- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01436019
Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis
September 16, 2011 updated by: Miha Kosmac, Blood Transfusion Centre of Slovenia
Analysis of Anti-infliximab, Anti-adalimumab and Anti-etanercept Antibodies in Children and Young Adolescents With Juvenile Idiopathic Arthritis
The purpose of this study is to analyze the frequency of the formation of antibodies against three different anti-TNF biologic agents used for the therapy of juvenile idiopathic arthritis.
Study Overview
Status
Unknown
Conditions
Detailed Description
Juvenile idiopathic arthritis (JIA) is the umbrella term for a heterogeneous group of inflammatory arthropathies that can affect children and young adults and is the most common rheumatic disease of the pediatric population.
In high-income countries it has a yearly incidence of 2-20 cases per 100 000 population and a prevalence of 16-150 cases per 100 000 population.
Treatment of JIA includes a combination of pharmacological interventions, physical and occupational therapy, and psychosocial support.
Although a definitive cure is still not available, the prognosis for patients with JIA has improved greatly in recent years due to improved disease management and with the introduction of biologics that can provide an efficient alternative for patients who are nonresponsive to other treatments.
Traditionally, biologic treatments in JIA have focused on blocking one of the central mediators of the inflammatory response, the cytokine tumor necrosis factor (TNF).
Currently there are three anti-TNF agents available for the treatment of JIA: infliximab, adalimumab and etanercept.
One of the major drawbacks of these therapeutics is the production of anti-drug antibodies (ADA) that have been correlated with an increased risk of adverse events and loss of drug efficacy.
The study will evaluate the frequency of the formation of anti-infliximab antibodies in patients treated with infliximab, anti-adalimumab antibodies in patients treated with adalimumab and anti-etanercept antibodies in patients treated with etanercept.
A common practice in cases nonresponsive to one of the described anti-TNF agents is the discontinuation of therapy and switching to a different ant-TNF agent.
Therefore, the frequency of the formation of antibodies to each of the described anti-TNF agents will also be compared between patients who have previously received a different anti-TNF agent and patients who have not received any previous anti-TNF therapy.
The results of this study will highlight the risks of formation of antibodies to three different anti-TNF biologic agents used for the therapy of JIA either alone or after the previous discontinuation of a different anti-TNF agent.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Miha Kosmač, PhD
- Phone Number: +386 1 5438 146
- Email: miha.kosmac@ztm.si
Study Contact Backup
- Name: Tadej Avčin, MD, PhD
- Phone Number: +386 1 522 96 42
- Email: tadej.avcin@kclj.si
Study Locations
-
-
-
Ljubljana, Slovenia
- University Medical Centre
-
Principal Investigator:
- Tadej Avčin, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- Clinical diagnosis of juvenile idiopathic arthritis
- Must be treated either with infliximab, adalimumab or etanercept
Exclusion Criteria:
- Contraindications to anti-TNF therapy
- Concurrent treatment with any biologic agent other than infliximab, etanercept, or adalimumab
- Previous treatment with rituximab
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
anti-TNF treatment
Children or young adolescents with juvenile idiopathic arthritis receiving either infliximab, adalimumab or etanercept.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to one year
|
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.
|
Up to one year.
|
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.
|
Up to one year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
October 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
September 13, 2011
First Submitted That Met QC Criteria
September 16, 2011
First Posted (Estimate)
September 19, 2011
Study Record Updates
Last Update Posted (Estimate)
September 19, 2011
Last Update Submitted That Met QC Criteria
September 16, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTC-PK-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Juvenile Idiopathic Arthritis
-
University of AarhusAarhus University HospitalCompletedPolyarticular Juvenile Rheumatoid Arthritis | Systemic Juvenile Idiopathic Arthritis | Juvenile Idiopathic Arthritis, OligoarthritisDenmark
-
GeneScience Pharmaceuticals Co., Ltd.Not yet recruitingActive Systemic Juvenile Idiopathic ArthritisChina
-
Institut National de la Santé Et de la Recherche...CompletedSystemic-Onset Juvenile Idiopathic ArthritisFrance
-
Novartis PharmaceuticalsCompletedSystemic Juvenile Idiopathic Arthritis (SJIA)Italy, Russian Federation, Turkey, Belgium, Spain, Germany, France, Israel, Canada, United States, Hungary, Austria, Brazil, Sweden, Netherlands, Poland
-
Novartis PharmaceuticalsPediatric Rheumatology International Trials OrganizationCompletedSystemic Juvenile Idiopathic Arthritis With Active FlareUnited States, Argentina, Canada, Switzerland, Germany, Israel, South Africa, Belgium, Italy, Spain, France, Brazil, Turkey, Hungary, Poland, Norway, Sweden, Netherlands, Peru
-
University of British ColumbiaUniversity of Manitoba; The Hospital for Sick Children; McGill University Health... and other collaboratorsRecruiting
-
AbbVieCompletedPolyarticular Juvenile Idiopathic Arthritis
-
NovartisCompletedArthritis, Juvenile RheumatoidItaly
-
AbbottCompletedArthritis, Juvenile IdiopathicUnited States, Belgium, Czech Republic, France, Germany, Italy, Slovakia, Spain
-
Assistance Publique - Hôpitaux de ParisRecruitingJuvenile Idiopathic Arthritis (JIA)France