VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-16

Study Completion Date

2025-10-05

Brief Summary

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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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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants received VedAryo® (Vedolizumab)

Vedolizumab

Intervention Type DRUG

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

Interventions

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Vedolizumab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No