VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation

AryoGen Pharmed

Status: Completed

Conditions: Inflammatory Bowel Disease (IBD); Ulcerative Colitis (UC); Crohn Disease (CD)

Treatments: Drug: Vedolizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT07273760

VDZ.ARY.HV.IV.02

Details and patient eligibility

About

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)

Full 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.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

150 participants in 1 patient group

Participants received VedAryo® (Vedolizumab)

Treatment:

Drug: Vedolizumab