| CTRI Number |
CTRI/2025/03/082173 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess tofacitinib effects in Ulcerative colitis patient |
|
Scientific Title of Study
|
To assess the efficacy, tolerability and change in quality of life among Ulcerative colitis patients who are taking Tofacitinib: An Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Leo Angom Mani |
| Designation |
Junior Resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Gastroenterology office, 1st floor, Nehru Hospital,PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9560376336 |
| Fax |
|
| Email |
leoangom6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saroj Kant Sinha |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Gastroenterology Department, block F, Nehru Hospital,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209614 |
| Fax |
01722744401 |
| Email |
sarojksinha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saroj Kant Sinha |
| Designation |
Professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Gastroenterology Department, block F, room no 1, Nehru Hospital,PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209614 |
| Fax |
|
| Email |
sarojksinha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Gastroenterology Office, 1 st floor, Nehru Hospital, PGIMER, Sector 12, Chandigarh, India, 160012 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
Kairon Block- Administrative block,PGIMER, Sector 12, Chandigarh, India, 160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Leo Angom Mani |
Post Graduate Institute of Medical Education and Research |
Gastroenterology ward, room no 8, block F, 2nd Floor,Nehru Hospital, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
9560376336
leoangom6@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 Committe (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 |
| Intervention |
Tab Tofacitinib |
Tab Tofacitinib 20 mg Once Daily per orally for 1 months followed by Tab Tofacitinib 10 mg Once daily per orally for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patient diagnosed with Ulcerative colitis
2. Patients giving willful consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient taking steroid or other biological drugs
2. Pregnant and lactating women
3. Malignancy
4. Patients with Crohn’s disease, microscopic colitis, and celiac disease
5. Patients with uncertain diagnosis
6. Patient unwilling to participate in study
7. Myocardial infarction (within previous 3 months)/Heart failure
8. Use of combined hormonal contraceptives or hormone replacement therapy
9. Patient with uncontrolled diabetes, uncontrolled hypertension |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate mayo score, UCEIS and True love and Witt score before starting the treatment and after giving 1 month of induction followed by 3 months of maintenance dose of tofacitinib, then compare the both values. |
1 month of induction followed by 3 months of maintenance therapy with tab Tofacitinib. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(1) to measure any bleeding episodes- Hematochezia during the treatment period - 4 months from initiation of treatment
(2) Any hospital admission & duration of hospital stay during during the treatment period
(3) Patient Satisfactory score
(4) Incidences of adverse events- hyperlipidemia, Myocardial infarction, Respiratory tract infection |
(1) to measure any bleeding episodes- Hematochezia during the treatment period - 4 months from initiation of treatment
(2) Any hospital admission & duration of hospital stay during during the treatment period
(3) Patient Satisfactory score
(4) Incidences of adverse events- hyperlipidemia, Myocardial infarction, Respiratory tract infection |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [leoangom6@gmail.com].
- For how long will this data be available start date provided 11-06-2024 and end date provided 11-09-2028?
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
|
Ulcerative colitis was once considered to be a disease of the Western
world, but the incidence among Asian people is increasing. Topical mesalamine
and steroids are the main line of treatment for newly diagnosed Ulcerative
colitis. In severe disease activity
intravenous steroid, intravenous anti TNF alpha (infliximab/adalimumab) or
intravenous cyclosporin are used. In May 30, 2018, FDA approved
tofacitinib for the treatment of moderate to severely active ulcerative
colitis. Tofacitinib is also orally available and is cost-effective. As it is not a monoclonal antibody, it
is not antigenic. The
purpose of this observational study is to evaluate
the benefits, tolerability, efficacy and acceptance of tofacitinib in Indian
Population. This study will also help to unfold any
hinderance facing by the patient during its uses and assess the change in the quality
of life among Ulcerative colitis patients who are taking Tofacitinib.
|