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

NCT01436019 | Unknown DMC

• 1 other identifier: BTC-PK-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Juvenile idiopathic arthritis; Rheumatic diseases; Antibodies; Biological therapy

Outcome Measures

Primary Outcomes (1)

• Determination of the presence and quantification of anti-drug antibodies by ELISA or other immunoassay.

  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 Outcomes (3)

• Determination of the presence and quantification of the serum level of the anti-TNF agent used for JIA therapy by ELISA or other 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.

  Up to one year.

• Time to first detection of anti-drug antibodies.

  Up to one year.

Study Arms (1)

anti-TNF treatment

Children or young adolescents with juvenile idiopathic arthritis receiving either infliximab, adalimumab or etanercept.

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• Clinical diagnosis of juvenile idiopathic arthritis
• Must be treated either with infliximab, adalimumab or etanercept

You may not qualify if:

• Contraindications to anti-TNF therapy
• Concurrent treatment with any biologic agent other than infliximab, etanercept, or adalimumab
• Previous treatment with rituximab

Sponsors & Collaborators

• Blood Transfusion Centre of Slovenia: lead
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

University Medical Centre

Ljubljana, Slovenia

Location

Related Publications (1)

• Kosmac M, Avcin T, Toplak N, Simonini G, Cimaz R, Curin Serbec V. Exploring the binding sites of anti-infliximab antibodies in pediatric patients with rheumatic diseases treated with infliximab. Pediatr Res. 2011 Mar;69(3):243-8. doi: 10.1203/PDR.0b013e318208451d.

  PMID: 21131896 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Arthritis, Juvenile; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Miha Kosmač, PhD

  Blood Transfusion Centre of Slovenia

  PRINCIPAL INVESTIGATOR

• Tadej Avčin, MD, PhD

  University Medical Centre, Ljubljana, Slovenia

  STUDY DIRECTOR

• Vladka Čurin Šerbec, PhD

  Blood Transfusion Centre of Slovenia

  STUDY CHAIR

Central Study Contacts

Miha Kosmač, PhD

CONTACT

+386 1 5438 146; miha.kosmac@ztm.si

Tadej Avčin, MD, PhD

CONTACT

+386 1 522 96 42; tadej.avcin@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 19, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 19, 2011

Record last verified: 2011-09

Locations

SL (1)