VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation

December 9, 2025 updated by: AryoGen Pharmed Co.

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran
      • Tehran, Iran
        • Dr. Hamid Asadzadeh Aghdaei Clinic
      • Tehran, Iran
        • Dr. Mahtab Shabani Clinic
      • Tehran, Iran
        • Dr. Naser Ebrahimi Daryani Clinic
      • Tehran, Iran
        • Imam Khomeini Hospital
      • Tehran, Iran
        • Mehr Specialty Clinic
      • Tehran, Iran
        • Professor Shahram Agah Gastroenterology, Hepatology, and Endoscopy Subspecialty Clinic
      • Tehran, Iran
        • Shariati Hospital
      • Tehran, Iran
        • Taleghani Hospital
    • Fars
      • Shiraz, Fars, Iran
        • Dr. Mohammad-Javad Kaviani Clinic
    • Gilan Province
      • Rasht, Gilan Province, Iran
        • Gilan Gastroenterology and Hepatology Subspecialty Clinic
    • Razavi Khorasan Province
      • Mashhad, Razavi Khorasan Province, Iran
        • Dr. Ali Beheshti-Namdar Clinic
      • Mashhad, Razavi Khorasan Province, Iran
        • Dr. Hassan Vossoughinia Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants received VedAryo® (Vedolizumab)
Drug: Vedolizumab
Vedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 52 weeks
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.
Baseline, week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AryoGen Pharmed Co.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

October 5, 2025

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VDZ.ARY.HV.IV.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data produced in the present study are available upon reasonable request from the investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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