A Study of the Relationship Between Infliximab Levels and the Rate of Colectomies in Patients who have Ulcerative Colitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-005723
- La Crosse, Wisconsin: 14-005723
NCT ID: NCT02438410
Sponsor Protocol Number: 14-005723
About this study
The purpose of this study is to assess if infliximab drug levels in patients who have Ulcerative Colitis predict the risk of needing a colectomy. Additionally, the investigators will estimate an optimal day 4 infliximab level based on the study results.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Adults, 18 years and older
- Hospitalized, with a moderate to severe flare based on the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Mayo score of equal or greater than 6)
- Treatment naïve to anti TNF agents
- Initiation of infliximab, with or without immunomodulator such as azathioprine
- Ongoing use of immunomodulators such as azathioprine or 6MP is acceptable and remains at the discretion of the treating physician
Exclusion Criteria
- Ongoing or prior treatment with Infliximab or other anti TNF agents
- Concomitant immunomodulator therapy is acceptable if on a stable dosing for atleast 4 weeks
- Current medications may be continued at the discretion of the treating physician
- Fulminant colitis or toxic megacolon requiring emergent surgery
- Pregnancy
- Infectious colitis, for example Clostridium difficile or CMV (cytomegalovirus) colitis
- Active infection or abscess
- Untreated latent or active tuberculosis (TB)
- Those with latent TB who are currently undergoing treatment can be included
- Please refer to appendix 1 for more information on specific inclusion and exclusion criteria related to TB testing
- Refer to 1.4.2 of appendix 1 for TB screening questions
- Active malignancy
- Active or history of Congestive Heart failure (CHF) or those who have received treatment for CHF
- Active or history of Multiple Sclerosis (MS), or those who have received treatment for MS
- Prisoners, institutionalized individuals, and individuals who are not capable of giving informed consent
- Other criteria that is the judgement of the investigator
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available