N/A
N=13
Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis
Colitis, Ulcerative · Inflammatory Bowel Disease · IBD
Bottom Line
View on ClinicalTrials.gov: NCT02438410 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Number of Participants to be Colectomy Free at 3 Months — 6 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants to be Colectomy Free at 3 Months |
6 | — |
| PRIMARY Number of Participants With the Need for Colectomy Assessed by Biomarker Levels |
13 | — |
| SECONDARY Number of Participants to be Colectomy Free at 1 Month |
11 | — |
Summary
To assess if infliximab drug levels in subjects with Ulcerative Colitis predict risk of colectomy rate. Additionally, the investigators will estimate an optimal day 4 infliximab level based on the study results.
Eligibility Criteria
Inclusion Criteria
- Adults, ages 18-65 years
- Hospitalized, with a moderate -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. Their initiation or continuation remains at the discretion of the treating physician
Exclusion Criteria
- Ongoing or prior treatment with Infliximab or other anti TNF agents
- Ongoing or recent (with in 1 month) administration of rescue cyclosporine
- Fulminant colitis requiring emergent surgery or toxic megacolon
- 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
- Judgement of investigator
Data sourced from ClinicalTrials.gov (NCT02438410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.