| CTRI Number |
CTRI/2026/03/106766 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
15/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A real life experience about the effectiveness of Upadacitinib and its side effects profile in moderate to severe crohns disease patient who didnot respond or are intolerant to conventional therapy or biologics therapy from a single centre |
|
Scientific Title of Study
|
Upadacitinib in moderate to severe crohns disease who have failed or are intolerant to conventional therapy or biologics therapy: a real world experience from a single tertiary centre |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumeet Chatterjee |
| Designation |
post doctoral trainee |
| Affiliation |
IPGMER, Kolkata |
| Address |
gastroenterology office, dept of medical gastroenterology, 4th floor, SDLD building, IPGMER, Kolkata, 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9838545106 |
| Fax |
|
| Email |
sumitchatterjeee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajib sarkar |
| Designation |
professor |
| Affiliation |
IPGMER, Kolkata |
| Address |
Department of gastroenterology, 4th floor, Ronald Ross building, IPGMER, Kolkata, 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9477371103 |
| Fax |
|
| Email |
drrajibsarkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeet chatterjee |
| Designation |
Post doctoral trainee |
| Affiliation |
IPGMER, kolkata |
| Address |
gastroenterology Office, Dept of medical Gastroenterology, 4th floor, Ronal Ross building, IPGMER, Kolkata, 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9838545106 |
| Fax |
|
| Email |
sumitchatterjeee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGMER, Kolkata |
| Address |
244, AJC Bose Road, Kolkata, 700020 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumeet chatterjee |
IPGMER hosiptal, kolkata |
IBD Clinic, new opd building, Dept of gastroenterology
Kolkata
WEST BENGAL |
9838545106
sumitchatterjeee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K509||Crohns disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
male and female with confirmed diagnosis of crohns disease. with inadequate response or intolerant to one or more conventional therapy |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Achievement of clinical remissionas as per CDAI |
Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| acheivement of clinical response as per CDAI |
week 12 |
| maintenance of clinical remission/ reponse |
6 months |
| acheivement of clinical remission as per PRO |
12 weeks and 6 months |
Discontinuation of corticosteroid use for CD per CDAI ( subjects
taking corticosteroids for CD at Baseline) |
week 12 |
Resolution of draining fistula (subjects with draining fistulas at
Baseline |
week 24 |
t least 50% decrease from Baseline in the number of days with very soft or
liquid stools (Type 6 or 7, per Bristol Stool Chart) during the last 7 days at
or 50% decrease in baseline in the pain score |
week 12 and 6 months |
| High sensitivity C-reactive protein (hs-CRP) |
week 12 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we will acquire the real-world data on the safety and efficacy of Upadacitinib in the management of Crohn’s disease at a single tertiary care center at IPGMER & SSKM Hospital. We will evaluate the clinical response of CD patients to Upadacitinib who are refractory/intolerant to conventional or biological therapy in a real-world setting. We will also evaluate the safety and tolerability of Upadacitinib in CD patients. We will also identify the baseline predictors for therapeutic response to Upadacitinib. Appropriate statistical analysis shall be applied. After applying proper inclusion and exclusion criteria, we shall enroll subjects in our study. Duration of enrollment of study will be till May month of 2027.
|