Comparison of the Performance of SB2-Infliximab With Originator Infliximab in the Measure of Serum Concentrations in Serum

NCT03308357 | Unknown DMC FDA Drug

• 1 other identifier: MSD IIS-57047- GIBSON
• Study Type: observational
• Target: 6
• Locations: 0 countries
• Sites: N/A

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 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. 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. 2.To compare the effect of freeze-thawing and storage at 4 oC on concentrations of MSD-IFX.

Conditions

Inflammatory Bowel Diseases

Keywords

drug monitoring

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

All six subjects

2 patients with ulcerative colitis; one with active disease and one in remission. 2 patients with Crohn's disease; one with active disease and one in remission. 2 healthly controls. Single blood sample from each participant, serum collected, that serum will be spiked with known concentrations of the originator infliximab and the biosimilar infliximab and then run on a range of assays to measure infliximab drug concentrations

Diagnostic Test: Drug assays to measure infliximab

Interventions

Drug assays to measure infliximab DIAGNOSTIC_TEST

See protocol

All six subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending the inflammatory bowel disease outpatient clinics at Alfred Health. Healthy controls will be doctors attending the clinic

You may qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead
• Merck Sharp & Dohme LLC: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Mark G Ward, MBBS FRACP MD

CONTACT

+61390762223; m.ward@alfred.org.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: October 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share