Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
With
Children's Hospital of Philadelphia
Crohn's and Colitis Foundation
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant is capable of giving informed consent
Males or females 18-75 years of age
Normal kidney function (defined by normal serum creatinine \[male: \<1.27 mg/dL; female: \<1.03 mg/dL\])
Normal aspartate aminotransferase \[AST\] (\<41 U/L), alanine aminotransferase \[ALT\] (\<63 U/L), and alkaline phosphatase (\<126 U/L)
Active CD defined as HBI ≥ 7
CRP \> 5 mg/dL or hs-CRP \> 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) \> - - 350 mcg/g (within one month of enrollment)
Have been treated with one of the following therapies\*\* for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response \[LOR\] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab \*\*These medications must have been administered at standard, therapeutic dosages.
You may not be if
Known or suspected stricturing disease producing obstructive symptoms
Active Clostridium difficile infection
Unwillingness to provide informed consent
Allergy or intolerance to the medications used in this study
History of kidney disease
History of liver disease
Pregnant or lactating females
Baseline QTc interval on EKG \> 430 in males or \> 450 in females
Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
