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CTRI Number  CTRI/2022/08/044613 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 10/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effect of Tofacitinib along with corticosteroids in patients with acute severe ulcerative colitis. 
Scientific Title of Study   A Prospective Placebo Controlled Randomized Clinical Study Of Tofacitinib As An Adjunct to corticosteroids in Acute Severe Ulcerative Colitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajit Sood 
Designation  Professor 
Affiliation  Dayanand medical college and hospital 
Address  Department of Gastroenterology, Dayanand Medical College and Hospital
Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815400718  
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ajit Sood 
Designation  Professor 
Affiliation  Dayanand medical college and hospital 
Address  Department of Gastroenterology, Dayanand Medical College and Hospital
Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  9815400718  
Fax    
Email  ajitsood10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manjeet Goyal 
Designation  DM Resident 
Affiliation  Dayanand medical college and hospital 
Address  Department of Gastroenterology, Dayanand Medical College and Hospital
Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India 
Phone  8285234620  
Fax    
Email  manjeetgoyal@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana 
 
Primary Sponsor  
Name  Dr Ajit Sood 
Address  Dayanand Medical College and Hospital, Ludhiana, Punjab 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajit Sood  Dayanand Medical College and Hospital  Department of Gastroenterology, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB 
9815400718

ajitsood10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K519||Ulcerative colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Patients with acute severe ulcerative colitis  Group 1 : Intravenous hydrocortisone (300 mg per day in three divided doses) plus Tofacitinib (10 mg thrice daily) for 7 days 
Comparator Agent  Patients with acute severe ulcerative colitis  Group 2 : Intravenous hydrocortisone (300 mg per day in three divided doses) plus Placebo (thrice daily) for 7 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients with acute severe ulcerative colitis (defined by Truelove
Witts Criteria)
2. Subject must be at least 18 years of age.
3. Subjects who are willing and able to comply with treatment plan,
laboratory tests, daily bowel movement diary call, and other study
procedures.
4. Subjects who are willing to provide a written informed consent. 
 
ExclusionCriteria 
Details  1. Presence of indeterminate colitis, microscopic colitis, ischemic
colitis, infectious colitis, or clinical findings suggestive of Crohn’s
Disease.
2. Subjects displaying clinical signs of fulminant colitis or toxic
megacolon
3. Subjects infected with human immunodeficiency virus (HIV) or
hepatitis B or C viruses
4. Subjects who have been vaccinated with live or attenuated vaccine
within 6 weeks of baseline or scheduled to receive these vaccines
during study period or within 6 weeks after last dose of study
medication

12
5. Subjects with malignancies or a history of malignancies, with the
exception of adequately treated or excised non-metastatic basal cell
or squamous cell cancer of the skin.
6. Subjects with current or recent history of severe, progressive, or
uncontrolled renal, hepatic, hematological, gastrointestinal,
metabolic, endocrine, pulmonary, cardiac, neurological disease.
7. Pregnant females 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The effectiveness of tofacitinib as adjunctive
therapy to intravenous hydrocortisone in patients with ASUC will be evaluated.
This will see the response of tofacitinib in achieving remission in patients with ASUC 
7 days Drug or placebo therapy
14th day Follow up
8 weeks Follow up 
 
Secondary Outcome  
Outcome  TimePoints 
The effectiveness of Tofacitinib in patients with ASUC. 
After 8 weeks Follow up 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/08/2022 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Suspended 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Ulcerative Collitis (UC) is a chronic immune-mediated inflammatory
condition of the large intestine that is frequently associated with
inflammation of the rectum but often extends proximally to involve
additional areas of the colon. The absence of rectal involvement has
been noted in fewer than 5% of adult patients with UC at diagnosis but
may be seen in up to one-third of pediatric-onset colitis. Determination of the extent and severity of disease is important to
select the appropriate treatment algorithm. Extent of the disease
should be characterized according to the Montreal classification as
proctitis (E1), left-sided colitis (E2), or extensive colitis (E3) (extension
proximal to the splenic flexure). [4,5] Commonly, severity of UC has been
classified according to the Truelove and Witts’ [6] criteria published in
1955. Mild colitis is defined as fewer than 4 bowel movements daily,
normal temperature, heart rate, hemoglobin (>11 g/dL), and ESR (<20
mm/hr). Severe disease is defined by bowel frequency greater than 6
times a day in conjunction with fever, tachycardia, anemia, or an
elevation in ESR. Tofacitinib, a JAK-STAT (Janus kinase-signal transducers and
activators of transcription) inhibitor and an anti-inflammatory drug, is a
new addition to the treatment modalities for UC. Janus kinases are
intracellular tyrosine kinases which mediate the signal transduction of
various cytokines involved in the inflammatory reactions in IBD, like IL-
6, IL-7, Il-10, IL-12, IFNα, IFNβ 2, 4, 7, 9 etc. The advantages of JAK-
STAT inhibitors over monoclonal antibodies include, the oral
administration, predictable pharmacokinetics with reduced plasma half-
life, rapid onset of action, quick clearance, lack of immunogenicity and
an intracellular target.
This is a placebo controlled randomized clinical study in subjects with
ASUC.
Patients with acute severe UC (defined as 6 or more stools with blood
and 1 or more of the following hemoglobin <10.5 g/dL, erythrocyte
sedimentation rate [ESR] >30 mm/hr or CRP > 30 mg/L, fever >37.8°C,
or tachycardia >90/min; the modified Truelove Witts criteria) and
fulfilling all other inclusion/exclusion criteria will be randomized. A
computer-generated randomization schedule will be used to assign
subjects to either of the two groups at a 1:1 allocation ratio.
Group 1 : Intravenous hydrocortisone (300 mg per day in three divided
doses) plus Tofacitinib (10 mg thrice daily) for 7 days
Group 2 : Intravenous hydrocortisone (300 mg per day in three divided
doses) plus Placebo (thrice daily) for 7 days.
Patients who fail to respond to treatment (defined as patients with >8
stools/day, or 3–8 stools/day with CRP >45 mg/L between days 3 and
5), necessitating initiation of salvage medical therapy
(biologics/cyclosporine) or colectomy would be started on appropriate
treatment at the discretion of the investigator.
Confirmed cases of IBD will be enrolled and the appropriate
investigations will be done. Daily stool frequency and questionnaire will
be filled. Patients will be followed-up every day for first 7 days followed
by on day 14 and after 8 weeks from the day of enrollment.
 
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