Ulcerative Colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group: Infliximab (AryoGen Pharmed co., Iran), 5 mg/kg, intravenous infusion, at day 0 and weeks 2, 6, 14, and 22. Intervention 2: Control group: Remicade® (Infliximab, J
Sponsors
AryoGen Pharmed Company
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 18–65 years Moderate to severe active UC ICF signing
Exclusion criteria
Exclusion criteria: Active/latent TB serious allergies to the formulation Hepatitis B/C or HIV Recent gastrointestinal surgery indeterminate colitis or Crohn Receiving biologics, JAK inhibitors or ozanimod Tacrolimus and Cyclosporine within 4weeks Proctitis ASUC that requires hospitalization Severe fixed symptomatic stenosis of intestine Colonic obstruction or history of that within 6months Having or history of colonic mucosal dysplasia Adenomatous colonic polyps Malignancy within 5years History of Toxic megacolon C.diff within 60days CMV within 30days Receiving IV corticosteroids within 14days Herpes zoster within 8 weeks History of demyelinating diseases Diagnosis of other autoimmune-diseases HF class III/IV Abnormalities in laboratory data Receiving live/attenuated vaccine less than 4weeks or planning to receive them Pregnancy/ breastfeeding or planning to pregnancy in study Active infection or history of hospitalization or receiving IV antibiotics within 8weeks or oral within 2weeks Other disease or disorder which put the subject at risk Treatment with any investigational agent in the past 4 weeks or passing less than five half-lives of agent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical response based on MAYO score at week 8Clinical response: At least 3 points and 30% decrease from screening in the total MAYO Score; Decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. Timepoint: Screening, week 8. Method of measurement: Physician assessment and Endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical remission based on MAYO score at weeks 8 and 30Clinical remission: MAYO score of 2 points or lower, with no individual subscore exceeding 1 point. Timepoint: Screening, week 8, week 30. Method of measurement: Physician assessment and Endoscopy.;Percentage of patients achieving clinical response based on MAYO Score at week 30. Timepoint: Screening, week 30. Method of measurement: Physician assessment and Endoscopy.;Percentage of patients achieving mucosal healing at weeks 8 and 30Mucosal healing: Absolute subscore for Endoscopy of 0 or 1. Timepoint: Screening, week 8, week 30. Method of measurement: Endoscopy.;The changes of the IBDQ score at week 30 in comparison to week 0. Timepoint: Week 0, week 30. Method of measurement: IBDQ questionnaire.;Changes of Fecal calprotectin at week 30 in comparison to the screening. Timepoint: Screening, week 30. Method of measurement: Stool biochemistry test.;Percentage of patients with reduced dose of prednisolone at week 30 in comparison to screening. Timepoint: Screening, week 30. Method of measurement: Physician assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed