Trials Sponsors Conditions Drugs Pricing

Conditions

Juvenile Idiopathic Arthritis Rheumatoid Arthritis

Keywords

Rheumatoid arthritisJuvenile Idiopathic ArthritisBiopharmaceuticalImmunogenicityAnti-Drug AntibodyPrediction

Outcome Measures

Primary Outcomes (1)

Immunization against the Biopharmaceutical defined by the presence of ADAb within the first 12 months (or W52)
52 weeks

Secondary Outcomes (15)

Quantification of ADAb
at Week 0
Quantification of ADAb
at Week 4
Quantification of ADAb
at Week 12
Quantification of ADAb
at Week 26
Quantification of ADAb
at Week 52
+10 more secondary outcomes

Study Arms (1)

Global population

OTHER

All included patients : Sampling of blood

Procedure: Sampling of blood

Interventions

Sampling of bloodProcedure

Sampling of blood for dosage of antibodies

Global population

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male and female patients of more than 18 years old diagnosed with RA according to 2010 ACR/EULAR criteria Or Male and female patients Age \> 2 years and \<18 years, diagnosed with JIA according to the Internal League Against Rheumatism (ILAR) classification criteria.
Patient for whom the Treating Physician has decided to prescribe in the usual manner in accordance with the terms of the marketing authorization and independently from entry into this study:

Sponsors & Collaborators

Pediatric Rheumatology International Trials Organization
Othercollaborator
University College London (UCL) Cancer Institute
Othercollaborator

Study Sites (1)

CHU Bicêtre

Le Kremlin-Bicêtre, 94275, France

Related Publications (3)

Paoletti A, Ly B, Bitoun S, Nocturne G, Riviere E, Manson JJ, Matucci A, Pallardy M, De Vries N, Mariette X. Restoration of Default Blood Monocyte-Derived Macrophage Polarization With Adalimumab But Not Etanercept in Rheumatoid Arthritis. Front Immunol. 2022 Feb 23;13:832117. doi: 10.3389/fimmu.2022.832117. eCollection 2022.
PMID: 35281074DERIVED
Duhaze J, Caubet M, Hassler S, Bachelet D, Allez M, Deisenhammer F, Fogdell-Hahn A, Gleizes A, Hacein-Bey-Abina S, Mariette X, Pallardy M, Broet P; ABIRISK Consortium. Assessing the effect of genetic markers on drug immunogenicity from a mechanistic model-based approach. BMC Med Res Methodol. 2020 Mar 20;20(1):69. doi: 10.1186/s12874-020-00941-z.
PMID: 32192445DERIVED

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis, Juvenile

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Xavier Mariette, MD, PhD
Assistance Publique - Hôpitaux de Paris
PRINCIPAL INVESTIGATOR

Enrollment

156 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 17, 2014

Study Start

April 2014

Date type not reported

This date has not been verified as actual or estimated.

Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk of Immunization in Rheumatoid Arthritis Patients or Juvenile Idiopathic Arthritis Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (1)

Global population

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (1)

Global population

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations