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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants received VedAryo® (Vedolizumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab administered IV with a suggested dose of 300 mg at 0, 2, and 6 weeks and then once every 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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Primary care clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Mohammad-Javad Kaviani Clinic | Shiraz | Fars | Iran | |||
| Gilan Gastroenterology and Hepatology Subspecialty Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23964932 | Result | 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. | |
| 38658485 |
| Label | URL |
|---|---|
| Related Info | View source |
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Data produced in the present study are available upon reasonable request from the investigators.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
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| 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. | Baseline, week 52 |
| Rasht |
| Gilan Province |
| Iran |
| Dr. Ali Beheshti-Namdar Clinic | Mashhad | Razavi Khorasan Province | Iran |
| Dr. Hassan Vossoughinia Clinic | Mashhad | Razavi Khorasan Province | Iran |
| Dr. Hamid Asadzadeh Aghdaei Clinic | Tehran | Iran |
| Dr. Mahtab Shabani Clinic | Tehran | Iran |
| Dr. Naser Ebrahimi Daryani Clinic | Tehran | Iran |
| Imam Khomeini Hospital | Tehran | Iran |
| Mehr Specialty Clinic | Tehran | Iran |
| Professor Shahram Agah Gastroenterology, Hepatology, and Endoscopy Subspecialty Clinic | Tehran | Iran |
| Shariati Hospital | Tehran | Iran |
| Taleghani Hospital | Tehran | Iran |
| 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. |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |