Trial record 9 of 133 for:    "juvenile idiopathic arthritis" OR "Arthritis, Juvenile Rheumatoid"

Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Blood Transfusion Centre of Slovenia.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University Medical Centre Ljubljana
Information provided by (Responsible Party):
Miha Kosmac, Blood Transfusion Centre of Slovenia
ClinicalTrials.gov Identifier:
NCT01436019
First received: September 13, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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.


Condition
Juvenile Idiopathic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Anti-infliximab, Anti-adalimumab and Anti-etanercept Antibodies in Children and Young Adolescents With Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Blood Transfusion Centre of Slovenia:

Primary Outcome Measures:
  • Determination of the presence and quantification of anti-drug antibodies by ELISA or other immunoassay. [ Time Frame: Up to one year ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    The elapsed time from start of therapy until first detection of anti-drug antibodies will assessed.


Biospecimen Retention:   Samples Without DNA

Serum samples


Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
anti-TNF treatment
Children or young adolescents with juvenile idiopathic arthritis receiving either infliximab, adalimumab or etanercept.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436019

Contacts
Contact: Miha Kosmač, PhD +386 1 5438 146 miha.kosmac@ztm.si
Contact: Tadej Avčin, MD, PhD +386 1 522 96 42 tadej.avcin@kclj.si

Locations
Slovenia
University Medical Centre Not yet recruiting
Ljubljana, Slovenia
Principal Investigator: Tadej Avčin, MD, PhD         
Sponsors and Collaborators
Blood Transfusion Centre of Slovenia
University Medical Centre Ljubljana
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
  More Information

Publications:
Responsible Party: Miha Kosmac, dr., Blood Transfusion Centre of Slovenia
ClinicalTrials.gov Identifier: NCT01436019     History of Changes
Other Study ID Numbers: BTC-PK-1
Study First Received: September 13, 2011
Last Updated: September 16, 2011
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by Blood Transfusion Centre of Slovenia:
Juvenile idiopathic arthritis
Rheumatic diseases
Antibodies
Biological therapy

Additional relevant MeSH terms:
Arthritis, Juvenile Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014