Early Serum Infliximab Levels in Severe Ulcerative Colitis.

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Treatments: Infliximab

Criteria

Inclusion Criteria:

1. > 18 yrs.

2. Admitted with a primary diagnosis of ulcerative colitis.

3. Ulcerative colitis disease activity index score 6-12 (scale, 0-12).

4. Mayo endoscopic subscore of 2 or greater.

5. No prior treatment with infliximab.

6. Patients with prior or ongoing exposure to non-infliximab biologic therapies, regardless of drug washout.

Exclusion Criteria:

1. < 18 yrs.

2. Other inflammatory bowel disease including Crohn's disease, indeterminate colitis, and microscopic colitis.

3. Prior treatment with infliximab therapy.

4. Contraindication to anti-TNF therapy.