PouchitisPhase 2NCT04580277
Tofacitinib For Treatment Of Chronic Pouchitis
A Phase 2 study testing Tofacitinib 10 mg in people with Pouchitis and Ileal Pouchitis, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pouchitis, Ileal Pouchitis, Ileal Pouch
- What is being tested?
- Tofacitinib 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 15 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ages 18 to 80
- Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.
- Subjects with pouchitis that is chronic, defined by a mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline study visit and a minimum endoscopic sub-score of 2 (outside the staple or suture line) with either (a) ≥ 3 recurrent episodes within 1 year prior to the screening treated with ≥2 weeks of antibiotic or other prescription therapy, (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline study visit
- Women of childbearing potential must have documentation of a negative pregnancy test at screening and must agree to use two highly effective methods of birth control during the study and for at least 1 month after completion of study drug dosing.
Who cannot join
- Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.
- Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.
- Subjects with prior exposure to tofacitinib.
- Subjects with a diverting stoma.
- Subjects with a prior history or risk factors for venous thromboembolism.
- Subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection.
Show all 12Show fewer
- Subjects with a history of latent or active tuberculosis.
- Subjects positive for hepatitis B virus (HBV) surface antigen, hepatitis B virus core antibody with a negative hepatitis B surface antibody or with detectable serum hepatitis B DNA.
- Female subjects who are pregnant or lactating.
- Female subjects of childbearing potential who are sexually active and do not agree to using two highly effective methods of contraception during the study period.
- Subjects with clinically significant laboratory abnormalities at study screening.
- Other eligibility criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Single Center Open-Label Prospective Study Of Oral Tofacitinib In Patients With Chronic Pouchitis
A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis
Read the detailed description
The proposed study is a phase 2, open-label study of tofactinib in treatment of patients with chronic pouchitis. Subjects with chronic active pouchitis will be screened and recruited if they meet eligibility criteria. Eligible subjects will undergo baseline clinical evaluation, laboratory testing and a pouch endoscopy. They will then receive oral tofacitinib 10 mg twice daily for 8 weeks. Clinical and laboratory data will be collected at week 4 and week 8, and all subjects will undergo a end of treatment pouch endoscopy at 8 weeks. Clinical, laboratory and endoscopic data at 8 weeks will be compared to the baseline data to evaluate study outcomes.
- Conditions
- Pouchitis, Ileal Pouchitis, Ileal Pouch
- Being tested
- Tofacitinib 10 mg
- Keywords
- chronic pouchitis, tofacitinib, antibiotic-refractory pouchitis, antibiotic-dependent pouchitis
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 10 mgDrug
Subjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chronic pouchitis | Experimental | This arm will include subjects with chronic pouchitis and will receive tofactinib 10 mg twice daily for 8 weeks Receives: Drug: Tofacitinib 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Response/Remission
The proportion of subjects with clinical response at 8 weeks, defined as ≥2-point decrease in modified pouchitis disease activity index (mPDAI) with at least 1-point decrease in endoscopic subscore compared to the baseline.The mPDAI is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
Measured: 8 weeks
Secondary outcomes (6)
Number of Participants With Clinical Response
The proportion of subjects with clinical remission at 8 weeks, defined as modified pouchitis disease activity index (mPDAI) <5.
Measured: 8 weeks
Number of Participants With Clinical Remission
The proportion of subjects with clinical remission at 8 weeks, defined as a modified pouch disease activity index (mPDAI) score of <5 with a ≥2-point decrease from the baseline mPDAI score. The mPDAI is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
Measured: 8 weeks
Change in mPDAI Score
change in median mPDAI score at 8 weeks compared to baseline. The mPDAI (modified pouchitis disease activity index) is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
Measured: 8 weeks
Change in mPDAI Clinical Sub-score
change in median clinical mPDAI sub-score at 8 weeks compared to baseline. The mPDAI (modified pouchitis disease activity index) is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
Measured: 8 weeks
Change in mPDAI Endoscopic Sub-score
change in median endoscopic mPDAI sub-score at 8 weeks compared to baseline. The mPDAI (modified pouchitis disease activity index) is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
Measured: 8 weeks
Change in IBD-related Quality of Life
CGQL is a quality of life questionnaire used in inflammatory bowel diseases that incorporates three domains - quality of life, quality of health and energy level. Each domain is scored from 0 (worst) to 10 (best)and a total score is calculated by dividing the cumulative score by 30. The CGQL score can range from 0 to 1. Change in quality of life as measured by the Cleveland Global Quality of Life score (CGQL) at 8 weeks compared to baseline.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start25 Jan 2021
- Primary completion1 Dec 2022
- Study completion15 May 2023
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PouchitisStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gil Melmed, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580277
- Sponsor's protocol ID
- STUDY00000693
- Status last verified
- Mar 2024
- First submitted
- 2 Oct 2020
- Last updated
- 4 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Open-Label Prospective Study Of Oral Tofacitinib In Patients With Chronic Pouchitis
- ClinicalTrials.gov ID
- NCT04580277
- Acronym / sponsor ID
- STUDY00000693
- Conditions
- Pouchitis, Ileal Pouchitis, Ileal Pouch
- Keywords
- chronic pouchitis, tofacitinib, antibiotic-refractory pouchitis, antibiotic-dependent pouchitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis
Detailed description
The proposed study is a phase 2, open-label study of tofactinib in treatment of patients with chronic pouchitis. Subjects with chronic active pouchitis will be screened and recruited if they meet eligibility criteria. Eligible subjects will undergo baseline clinical evaluation, laboratory testing and a pouch endoscopy. They will then receive oral tofacitinib 10 mg twice daily for 8 weeks. Clinical and laboratory data will be collected at week 4 and week 8, and all subjects will undergo a end of treatment pouch endoscopy at 8 weeks. Clinical, laboratory and endoscopic data at 8 weeks will be compared to the baseline data to evaluate study outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pouchitis | Experimental | Drug: Tofacitinib 10 mgThis arm will include subjects with chronic pouchitis and will receive tofactinib 10 mg twice daily for 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects ages 18 to 80
- Subjects with a history of proctocolectomy with ileal pouch anal anastomosis (IPAA) for UC at least 6 months prior to screening.
- Subjects with pouchitis that is chronic, defined by a mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline study visit and a minimum endoscopic sub-score of 2 (outside the staple or suture line) with either (a) ≥ 3 recurrent episodes within 1 year prior to the screening treated with ≥2 weeks of antibiotic or other prescription therapy, (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline study visit
- Women of childbearing potential must have documentation of a negative pregnancy test at screening and must agree to use two highly effective methods of birth control during the study and for at least 1 month after completion of study drug dosing.
Key exclusion criteria (12 listed)
- Subjects with IPAA surgery done for Crohn's disease (CD) or familial adenomatous polyposis (FAP) indications.
- Subjects with primary CD of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch.
- Subjects with prior exposure to tofacitinib.
- Subjects with a diverting stoma.
- Subjects with a prior history or risk factors for venous thromboembolism.
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 |
|---|---|---|
| Tofacitinib 10 mgSubjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks | Drug | Chronic pouchitis |
Primary outcome
Number of Participants With Clinical Response/Remission
Time frame: 8 weeks
The proportion of subjects with clinical response at 8 weeks, defined as ≥2-point decrease in modified pouchitis disease activity index (mPDAI) with at least 1-point decrease in endoscopic subscore compared to the baseline.The mPDAI is a 0- 18 point scale of pouchitis disease severity, with higher scores corresponding to worse disease severity.
6 secondary outcomes
Number of Participants With Clinical Response
Time frame: 8 weeks
Number of Participants With Clinical Remission
Time frame: 8 weeks
Change in mPDAI Score
Time frame: 8 weeks
Change in mPDAI Clinical Sub-score
Time frame: 8 weeks
Change in mPDAI Endoscopic Sub-score
Time frame: 8 weeks
Change in IBD-related Quality of Life
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tofacitinib 10 mg in people with Pouchitis and Ileal Pouchitis, run by Cedars-Sinai Medical Center at 1 site in United States.
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: stopped early, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Response/Remission (time frame: 8 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 4 Apr 2024.