A Phase 2 interventional study of Tofacitinib 10 mg in Pouchitis, Ileal Pouchitis and Ileal Pouch, sponsored by Cedars-Sinai Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Cedars-Sinai Medical Center · Phase 2, Interventional, and Treatment
A phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis
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.
50 studies on the registry are indexed under Pouchitis; 13 are open to participants now.
This study's enrollment of 6 is below the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Cedars-Sinai Medical Center is the lead sponsor of 455 studies on the registry; 108 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 49 (75%) have results posted.
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Exclusion Criteria:
Subjects with clinically significant laboratory abnormalities at study screening.
This arm will include subjects with chronic pouchitis and will receive tofactinib 10 mg twice daily for 8 weeks
Drug: Tofacitinib 10 mg
Subjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Seven patients were screened and 6 met the eligibility criteria. One patient was ineligible due to an endoscopic PDAI subscore of 1 on screening pouchoscopy. Study recruitment was terminated prematurely due to COVID-19 pandemic-related recruitment challenges.
| Milestone | Chronic Active Pouchitis |
|---|---|
| Started | 6 |
| Completed | 6 |
| Not completed | 0 |
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.
| Participants | Chronic Active Pouchitis |
|---|---|
| Number of Participants With Clinical Response/Remission | 4 |
The proportion of subjects with clinical remission at 8 weeks, defined as modified pouchitis disease activity index (mPDAI) \<5.
| Participants | Chronic Active Pouchitis |
|---|---|
| Number of Participants With Clinical Response | 4 |
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.
| Participants | Chronic Active Pouchitis |
|---|---|
| Number of Participants With Clinical Remission | 3 |
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.
| score on a scale | Chronic Active Pouchitis |
|---|---|
| Change in mPDAI Score | -4.5 (-8.33 to -4.34) |
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.
| score on a scale | Chronic Active Pouchitis |
|---|---|
| Change in mPDAI Clinical Sub-score | -1.7 (-2.33 to -1.34) |
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.
| score on a scale | Chronic Active Pouchitis |
|---|---|
| Change in mPDAI Endoscopic Sub-score | -2 (-6 to -1) |
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.
| score on a scale | Chronic Active Pouchitis |
|---|---|
| Change in IBD-related Quality of Life | 0.1 (0 to 0.3) |
Collected over Adverse Events were monitored from the beginning of the study (week 0) up to 12 weeks (4 weeks after the completion of the study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chronic Pouchitis | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) |
| Event | Chronic Pouchitis |
|---|---|
| SepsisGastrointestinal disorders | 1/6 |
| Pouchitis Flare/SMA (superior mesentery artery) syndromeGastrointestinal disorders | 1/6 |
| Severe Malnutrition/failure to thrive secondary to SMA syndromeMetabolism and nutrition disorders | 1/6 |
| worsening of superior mesenteric artery syndromeGastrointestinal disorders | 1/6 |
| Event | Chronic Pouchitis |
|---|---|
| Worsening of pouchitis disease symptomsGastrointestinal disorders | 1/6 |
| Flu-like symptomGeneral disorders | 1/6 |
| COVID-19 test positiveGeneral disorders | 1/6 |
| Age, Categorical(Participants) | Chronic Active Pouchitis |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Age, Continuous(Years) | Chronic Active Pouchitis |
|---|---|
| Median | 23.5 (19 to 53) |
| Sex: Female, Male(Participants) | Chronic Active Pouchitis |
|---|---|
| Female | 3 |
| Male | 3 |
| Race (NIH/OMB)(Participants) | Chronic Active Pouchitis |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 5 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Chronic Active Pouchitis |
|---|---|
| United States | 6 |
| Prior Biologic Use for Pouchitis(Participants) | Chronic Active Pouchitis |
|---|---|
| Count of participants | 6 |
| Indication for Colectomy(Participants) | Chronic Active Pouchitis |
|---|---|
| Active ulcerative colitis | 6 |
| Dysplasia/cancer | 0 |
| Concomitant Medications(Participants) | Chronic Active Pouchitis |
|---|---|
| On Antibiotics | 4 |
| On Corticosteroids | 1 |
| On Immunomodulators | 0 |
| Other | 1 |
3 further baseline measures are reported on the registry.
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This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tofacitinib