NCT07273760

Brief 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. 1.Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease?
  2. 2.Is VedAryo® (Vedolizumab) safe in the treatment of Inflammatory Bowel Disease?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

November 25, 2025

Last Update Submit

December 9, 2025

Conditions

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

Keywords

vedolizumabIBDUlcerative ColitisCrohn's diseaseInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving Clinical Response at 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 Outcomes (2)

  • Safety Assessment During 52 Weeks

    Up to 52 weeks

  • Percentage of Participants Achieving Clinical Remission at Week 52

    Baseline, week 52

Study Arms (1)

Participants received VedAryo® (Vedolizumab)

Drug: Vedolizumab

Interventions

VedolizumabDRUG

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

Participants received VedAryo® (Vedolizumab)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Dr. Mohammad-Javad Kaviani Clinic

Shiraz, Fars, Iran

Location

Gilan Gastroenterology and Hepatology Subspecialty Clinic

Rasht, Gilan Province, Iran

Location

Dr. Ali Beheshti-Namdar Clinic

Mashhad, Razavi Khorasan Province, Iran

Location

Dr. Hassan Vossoughinia Clinic

Mashhad, Razavi Khorasan Province, Iran

Location

Dr. Hamid Asadzadeh Aghdaei Clinic

Tehran, Iran

Location

Dr. Mahtab Shabani Clinic

Tehran, Iran

Location

Dr. Naser Ebrahimi Daryani Clinic

Tehran, Iran

Location

Imam Khomeini Hospital

Tehran, Iran

Location

Mehr Specialty Clinic

Tehran, Iran

Location

Professor Shahram Agah Gastroenterology, Hepatology, and Endoscopy Subspecialty Clinic

Tehran, Iran

Location

Shariati Hospital

Tehran, Iran

Location

Taleghani Hospital

Tehran, Iran

Location

Related Publications (2)

  • Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.

    PMID: 23964932RESULT

  • Yarur A, Mantzaris GJ, Wang S, Adsul S, Kamble P, Cook E, Sajeev G, Guerin A, Bressler B. Stratified Patient Profiling for Vedolizumab Effectiveness in Crohn's Disease: Identifying Optimal Subgroups for Enhanced Treatment Response in the EVOLVE Study. Adv Ther. 2024 Jun;41(6):2324-2341. doi: 10.1007/s12325-024-02825-w. Epub 2024 Apr 24.

    PMID: 38658485RESULT

Related Links

MeSH Terms

Conditions

Colitis, UlcerativeCrohn DiseaseInflammatory Bowel Diseases

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
52 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 10, 2025

Study Start

July 16, 2023

Primary Completion

September 30, 2025

Study Completion

October 5, 2025

Last Updated

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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

Locations

IR(12)