A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Upadacitinib (Nupada® produced by NanoAlvand Co.) in pa-tients with inflammatory bowel diseases.
To evaluate the safety profile of Nupada® in real-world practice.
Design
Phase IV, Prospective, observational
Settings and conduct
This study will be conducted on 161 patients with inflammatory bowel disease (ulcerative colitis and Crohn’s disease) who are candidates for treatment with Nupada® over 24 weeks. During this period, patients with ulcerative colitis will have 5 visits (at baseline, week 4, week8, week 16, and week 24), and patients with Crohn’s disease will have 4 visits (at baseline, week 4, week 12, and week 24(. At each visit, participants will be evaluated and asked about the occurrence of adverse events after starting Nupada® by their physicians. Also, at each visit, the effectiveness of Nupada® will be evaluated with the partial Mayo score in patients with ulcerative colitis and with Harvey-Bradshaw index in patients with Crohn’s disease. Furthermore, the effectiveness of Nupada® will be assessed by the percentage of pa-tients achieving clinical response at week 24 based on the Mayo score in patients with ulcerative colitis and the Harvey-Bradshaw index in patients with Crohn’s disease.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Patients with ulcerative colitis or Crohn’s disease
2. Patients who are candidates to receive Upadacitinib treatment according to the in-vestigator’s opinion
3. Ability to comprehend and willingness to give consent for this study
Exclusion criteria
NA
Intervention groups
Tablets of Nupada® will be prescribed and ingested by patients with a dose and frequency based on the physician’s opinion.
Main outcome variables
Adverse events occurred during study until week 24 based on the physician’s assessment. Clinical re-sponse at week 24 based on changes in Mayo score in patients with ulcerative colitis and Harvey-Bradshaw in patients with Crohn’s disease com-pared to baseline.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150303021315N46
Registration date:2026-10-09, 1405/07/17
Registration timing:registered_while_recruiting
Last update:2026-10-09, 1405/07/17
Update count:0
Registration date
2026-10-09, 1405/07/17
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-02, 1405/07/10
Expected recruitment end date
2027-07-01, 1406/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Post-Marketing Surveillance Study to Evaluate the Safety and Effectiveness of Upadacitinib (Nupada® produced by NanoAlvand Co.) in pa-tients with inflammatory bowel diseases.
Public title
Study to evaluate safety and effectiveness of Upadacitinib (Nupada® produced by NanoAlvand Co.) in patients with inflammatory bowel diseas-es.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ulcerative colitis or Crohn’s disease
Patients who are candidates to receive Upadacitinib treatment according to the investigator’s opinion
Ability to comprehend and willingness to give con-sent for this study
Exclusion criteria:
NA
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
202
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
6th Floor, Building No. 2, University Headquarters, Shahid Beheshti University of Medical Sciences and Health Services, Arabi St., Chamran Highway, Tehran, Iran
To evaluate the safety of Upadacitinib (Nupada®, produced by NanoAlvand Co.) through the adverse events occurred during study based on physician assessment.
Timepoint
In every visit until week 24
Method of measurement
Adverse events occurred during the study based on physician assessment
Secondary outcomes
1
Description
Percentage of patients with clinical response* at week 24*Definition of Clinical Response based on Mayo Score in patients with ulcerative colitis: A decrease of at least three points in the patient's Mayo Score compared to the screening visit,ANDA decrease of at least 30% in the patient's Mayo Score compared to the screening visit,ANDThe Subscore related to Rectal Bleeding must de-crease by at least one point, or the score for this cri-terion must be 0 or 1.*Definition of Clinical Response based on Harvey-Bradshaw Index in patients with Crohn’s disease: A decrease of at least three points in the patient's Har-vey-Bradshaw Index compared to the screening vis-it.
Timepoint
Mayo score in patients with ulcerative colitis: Baseline, Week 4, Week 8, Week 16, Week 24Harvey-Bradshaw index in patients with Crohn’s disease:Baseline, Week 4, Week 12, Week 24
Method of measurement
Mayo score (for ulcerative colitis): Physician’s as-sessment and colonoscopyHarvey-Bradshaw index (for Crohn’s disease): Phy-sician’s assessment
Intervention groups
1
Description
Intervention group: Tablets of Nupada® (Upadacitinib produced by NanoAlvand Co.) will be prescribed and ingested by patients with a dose and frequency based on the physician’s opinion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Dr. Shabnam Shahrokh
Street address
Gastroenterology and Liver Diseases Research Center, Talaghani Hospital Courtyard, Arabi St., Yemen St., Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1678
Email
Shabnamshahrokh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
NanoAlvand Co.
Full name of responsible person
Dr.nima sepehri
Street address
Unit 52, 5th Floor, Owj Tower, No. 485, between 63rd and 65th Streets, Asadabadi St., Yousef Abad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1434964744
Phone
+98 21 9107 7339
Email
info@nanoalvand.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?