Early Serum Infliximab Levels in Severe Ulcerative Colitis.
Completed · Phase 1
Conditions studied: Ulcerative Colitis (UC), Inflammatory Bowel Disease
In brief
The aim of this study is to a.) evaluate whether early serum infliximab levels are predictive of avoidance of colectomy, b) evaluate whether serum albumin levels correlate with serum infliximab levels, and c) evaluate whether serum tumor necrosis factor levels are inversely correlated with serum infliximab levels. In patients hospitalized for severe ulcerative colitis and treated with high-dose infliximab, we predict that early serum infliximab levels (24, 48, and 72 hour) will be positively associated with clinical response and avoidance of colectomy.
Key facts
- Study ID
- NCT01971814
- Run by
- University of California, San Francisco
- People needed
- 11
- Starts
- 2013-11-01
- Expected to finish
- 2015-01-01
- Last updated by the study team
- 2015-05-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- > 18 yrs.
- Admitted with a primary diagnosis of ulcerative colitis.
- Ulcerative colitis disease activity index score 6-12 (scale, 0-12).
- Mayo endoscopic subscore of 2 or greater.
- No prior treatment with infliximab.
- Patients with prior or ongoing exposure to non-infliximab biologic therapies, regardless of drug washout.
You may not qualify if…
- < 18 yrs.
- Other inflammatory bowel disease including Crohn's disease, indeterminate colitis, and microscopic colitis.
- Prior treatment with infliximab therapy.
- Contraindication to anti-TNF therapy.
Where it is running
- University of California at San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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