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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With Clinical Response/Remission
Secondary study objectives
Change in IBD-related Quality of Life
Change in mPDAI Clinical Sub-score
Change in mPDAI Endoscopic Sub-score
+3 moreSide effects data
From 2015 Phase 2 trial • 208 Patients • NCT017866688%
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
Tofacitinib 2 mg BID
Placebo 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
509 Previous Clinical Trials
163,907 Total Patients Enrolled
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