Trial · NCT04580277
Tofacitinib For Treatment Of Chronic Pouchitis
NCT04580277, Phase 2, Terminated, Cedars-Sinai Medical Center; results first posted 2024-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tofacitinib For Treatment Of Chronic Pouchitis. Trials, record NCT04580277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04580277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tofacitinib For Treatment Of Chronic Pouchitis
- NCT number
- NCT04580277
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Cedars-Sinai Medical Center
- Conditions
- Pouchitis, Ileal Pouchitis, Ileal Pouch
- Interventions
- Tofacitinib 10 mg
- First posted
- 2020-10-08
- Last updated
- 2024-04-04
- Results first posted
- 2024-04-04
- Limitations and caveats
Limitations of this study included a single center design, small sample size, and absence of a control arm. This study also lacked long-term follow-up data to assess durability of response to tofacitinib and its long-term safety in chronic pouchitis. This study also only included patients with chronic pouchitis and its findings may not be applicable to other chronic inflammatory pouch disorders. Study recruitment was terminated prematurely due to COVID-19 pandemic-related recruitment challenges.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinical Response/Remission | 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. |
| Secondary | Number of Participants With Clinical Response | 8 weeks | The proportion of subjects with clinical remission at 8 weeks, defined as modified pouchitis disease activity index (mPDAI) \<5. |
| Secondary | Number of Participants With Clinical Remission | 8 weeks | 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. |
| Secondary | Change in mPDAI Score | 8 weeks | 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. |
| Secondary | Change in mPDAI Clinical Sub-score | 8 weeks | 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. |
| Secondary | Change in mPDAI Endoscopic Sub-score | 8 weeks | 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. |
| Secondary | Change in IBD-related Quality of Life | 8 weeks | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Clinical Response/Remission | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Clinical Response | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Clinical Remission | 8 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in mPDAI Score | 8 weeks | score on a scale | MEDIAN | |
| SECONDARY | Change in mPDAI Clinical Sub-score | 8 weeks | score on a scale | MEDIAN | |
| SECONDARY | Change in mPDAI Endoscopic Sub-score | 8 weeks | score on a scale | MEDIAN | |
| SECONDARY | Change in IBD-related Quality of Life | 8 weeks | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Clinical Response/Remission | Chronic Active Pouchitis | 4 | Participants | ||
| Number of Participants With Clinical Response | Chronic Active Pouchitis | 4 | Participants | ||
| Number of Participants With Clinical Remission | Chronic Active Pouchitis | 3 | Participants | ||
| Change in mPDAI Score | Chronic Active Pouchitis | -4.5 | Inter-Quartile Range -8.33 to -4.34 | score on a scale | |
| Change in mPDAI Clinical Sub-score | Chronic Active Pouchitis | -1.7 | Inter-Quartile Range -2.33 to -1.34 | score on a scale | |
| Change in mPDAI Endoscopic Sub-score | Chronic Active Pouchitis | -2 | Inter-Quartile Range -6 to -1 | score on a scale | |
| Change in IBD-related Quality of Life | Chronic Active Pouchitis | 0.1 | Inter-Quartile Range 0 to 0.3 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chronic Active Pouchitis | 6 | |
| Overall Study | COMPLETED | Chronic Active Pouchitis | 6 | |
| Overall Study | NOT COMPLETED | Chronic Active Pouchitis | 0 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Worsening of pouchitis disease symptoms | Gastrointestinal disorders | Chronic Pouchitis | 1 | 6 | 1 |
| other | Flu-like symptom | General disorders | Chronic Pouchitis | 1 | 6 | 1 |
| other | COVID-19 test positive | General disorders | Chronic Pouchitis | 1 | 6 | 1 |
| serious | Sepsis | Gastrointestinal disorders | Chronic Pouchitis | 1 | 6 | 1 |
| serious | Pouchitis Flare/SMA (superior mesentery artery) syndrome | Gastrointestinal disorders | Chronic Pouchitis | 1 | 6 | 1 |
| serious | Severe Malnutrition/failure to thrive secondary to SMA syndrome | Metabolism and nutrition disorders | Chronic Pouchitis | 1 | 6 | 1 |
| serious | worsening of superior mesenteric artery syndrome | Gastrointestinal disorders | Chronic Pouchitis | 1 | 6 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chronic Pouchitis | 0 | 6 |
| Total, other adverse events | Chronic Pouchitis | 1 | 6 |
| Total, serious adverse events | Chronic Pouchitis | 1 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04580277
GET https://conductscience.org/api/trials/v1/NCT04580277/registered