Status:
UNKNOWN
Comparison of the Performance of SB2-Infliximab With Originator Infliximab in the Measure of Serum Concentrations in Serum
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The measurement of serum concentrations of infliximab (IFX)has now become a routine part of optimal use of that drug. Trough values are used in two situations: (a) reactively where there is loss of re...
Detailed Description
EXPERIMENTAL PLAN Serum This will separated from peripheral blood taken from 2 healthy subjects, 2 patients with ulcerative colitis (one with quiescent and the other with active disease), and 2 patien...
Eligibility Criteria
Inclusion
- Crohn's disease and ulcerative colitis, deemed to be in remission or with active disease according to validated clinical scoring indices
- healthy controls
- Adult patients able to give informed consent to participate
Exclusion
- not meeting inclusion criteria
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03308357
Start Date
October 1 2017
End Date
March 1 2018
Last Update
October 13 2017
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