Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis
|ClinicalTrials.gov Identifier: NCT01436019|
Recruitment Status : Unknown
Verified September 2011 by Miha Kosmac, Blood Transfusion Centre of Slovenia.
Recruitment status was: Not yet recruiting
First Posted : September 19, 2011
Last Update Posted : September 19, 2011
|Condition or disease|
|Juvenile Idiopathic Arthritis|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Analysis of Anti-infliximab, Anti-adalimumab and Anti-etanercept Antibodies in Children and Young Adolescents With Juvenile Idiopathic Arthritis|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2012|
|Estimated Study Completion Date :||December 2012|
Children or young adolescents with juvenile idiopathic arthritis receiving either infliximab, adalimumab or etanercept.
- Determination of the presence and quantification of anti-drug antibodies by ELISA or other immunoassay. [ Time Frame: Up to one year ]In patients receiving infliximab anti-infliximab antibodies will be measured, in patients receiving adalimumab anti-adalimumab antibodies will be measured and in patients receving etanercept anti-etanercept antibodies will be measured. In all cases the primary outcome measure will be the determination of the presence of these antibodies (YES/NO) and their quantification (in EqU compared to a reference serum) using ELISA or other suitable immunoassay.
- Determination of the presence and quantification of the serum level of the anti-TNF agent used for JIA therapy by ELISA or other immunoassay. [ Time Frame: Up to one year ]In patients receiving infliximab the trough serum level of infliximab will be measured, in patients receiving adalimumab the trough serum level of adalimumab will be measured and in patients receiving etanercept the trough serum level of etanercept will be measured by ELISA or other suitable immunoassay.
- Determination of the presence and quantification of the isotypes and subtypes of the anti-drug antibodies by ELISA or other immunoassay. [ Time Frame: Up to one year. ]In samples where the presence of anti-infliximab, anti-adalimumab or anti-etanercept antibodies will be confirmed, the isotypes and/or subtypes of the antibodies will be determined by ELISA or other suitable immunoassay.
- Time to first detection of anti-drug antibodies. [ Time Frame: Up to one year. ]The elapsed time from start of therapy until first detection of anti-drug antibodies will assessed.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436019
|Contact: Miha Kosmač, PhD||+386 1 5438 firstname.lastname@example.org|
|Contact: Tadej Avčin, MD, PhD||+386 1 522 96 email@example.com|
|University Medical Centre||Not yet recruiting|
|Principal Investigator: Tadej Avčin, MD, PhD|
|Principal Investigator:||Miha Kosmač, PhD||Blood Transfusion Centre of Slovenia|
|Study Director:||Tadej Avčin, MD, PhD||University Medical Centre, Ljubljana, Slovenia|
|Study Chair:||Vladka Čurin Šerbec, PhD||Blood Transfusion Centre of Slovenia|