An observational study in Ulcerative Colitis (UC), Crohn Disease (CD) and Inflammatory Bowel Disease (IBD), sponsored by AryoGen Pharmed Co.. Completed at 12 sites in Iran. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by AryoGen Pharmed Co. · Observational
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:
In this study, there is no comparison group. Participants received VedAryo® (Vedolizumab)
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 150 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →AryoGen Pharmed Co. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Primary care clinic
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Vedolizumab
Vedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks
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.
Time frame: Baseline, week 52
Safety Assessment During 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.
Time frame: Up to 52 weeks
Percentage of Participants Achieving Clinical Remission at 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.
Time frame: Baseline, week 52
Plan to share: No — Data produced in the present study are available upon reasonable request from the investigators.
Ran from Jul 2023 to primary completion in Sep 2025, 26 months.
Of 83 industry-sponsored observational studies under Colitis, Ulcerative, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 72. This study's 26 months is below that.
Counting every sponsor, half of 271 studies reached it within 47 months; a quarter within 29 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AryoGen Pharmed Co.