Ulcerative Colitis. Ulcerative colitis
Conditions
Interventions
Intervention 1: Intervention group: Vedolizumab (AryoGen) 300 mg, intravenous infusion, at day 0 and weeks 2 and 6, and if achieved clinical responese, at weeks 14 and 22. Intervention 2: Control grou
Sponsors
AryoGen Pharmed Company
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged 18–75 years (inclusive) at the time of signing the informed consent form Patients who have been diagnosed with ulcerative colitis based on ACG guideline for at least 6 months and have one of these conditions: a) No history of previous treatment with biologics b) History of anti-TNF therapy or failure Patients with moderate to severe active ulcerative colitis having Mayo score between 6 to 12 (Mayo endoscopic subscore of at least 2 based on colonoscopy) Ability to comprehend and willingness to sign the informed consent form for this study and adherence to the study protocol principles
Exclusion criteria
Exclusion criteria: Have a history of known serious allergies to any components of the formulation History or indication of extensive colonic surgery including subtotal or total colectomy Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine Diagnosis of indeterminate colitis, Crohn’s disease, or clinical findings suggestive of Crohn’s disease (i.e., fistula or granulomas) Evidence of abdominal abscess or history of toxic megacolon disease History, evidence of or treatment for Clostridium difficile infection within 8 weeks or other intestinal pathogens within 4 weeks prior to the study enrollment Having adenomatous colonic polyps Evidence of colonic mucosal dysplasia or its history Ulcerative Colitis limited to only the rectum (Proctitis) Previous treatment with Vedolizumab or Natalizumab Previous treatment with Rituximab within 1 year prior to the study enrollment Treatment failure with other biologics (Infliximab, Ustekinumab, Certolizumab pegol, and etc.) within 4 weeks prior to the study enrollment Previous treatment with Thalidomide, Cyclosporine, Tacrolimus or JAK inhibitors within 4 weeks prior to the study enrollment Previous treatment with natural or traditional medicines for gastrointestinal diseases within 2 weeks prior to the study enrollment Immunization with a live/attenuated vaccine less than 4 weeks before baseline visit or planning to receive these vaccines during the study Having hepatitis B, C or human immunodeficiency virus (HIV) infection Active or latent tuberculosis based on PPD >5 mm or positive IGRA test- The patients would not be enrolled in case of a positive result for either PPD or IGRA. - If any of these tests were unavailable, the result of one test would suffice for enrollment. - The patients who have received complete treatment for latent TB prior to enrolling in the study can Any identified congenital or acquired immunodeficiencies Active infection or history of hospitalization or receiving injectable antibiotics within 8 weeks, or oral antibiotics within 2 weeks prior to baseline visit (rather than antibiotics indicated for UC) Diagnosis of other autoimmune diseases Currently has a known malignancy or has a history of malignancy History of PML Abnormalities during screening in laboratory data including: Corrected hemoglobin 1200 × 109/L Aspartate Transaminase (AST) or Alanine Transaminase (ALT) = 100 IU/L Have had a substance abuse (drug or alcohol) problem within the previous 12 months prior to the study enrollment due to investigator’s opinion. Is pregnant, nursing, or planning a pregnancy (both men and women) during the study Treatment with any investigational agent in the past 4 weeks prior to baseline visit or passing less than five half-lives of the investigational agent (whichever is longer) Having any other condition which, in the opinion of the investigator, will make the subject inappropriate for enrolling the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical response at week 14Clinical response based on Mayo Score: - 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: Baseline, week 14. Method of measurement: Physician assessment and Endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving clinical remission at week 14 Clinical remission based on Mayo Score: Mayo Score of 2 points or lower, with no individual subscore exceeding 1 point. Timepoint: Baseline, week 14. Method of measurement: Physician assessment and Endoscopy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hamidreza Kafi
Orchid Pharmed Co.
Outcome results
None listed