| CTRI Number |
CTRI/2023/09/057448 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
30/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effectiveness of tofacitinib in moderate to severe ulcerative colitis compared to steroid |
|
Scientific Title of Study
|
To study the effectiveness of tofacitinib as a first line therapy for treatment of moderate to severe ulcerative colitis and compare it with prednisolone. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shankar Roy |
| Designation |
senior resident |
| Affiliation |
pgimer |
| Address |
Department of gastroenterology , PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9508522066 |
| Fax |
|
| Email |
dr.shankar.ghy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saroj Kant Sinha |
| Designation |
Professor |
| Affiliation |
Department of gastroenterology, Post graduate institute of Medical Education and Research (PGIMER) |
| Address |
Department of gastroenterology , PGIMER Chandigarh 160012
Department of gastroenterology , Post graduate institute of Medical Education and Research (PGIMER) Chandigarh 160012
CHANDIGARH
160012
India |
| Phone |
09914209614 |
| Fax |
|
| Email |
sarojksinha@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shankar Roy |
| Designation |
senior resident |
| Affiliation |
Department of gastroenterology, Post graduate institute of Medical Education and Research (PGIMER) |
| Address |
Department of gastroenterology , PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9508522066 |
| Fax |
|
| Email |
dr.shankar.ghy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Depatrment of gastroenterology (Department of gastroenterology , Post graduate institute of Medical Education and Research (PGIMER) chandigarh |
|
|
Primary Sponsor
|
| Name |
Shankar Roy |
| Address |
Department of gastroenterology , PGIMER Chandigarh 160012 |
| Type of Sponsor |
Other [self] |
|
|
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 Shankar Roy |
Department of gastroenterology, Post graduate institute of Medical Education and Research (PGIMER) |
SR room, Department of gastroenterology, level 2, F block , PGIMER Chandigarh 160012
Chandigarh
CHANDIGARH |
09508522066
dr.shankar.ghy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Medical Education and Research INSTITUATIONAL ETHICS COMMITTEE |
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 |
prednisolone |
prednisolone 40 mg od to be tapered after 1 month (total duration 3 months ) |
| Intervention |
tofacitinib |
tofacitinib 10 mg bd till remission , followed by 5 mg BD (a total duration of treatment 3 month) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed cases of ulcerative colitis |
|
| ExclusionCriteria |
| Details |
ulcerative proctitis, severe commorbidity, c. difficile infection, toxic mega colon, any coagulopathy or hypercoaguable condition, thrombosis, pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the remission rate in both steroid and tofacitinib group |
at 4th week, 8th week and 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the safety profile and adverse events of the individual drugs |
3 months |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
15/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [dr.shankar.ghy@gmail.com].
- For how long will this data be available start date provided 02-08-2023 and end date provided 02-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
To study the effectiveness of tofacitinib as a first line therapy for treatment of moderate to severe ulcerative colitis and compare it with prednisolone. In recent clinical trials tofacitinib has been proven superior to placebo in moderate to severe UC for clinical remission and mucosal healing . The efficacy of Tofacitinib has not been directly compared against steroids. Alternative first line therapy to steroids for induction in patients with contraindication for steroids is also needed to be studied. So we planned this study to compare the efficacy of Tofacitinib against steroids for clinical remission and mucosal healing in patients having moderate to severe UC already on 5-ASA. |