Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001292763
Ethics application status
Approved
Date submitted
16/10/2013
Date registered
21/11/2013
Date last updated
21/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting response to biologics in inflammatory bowel disease
Scientific title
Predicting response to biologics in inflammatory bowel disease
Secondary ID [1] 283409 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 290319 0
Condition category
Condition code
Oral and Gastrointestinal 290718 290718 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study. Patients receiving biologic therapy for treatment of inflammatory bowel disease will be recruited. Disease activity will be recorded prior to therapy and during therapy. Blood samples will be collected just prior to a dose to measure concentrations of biologic drug and anti-drug antibodies, and both will be correlated with disease activity. This includes CDAI, HBI and SCCAI. Patients will be seen for blood samples and to record disease activity on between 1 or 3 occasions after starting therapy, after at least 12 weeks of therapy, when they are failing therapy and again if they change to a second biologic drug, after at least 12 weeks.
Intervention code [1] 288133 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290721 0
Response to biologic as determined by disease activity index is correlated with biologic trough concentration.
Timepoint [1] 290721 0
During treatment, at least 12 weeks after commencing treatment, compared to baseline.
Secondary outcome [1] 305093 0
Response to biologic as determined by disease activity index, correlated with anti-drug antibody concentration
Timepoint [1] 305093 0
At least 12 weeks after commencing treatment, compared to baseline

Eligibility
Key inclusion criteria
Patients with inflammatory bowel disease as determined by standard clinical and endoscopic criteria
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unwilling to provide informed consent

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2013
Actual
1/10/2013
Date of last participant enrolment
Anticipated
16/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 5520 0
New Zealand
State/province [1] 5520 0
Canterbury
Country [2] 5521 0
New Zealand
State/province [2] 5521 0
Otago

Funding & Sponsors
Funding source category [1] 288134 0
Hospital
Name [1] 288134 0
Christchurch Hospital Clinical Pharmacology department research fund
Country [1] 288134 0
New Zealand
Primary sponsor type
University
Name
University of Otago Christchurch
Address
P.O. Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 286851 0
None
Name [1] 286851 0
Address [1] 286851 0
Country [1] 286851 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290047 0
University of Otago Ethics Committee
Ethics committee address [1] 290047 0
P.O.Box 56
Dunedin 9054
Ethics committee country [1] 290047 0
New Zealand
Date submitted for ethics approval [1] 290047 0
Approval date [1] 290047 0
28/08/2013
Ethics approval number [1] 290047 0
13/040

Summary
Brief summary
Biologic agents have improved disease outcome for many patients with the inflammatory bowel diseases Crohn's disease and ulcerative colitis. However, about 50% patients fail to respond or lose response to treatment. There is some evidence that treatment failure correlates with low biologic drug trough concentrations and/or the presence of anti-drug antibodies. This study aims to examine this correlation in IBD patients in New Zealand with a view to using measurement of drug concentrations and anti-drug antibodies in those who are failing treatment to guide treatment decisions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43698 0
Prof Murray Barclay
Address 43698 0
Department of Clinical Pharmacology
Christchurch Hospital
Riccarton Avenue
Christchurch 8011
Country 43698 0
New Zealand
Phone 43698 0
+64 3 364 0074
Fax 43698 0
Email 43698 0
[email protected]
Contact person for public queries
Name 43699 0
Prof Murray Barclay
Address 43699 0
Department of Clinical Pharmacology
Christchurch Hospital
Riccarton Avenue
Christchurch 8011
Country 43699 0
New Zealand
Phone 43699 0
+64 3 364 0074
Fax 43699 0
Email 43699 0
[email protected]
Contact person for scientific queries
Name 43700 0
Prof Murray Barclay
Address 43700 0
Department of Clinical Pharmacology
Christchurch Hospital
Riccarton Avenue
Christchurch 8011
Country 43700 0
New Zealand
Phone 43700 0
+64 3 364 0074
Fax 43700 0
Email 43700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.