| CTRI Number |
CTRI/2025/11/097363 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the efficacy of Tofacitinib versus Tofacitinib and Budesonide MMX in Ulcerative Colitis |
|
Scientific Title of Study
|
A randomised controlled trial to compare the efficacy of Tofacitinib versus Tofacitinib and Budesonide MMX for induction of clinical remission in moderate to severe Ulcerative Colitis |
| 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 Sayan Mazumder |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9674683473 |
| Fax |
|
| Email |
sayanm38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Saroj Kant Sinha |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology, Level 1, F Block, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209614 |
| Fax |
|
| Email |
sarojksinha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Saroj Kant Sinha |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Department of Gastroenterology, Level 1, F Block, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209614 |
| Fax |
|
| Email |
sarojksinha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Department of Internal Medicine, Nehru Hospital, Level 4, F Block, Sector 12, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Postgraduate Institute of Medical Education and Research, Sector 12, Chandigarh, 160012, India |
| 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 |
| Sayan Mazumder |
Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh |
Department of Internal Medicine, Level 4, F Block, Nehru Hospital, Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12
Chandigarh
CHANDIGARH |
9674683473
sayanm38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh, Institutional Ethics Committee (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tofacitinib |
Patients will receive only oral Tofacitinib 10 mg twice daily
for 12 weeks. Oral 5-ASA will be continued as per the standard treatment protocol. Response will be assessed at 4 weeks and 12 weeks. |
| Intervention |
Tofacitinib and Budesonide MMX |
Patients will receive oral Tofacitinib 10 mg twice daily for 12 weeks along with oral Budesonide MMX 9 mg once daily for a duration of 8 weeks. Oral 5-ASA will be continued as per the standard treatment protocol. Response will be assessed at 4 weeks and 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged more than 18 years with moderate to severe ulcerative colitis, diagnosed by clinical, endoscopic and histologic criteria. |
|
| ExclusionCriteria |
| Details |
1. Patients in remission,
2. Patients with ASUC defined as per the Truelove and Witt’s Criteria
3. Patients with disease limited to 15 cm from anal verge (proctitis only)
4. Patients with toxic megacolon
5. Patients with any serious infection, defined as any infection that requires hospitalization
or change in the treatment plan
6. Patients with Indeterminate colitis or Crohn’s disease
7. Patients with prior history of exposure to tofacitinib
8. Patients with prior use of steroids in the last 3 months
9. Lactating and pregnant females
10. Patients with suspected or proven malignancy
11. Patients with dyslipidemia precluding the use of tofacitinib
12. Patients with severe comorbidities
13. Patients with diagnosed case of liver cirrhosis
14. Patients with latent tuberculosis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical remission |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Mucosal healing
2) Clinical response
3) Rate of infection
4) Rate of cardiovascular events |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sayanm38@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2035?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an open label, parallel group, randomised controlled trial to be conducted in India’s tertiary care centre, PGIMER, Chandigarh. This study evaluates the combined effectiveness of tofacitinib and budesonide MMX for the treatment of moderate to severe ulcerative colitis and compare it with tofacitinib.
|