Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01105741
Status:
COMPLETED
Last Update Posted:
2014-02-05
First Post:
2010-04-12
Brief Title:
Metabolomic Analysis a Potential Tool to Direct Treatment With Adalimumab in Crohns Disease CD
Sponsor:
Martin Storr
Organization:
University of Calgary
Study Overview
Official Title:
Metabolomic Analysis a Potential Tool to Direct Treatment With Adalimumab in Crohns Disease CD
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MB
Brief Summary:
Background and Rationale Inflammatory bowel disease IBD is a major burden to individuals and society Ulcerative colitis and Crohns disease CD are the 2 major inflammatory bowel diseases IBD They share some pathologic and clinical features but overall their pathogenesis is not resolved and diagnosis is sometimes difficult The incidence rates range from 31 to 146 cases per 100000 person year for Crohns disease to 22 to 143 cases per 100000 person years for ulcerative colitis and prevalence ranges up to 201100000 for Crohns disease and up to 246100000 persons for ulcerative colitis
Powerful biological therapies were recently introduced for the treatment of CD They offer superior treatment for the treatment of steroid refractory patients Interestingly newer studies suggest that these therapies might also be beneficial if not superior if used at earlier stages of the disease But presently limitations of these treatments need to be considered and biomarkers that could better direct these treatments are urgently needed
One present limitation is that these new therapies though being beneficial in a large number of CD patients will not be beneficial to all CD patients Presently treatment responders and non-responders can not be identified prior to the treatment with the biological adalimumab representing an important unmet clinical need Since adalimumab treatment can be accompanied by serious potentially lethal side effects it would be a major advantage if future biomarkers could predict whether an individual will or will not respond to one or the other treatment
Furthermore with treatments available being associated with high costs to patients and society as the treatment with adalimumab is biomarkers that would help to identify potential treatment-responders or non-responders would support their targeted use and would be appreciated by all stakeholders
Nuclear magnetic resonance NMR spectroscopy is a method that generates comprehensive metabolic profiles from human biofluids and these metabolomic profiles may be useful to identify biomarkers with discriminative and predictive power in CD Thereby amongst other factors serum metabolites are affected by inflammation and urine metabolites are affected by gut flora and thus one or a combination of both may be a valuable tool in CD
Aim The investigators aim is to identify metabolomic predictors of clinical response to adalimumab treatment in CD patients in order to direct future treatment to a group of patients that is expected to benefit most
Methods Metabolomic profiling together with the collection of clinical data will be performed in patients with IBD prior to treatment with biological therapy and for up to 6 month thereafter
In the study the investigators follow 50 patients with Crohns Disease naive to treatment with biologics Metabolomic profiling will be performed 1 week prior to the treatment with adalimumab and then every 4 weeks for 6 month In order to be reliable and reproducible sampling will be performed in the morning after an overnight fasting period On the days of serumurine collection the following data will be collected CBC ESR CRP Calprotectin ASCApANCA IL-10 TNFα IFNγ Crohns disease Activity Index present medication and OTC Dietary and lifestyle history including 24 hour dietary recall alcohol intake smoking and exercise
Multivariate analysis will be performed to identify patterns in the metabolomic profile that predict response or non-response to adalimumab treatment
To summarize IBD is a major burden to patients and society Adalimumab treatment is helpful in steroid refractory patients Novel biomarkers that help physicians to decide which patient might benefit from adalimumab treatment may be powerful tools to optimize directing these powerful but expensive and side effect bearing therapies towards the patient that might benefit most Metabolomic profiling may be the tool that helps us to identify these patients
Powerful biological therapies were recently introduced for the treatment of CD They offer superior treatment for the treatment of steroid refractory patients Interestingly newer studies suggest that these therapies might also be beneficial if not superior if used at earlier stages of the disease But presently limitations of these treatments need to be considered and biomarkers that could better direct these treatments are urgently needed
One present limitation is that these new therapies though being beneficial in a large number of CD patients will not be beneficial to all CD patients Presently treatment responders and non-responders can not be identified prior to the treatment with the biological adalimumab representing an important unmet clinical need Since adalimumab treatment can be accompanied by serious potentially lethal side effects it would be a major advantage if future biomarkers could predict whether an individual will or will not respond to one or the other treatment
Furthermore with treatments available being associated with high costs to patients and society as the treatment with adalimumab is biomarkers that would help to identify potential treatment-responders or non-responders would support their targeted use and would be appreciated by all stakeholders
Nuclear magnetic resonance NMR spectroscopy is a method that generates comprehensive metabolic profiles from human biofluids and these metabolomic profiles may be useful to identify biomarkers with discriminative and predictive power in CD Thereby amongst other factors serum metabolites are affected by inflammation and urine metabolites are affected by gut flora and thus one or a combination of both may be a valuable tool in CD
Aim The investigators aim is to identify metabolomic predictors of clinical response to adalimumab treatment in CD patients in order to direct future treatment to a group of patients that is expected to benefit most
Methods Metabolomic profiling together with the collection of clinical data will be performed in patients with IBD prior to treatment with biological therapy and for up to 6 month thereafter
In the study the investigators follow 50 patients with Crohns Disease naive to treatment with biologics Metabolomic profiling will be performed 1 week prior to the treatment with adalimumab and then every 4 weeks for 6 month In order to be reliable and reproducible sampling will be performed in the morning after an overnight fasting period On the days of serumurine collection the following data will be collected CBC ESR CRP Calprotectin ASCApANCA IL-10 TNFα IFNγ Crohns disease Activity Index present medication and OTC Dietary and lifestyle history including 24 hour dietary recall alcohol intake smoking and exercise
Multivariate analysis will be performed to identify patterns in the metabolomic profile that predict response or non-response to adalimumab treatment
To summarize IBD is a major burden to patients and society Adalimumab treatment is helpful in steroid refractory patients Novel biomarkers that help physicians to decide which patient might benefit from adalimumab treatment may be powerful tools to optimize directing these powerful but expensive and side effect bearing therapies towards the patient that might benefit most Metabolomic profiling may be the tool that helps us to identify these patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None