Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01584687
Status:
UNKNOWN
Last Update Posted:
2012-04-25
First Post:
2012-04-20
Brief Title:
mRNA Expression as a Biomarker of Omalizumab Response
Sponsor:
Instituto de Investigação em Imunologia
Organization:
Instituto de Investigação em Imunologia
Study Overview
Official Title:
mRNA Expression as a Biomarker of Xolair Omalizumab Response
Status:
UNKNOWN
Status Verified Date:
2012-04
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
Objectives 1 Determine if mRNA expression could be use as a biomarker to predict and monitor the response to omalizumab in patients with difficult control asthma 2 Identify which genes are switched on and which are switched off by using Omalizumab
Methods This study is an open label clinical trial with six patients The patients will receive Omalizumab according to their age and weight maximum dose 375 mg every 15 days for 4 months There will be a run-in period of one month when allergic asthma diagnosis will be confirmed and treatment will be optimized Patients will be evaluated and will have blood sample collected on 3 occasions in the beginning 2 months after baseline and at the end of the study Blood samples will always be collected one week after the last omalizumab dose Primary outcome will be RNA expression of 20 genes measured by real time-PCR high-affinity IgE receptor IL-4 IL-5 IL-13 gama-IFN quimokines Fc epsilon between others Secondary outcomes will be ACT ACQ and spirometry
Methods This study is an open label clinical trial with six patients The patients will receive Omalizumab according to their age and weight maximum dose 375 mg every 15 days for 4 months There will be a run-in period of one month when allergic asthma diagnosis will be confirmed and treatment will be optimized Patients will be evaluated and will have blood sample collected on 3 occasions in the beginning 2 months after baseline and at the end of the study Blood samples will always be collected one week after the last omalizumab dose Primary outcome will be RNA expression of 20 genes measured by real time-PCR high-affinity IgE receptor IL-4 IL-5 IL-13 gama-IFN quimokines Fc epsilon between others Secondary outcomes will be ACT ACQ and spirometry
Detailed Description:
Study rational There is not a biomarker that can predict which patients will respond to Omalizumab and those who will not respond Nowadays the monitoring of therapeutic response to Omalizumab is based on clinical and spirometric data
On the other hand when a medication is administered it has its main expected effect but also acts on other targets with various direct and indirect effects We do not know all the genes that are switched on and those that are switched off by the use of Omalizumab For example anti-IgE has been developed to block serum total IgE and thereby improve control of allergic asthma However the studies noted that Omalizumab also reduces the receptors FcepsilonRI which may have implications for the treatment of autoimmune urticaria
On the other hand when a medication is administered it has its main expected effect but also acts on other targets with various direct and indirect effects We do not know all the genes that are switched on and those that are switched off by the use of Omalizumab For example anti-IgE has been developed to block serum total IgE and thereby improve control of allergic asthma However the studies noted that Omalizumab also reduces the receptors FcepsilonRI which may have implications for the treatment of autoimmune urticaria
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