NCT07273760

VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation

A Prospective and Observational Study for Effectiveness and Safety Evaluation of VedAryo® (Vedolizumab) in Patients With Inflammatory Bowel Disease

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: AryoGen Pharmed Co. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The aim of this observational study is to evaluate Effectiveness and safety of VedAryo® (Vedolizumab) in male or female participants with clinical diagnosis of Inflammatory Bowel Disease. The main questions are aim to answer: 1. Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease? 2. Is VedAryo® (Vedolizumab) safe in the treatment of Inflammatory Bowel Disease? In this study, there is no comparison group. Participants received VedAryo® (Vedolizumab)

Detailed description

This research was conducted as a phase IV, post-marketing, observational cohort study, in which VedAryo® (Vedolizumab) was prescribed as part of routine clinical practice, and no study-related intervention was introduced. The study aimed to evaluate the real-world effectiveness and safety of VedAryo® in Iranian patients diagnosed with Inflammatory Bowel Disease (IBD). The primary objective was to assess the effectiveness of VedAryo® based on clinical response, measured using the Mayo Scoring Index for ulcerative colitis and the Harvey-Bradshaw Index for Crohn's disease during the observation period. The secondary objective focused on safety, including the incidence of adverse events (AEs) and serious adverse events (SAEs) recorded over the 52-week observational follow-up.

Conditions

• Ulcerative Colitis (UC)
• Crohn Disease (CD)
• Inflammatory Bowel Disease (IBD)

Interventions

Type	Name	Description
DRUG	Vedolizumab	Vedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks

Timeline

• Start date: 2023-07-16
• Primary completion: 2025-09-30
• Completion: 2025-10-05
• First posted: 2025-12-10
• Last updated: 2025-12-10

Locations

12 sites across 1 country: Iran