucosal healing. Timepoint: Week 10 and 24. Method of measurement: Colonoscopy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Reza Sima
Digestive Disease Research Institute
Outcome results
None listed