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Janus Kinase (JAK) Inhibitor

Tofacitinib 10 mg for Pouchitis

Phase 2
Waitlist Available
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will test whether tofacitinib is effective in treating chronic pouchitis, a form of inflammatory bowel disease.

Eligible Conditions
  • Pouchitis
  • Ileal Pouchitis
  • Ileal Pouch

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinical Response/Remission
Secondary outcome measures
Change in IBD-related Quality of Life
Change in mPDAI Clinical Sub-score
Change in mPDAI Endoscopic Sub-score
+3 more

Side effects data

From 2015 Phase 2 trial • 208 Patients • NCT01786668
8%
Upper respiratory tract infection
8%
Nasopharyngitis
6%
Abdominal pain upper
6%
Vulvovaginal mycotic infection
4%
Mouth ulceration
4%
Headache
4%
Diarrhoea
3%
Balanoposthitis
2%
Rash
2%
Arthralgia
2%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo BID
Tofacitinib 2 mg BID
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chronic pouchitisExperimental Treatment1 Intervention
This arm will include subjects with chronic pouchitis and will receive tofactinib 10 mg twice daily for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib 10 mg
2013
Completed Phase 3
~500

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
499 Previous Clinical Trials
164,851 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are authorized to take part in this medical research?

"Affirmative. According to the information held on clinicaltrials.gov, this experiment is currently recruiting volunteers. The initial posting was made on January 25th 2021 and it was last updated in May 30 2022 - 13 enrollees are being sought at a single medical centre."

Answered by AI

To which groups of people is this clinical research available?

"This test is enrolling 13 individuals with pouchitis, aged between 18 and 80. To be accepted into the study, candidates must meet several criteria: females of childbearing age need to undertake a pregnancy test and agree to use two forms of birth control while on medication; males or females within the given age range; history of proctocolectomy surgery 6 months prior to screening; chronic pouchitis as measured by mPDAI score ≥5 assessed three days before baseline visit with minimum endoscopic sub-score of 2 (outside staple or suture line); either 3 recurrent episodes in 1 year requiring antibiotic/prescription therapy, OR"

Answered by AI

What effects have been observed when administering Tofacitinib 10 mg?

"Tofacitinib 10 mg can be employed to manage juvenile arthritis, as well as conditions that are resistant or intolerant to methotrexate, and those with inadequate response to conventional treatments."

Answered by AI

Does this experiment include senior citizens as participants?

"The study has outlined that individuals who wish to join must be between 18 and 80 years old. Additionally, we have 5 studies for people under the age of majority and 38 trials recruiting elderly patients over 65."

Answered by AI

Are there any vacancies left for participants in this research?

"Affirmative, this clinical trial is recruiting participants. The listing on clinicialtrials.gov was initially posted January 25th 2021 and has recently been edited May 30th 2022. 13 patients are needed to be recruited at one site."

Answered by AI

How hazardous is the utilization of Tofacitinib 10 mg to those that administer it?

"Due to the Phase 2 nature of this clinical trial, our team assessed Tofacitinib 10 mg's safety as a score of two; that is, we have some data attesting its security but no evidence confirming efficacy."

Answered by AI

Has Tofacitinib 10 mg been tested in other medical experiments?

"At this time, 34 clinical trials have been organized to research the efficacy of Tofacitinib 10 mg. Of these studies, 7 are currently in Phase 3. While Shanghai is obversly a major site for said investigations, 662 other locations around the world are conducting related experiments too."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tofacitinib For Treatment Of Chronic Pouchitis
Gil Melmed 2021. "Tofacitinib For Treatment Of Chronic Pouchitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04580277.
~1 spots leftby Apr 2025
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