VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation

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)

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Key information

Conditions

Ulcerative Colitis (UC) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease (IBD) Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Mohammad-Javad Kaviani Clinic, Shiraz, Fars, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients diagnosed with Inflammatory bowel disease, including Ulcerative Colitis and Crohn's disease
Patients with an indication of vedolizumab therapy
Ability to comprehend and willingness to sign the informed consent form for this study.

Treatment and study plan

Vedolizumab

Drug

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

Primary outcomes

Percentage of Participants Achieving Clinical Response at Week 52

Time frame: Baseline, week 52

Clinical response is defined as a decrease from baseline in HBI score of ≥3 points in CD participants and a decrease from baseline in Mayo Score of ≥3 points, ≥30%, and either a decrease from baseline in the rectal bleeding sub score of ≥ 1 or a rectal bleeding sub score of 0 or 1 in UC participants.

Secondary outcomes

Safety Assessment During 52 Weeks

Time frame: Up to 52 weeks

Safety assessment, including the incidence of AEs. All AEs are classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events are graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs is assessed according to International Council for Harmonisation (ICH-E2B) guidelines. The causality relation is assessed based on the World Health Organization (WHO) criteria.
Percentage of Participants Achieving Clinical Remission at Week 52

Time frame: Baseline, week 52

Clinical remission is defined as a HBI score of <5 points in CD participants and a Mayo Score of ≤2 points and no sub score of >1 in UC participants.

Sponsors and collaborators

Lead sponsor

AryoGen Pharmed Co.

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 10, 2025
Registry last updated: Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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