Ulcerative ColitisTOCASUNCT05112263
Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis
A study testing Tofacitinib and Cyclosporine in people with Ulcerative Colitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Tofacitinib and Cyclosporine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2023to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria WITH Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by
- Day 3 non-response as per Oxford criteria (stool frequency of > 8/day, OR stool frequency between 3-8 with CRP > 45 mg/L PLUS
- Ongoing activity as defined by Partial Mayo Score of > 3 (rectal bleeding sub-score of >1)
- Decision to start second line therapy (within 5-7 days of starting intravenous steroids)
Who cannot join
- Age <18, Age > 65 years
- E1 disease (involvement distal to rectosigmoid junction only)
- Crohn's disease
- Contraindication to intravenous cyclosporine or oral tofacitinib
- Renal failure, uncontrolled hypertension, seizure disorder,and uncorrected hypomagnesemia (<1.5 mg/L)
- Previous thrombosis, or prothrombotic state, on oral contraceptive, history of herpes zoster, active TB, active hepatitis, past opportunistic infections, h/o diverticulitis, Age >50 plus at least one cardiac risk factor
Show all 12Show fewer
- Patient wants treatment with intravenous infliximab or wants surgery
- Underlying sepsis or active infection (Enteric infections, Clostridium difficile, active hepatitis B or C, Tuberculosis, zoster, CMV disease)
- Toxic megacolon, previous dysplasia or any indication of immediate surgery
- Known malignancy
- Pregnancy or Lactation
- Unwilling to provide consent or for follow-up
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study
This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids
- Conditions
- Ulcerative Colitis
- Being tested
- Tofacitinib, Cyclosporine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
For the tofacitinib the dose of 10 mg BD will be administered for 8 weeks (10 mg TDS for initial three days) and then reduced to 5 mg BD for the period of study
CyclosporineDrug
: Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks.Those who respond with intravenous cyclosporine will be shifted to oral cyclosporine 4 mg/kg for 12 weeks while the thiopurine dose is adjusted to the patient's weight
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks Receives: Drug: Cyclosporine |
| Group B | Experimental | Oral Tofacitinib 10 mg TDS for 3 days, and then 10 mg BD to complete 8 weeks followed by 5 mg BD till follow-up (14 weeks) Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure
- At Day 7 Absence of clinical response at day 7 (as defined by Partial Mayo of > 3)
II) By Day 98
- Relapse (Partial Mayo Score of 3 or more) between day 7 and day 98 requiring additional therapy
- Absence of steroid free remission at 14 weeks (Mayo < 2 with MES 1 or less)
- Need for colectomy, third line medical rescue or biologics or mortality
- Serious adverse effect needing interruption of treatment
Measured: 14 weeks
Secondary outcomes (6)
Clinical response
Partial Mayo <4
Measured: 7 days
Absence of steroid free remission
Mayo score of more than 2 with endoscopic sub-score of more than 1
Measured: day 98
Colectomy free survival
No need for colectomy
Measured: 98 days
Time to clinical response
Partial Mayo of 3 or less
Measured: 98 days
Endoscopic healing
Mayo endoscopic sub-score of 1 or less
Measured: Day 98
Serious adverse effects
requiring hospitalization, cessation of treatment and events like cardiovascular events, pulmonary embolism, venous thrombosis, any infection, malignancy, gastrointestinal perforation
Measured: 98 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jul 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Responsible party
- Principal investigator, Vishal Sharma, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Vishal Sharma, Principal investigator, PGIMER ChandigarhVineet Ahuja, Principal investigator, AIIMS Delhi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112263
- Sponsor's protocol ID
- IEC/2021/000641
- Acronym
- TOCASU
- Status last verified
- Mar 2023
- First submitted
- 26 Oct 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The anonymised participant data may be shared on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tofacitinib Versus Cyclosporine for Steroid Refractory Acute Severe Ulcerative Colitis: An Open Label Randomized Study
- ClinicalTrials.gov ID
- NCT05112263
- Acronym / sponsor ID
- TOCASU / IEC/2021/000641
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised trial plans to compare oral tofacitinib with intravenous cyclosporine in patients with acute severe ulcerative colitis who have failed to respond to intravenous steroids
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: CyclosporineGroup A: Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks |
| Group B | Experimental | Drug: TofacitinibOral Tofacitinib 10 mg TDS for 3 days, and then 10 mg BD to complete 8 weeks followed by 5 mg BD till follow-up (14 weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted with Acute severe ulcerative colitis as defined by Modified Truelove and Witts Criteria WITH Failure to respond to intravenous steroids (Hydrocortisone 100 mg IV QID OR IV Methylprednisolone 60 mg IV OD) as defined by
- Day 3 non-response as per Oxford criteria (stool frequency of > 8/day, OR stool frequency between 3-8 with CRP > 45 mg/L PLUS
- Ongoing activity as defined by Partial Mayo Score of > 3 (rectal bleeding sub-score of >1)
- Decision to start second line therapy (within 5-7 days of starting intravenous steroids)
Key exclusion criteria (12 listed)
- Age <18, Age > 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibFor the tofacitinib the dose of 10 mg BD will be administered for 8 weeks (10 mg TDS for initial three days) and then reduced to 5 mg BD for the period of study | Drug | Group B |
| Cyclosporine: Intravenous Cyclosporine 2 mg/kg continuous infusion for 5-7 days and then shifted to oral cyclosporine 4 mg/kg/day in two divided doses for 12 weeks.Those who respond with intravenous cyclosporine will be shifted to oral cyclosporine 4 mg/kg for 12 weeks while the thiopurine dose is adjusted to the patient's weight | Drug | Group A |
Primary outcome
Treatment failure
Time frame: 14 weeks
I) At Day 7 Absence of clinical response at day 7 (as defined by Partial Mayo of > 3) II) By Day 98 1. Relapse (Partial Mayo Score of 3 or more) between day 7 and day 98 requiring additional therapy 2. Absence of steroid free remission at 14 weeks (Mayo < 2 with MES 1 or less) 3. Need for colectomy, third line medical rescue or biologics or mortality 4. Serious adverse effect needing interruption of treatment
6 secondary outcomes
Clinical response
Time frame: 7 days
Absence of steroid free remission
Time frame: day 98
Colectomy free survival
Time frame: 98 days
Time to clinical response
Time frame: 98 days
Endoscopic healing
Time frame: Day 98
Serious adverse effects
Time frame: 98 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No. The anonymised participant data may be shared on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vishal Sharma principal investigator
PGIMER Chandigarh
Vineet Ahuja principal investigator
AIIMS Delhi
Questions about this trial
What is this clinical trial studying?
A study testing Tofacitinib and Cyclosporine in people with Ulcerative Colitis, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vishal Sharma (+917087008099, docvishalsharma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.