Inflammatory Bowel Diseases Clinical Trial
Official title:
Comparison of the Performance of SB2-Infliximab With Originator Infliximab in the Measure of Serum Concentrations in Serum
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 response to infliximab - therapeutic concentrations are indicate likely
non-response to the drug, whereas low levels are associated with the chance of regaining
response by increasing dosage; or (b) proactively, where dose optimisation in the maintenance
phase is performed to ensure ongoing efficacy and/or cost-effective use (where high levels
lead to reduction in dosage without loss of efficacy).
With the introduction of biosimilar infliximab into clinical practice, it is important to
demonstrate that the biosimilar behaves similarly in the assay used as does originator
infliximab to which the assays were developed. While unlikely to be different due to
identical protein core, such confirmation is needed before such assays can be used in
clinical practice with confidence.
AIMS
1. To compare the concentrations of biosimilar IFX (MSD-IFX) with that of originator IFX
(orig-IFX) when added to serum form healthy subjects and those with IBD when measured by
commonly-used commercial assays.
2. To compare the effect of freeze-thawing and storage at 4 oC on concentrations of
MSD-IFX.
Status | Not yet recruiting |
Enrollment | 6 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - not meeting inclusion criteria |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Alfred | Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drug levels of infliximab originator and biosimilar infliximab | Infliximab drug levels will be measured on a range of commercially available drug assays | Over the study duration (6 months) |
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