Experimental protocols for investigating immunogenicity to biopharmaceuticals in patients with immune mediated inflammatory disease (IMIDs)

Completed

Conditions: Rheumatoid arthritis
10003816

Registration Number: NL-OMON45746

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 108

Inclusion Criteria

- Male and female patients of more than 18 years old diagnosed with an IMID
- Patients being treated in the usual manner in accordance with the terms of the marketing authorization and independently from entry into this study:
* Patients treated with Anti TNF therapy for over three months i.e. adalimumab, etanercept or infliximab in first line independently from inclusion into study or,
* Patients treated with Rituximab after failure with anti-TNF therapy or other biotherapy or given in first line or
* Patients treated with Tocilmumab after failure with anti-TNF therapy or other biotherapy or given in first line
- Having given written informed consent prior to undertaking any study-related procedures.
- Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.

Exclusion Criteria

- Under any administrative or legal supervision.
- Conditions/situations such as:
* Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
* Impossibility to meet specific protocol requirements (e.g. blood sampling)
* Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures
- Pregnant or breast-feeding women, currently or in the last three months prior to inclusion.
- Patients who have been vaccinated in the last three months prior to inclusion.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: activation, maturation and differentiation of biological<br /><br>specific lymphocytes.ten</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters/outcomes:<br /><br>- Ex-vivo evaluation of early biomarkers as potential predictors of<br /><br>immunogenicity<br /><br>- Evaluation of AD T cell response<br /><br>- T- and B-cell AD responses: clonality analysis and epitope mapping<br /><br>- Evaluation of B cell AD cellular response<br /><br>- Genetic susceptibility of ADA<br /><br><br /><br>Different variables will be evaluated; these techniques are still partly under<br /><br>construction. It involves serological, cellular, immunological and genetic<br /><br>markers. </p><br>