Ulcerative Colitis (UC)NCT07273760
VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation
An observational study of Ulcerative Colitis (UC) and Crohn Disease (CD), run by AryoGen Pharmed Co. at 12 sites in Iran.
Trial 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. Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease? 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulcerative Colitis (UC), Crohn Disease (CD), Inflammatory Bowel Disease (IBD)
- What is being tested?
- Vedolizumab
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 12 sitesIran
- Study dates
- 16 Jul 2023to 5 Oct 2025
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Iran12 sites
Dr. Ali Beheshti-Namdar Clinic
Mashhad, Razavi Khorasan Province
Dr. Hassan Vossoughinia Clinic
Mashhad, Razavi Khorasan Province
Gilan Gastroenterology and Hepatology Subspecialty Clinic
Rasht, Gilan Province
Dr. Mohammad-Javad Kaviani Clinic
Shiraz, Fars
Dr. Hamid Asadzadeh Aghdaei Clinic
Tehran
Dr. Mahtab Shabani Clinic
Tehran
Dr. Naser Ebrahimi Daryani Clinic
Tehran
Imam Khomeini Hospital
Tehran
Mehr Specialty Clinic
Tehran
Professor Shahram Agah Gastroenterology, Hepatology, and Endoscopy Subspecialty Clinic
Tehran
Shariati Hospital
Tehran
Taleghani Hospital
Tehran
About this study
Official title: 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:
- Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease?
- Is VedAryo® (Vedolizumab) safe in the treatment of Inflammatory Bowel Disease?
In this study, there is no comparison group. Participants received VedAryo® (Vedolizumab)
Read the 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.
- Being tested
- Vedolizumab
- Keywords
- vedolizumab, IBD, Ulcerative Colitis, Crohn's disease, Inflammatory Bowel Disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
Vedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Participants received VedAryo® (Vedolizumab) | Not described Receives: Drug: Vedolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 52
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start16 Jul 2023
- Primary completion30 Sep 2025
- Study completion5 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- AryoGen Pharmed Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273760
- Sponsor's protocol ID
- VDZ.ARY.HV.IV.02
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data produced in the present study are available upon reasonable request from the investigators.
Publications
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.
PubMed 23964932Yarur 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.
PubMed 38658485
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective and Observational Study for Effectiveness and Safety Evaluation of VedAryo® (Vedolizumab) in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT07273760
- Acronym / sponsor ID
- VDZ.ARY.HV.IV.02
- Keywords
- vedolizumab, IBD, Ulcerative Colitis, Crohn's disease, Inflammatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AryoGen Pharmed Co.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 5 Oct 2025 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is VedAryo® (Vedolizumab) effective in the treatment of Inflammatory Bowel Disease?
- Is VedAryo® (Vedolizumab) safe in the treatment of Inflammatory Bowel Disease?
In this study, there is no comparison group. Participants received VedAryo® (Vedolizumab)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants received VedAryo® (Vedolizumab) | – | Drug: Vedolizumab |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VedolizumabVedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks | Drug | Participants received VedAryo® (Vedolizumab) |
Primary outcome
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.
2 secondary outcomes
Safety Assessment During 52 Weeks
Time frame: Up to 52 weeks
Percentage of Participants Achieving Clinical Remission at Week 52
Time frame: Baseline, week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication: PubMed 23964932Feagan 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.
- Results publication: PubMed 38658485Yarur 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data produced in the present study are available upon reasonable request from the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and Crohn Disease (CD), run by AryoGen Pharmed Co. at 12 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Clinical Response at Week 52 (time frame: Baseline, week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07273760, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.