Rheumatoid arthritis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: activation, maturation and differentiation of biological specific lymphocytes.ten | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters/outcomes: - Ex-vivo evaluation of early biomarkers as potential predictors of immunogenicity - Evaluation of AD T cell response - T- and B-cell AD responses: clonality analysis and epitope mapping - Evaluation of B cell AD cellular response - Genetic susceptibility of ADA Different variables will be evaluated; these techniques are still partly under construction. It involves serological, cellular, immunological and genetic markers. | — |
Countries
Netherlands
Outcome results
None listed