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

Active Locations (0)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 0 (0 locations)

No Results Found

We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.