Early phase development of antibodies against biologicals in rheumatoid arthritis patients
- Conditions
- Rheumatoid arthritis Anti-drug antibodies BiologicalsReumatoide artritis Antistoffen Biologicals
- Registration Number
- NL-OMON25457
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 280
Male and female patients of more than 18 years old diagnosed with rheumatoid arthritis according to 2010 ACR/EULAR criteria - Patient for whom the Treating Physician has decided to prescribe a BP in the usual manner in accordance with the terms of the marketing authorization and independently from entry into this study. - 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.
Received treatment with the same BP before (use of other BP previously is allowed). - Included in another study protocol. - 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunization of anti-drug specific B cells against the BP defined by the presence of ADAb within the first 3 months Study parameter: different variables will be evaluated; these techniques are still partly under construction. It involves serological, cellular, immunological and genetic markers.
- Secondary Outcome Measures
Name Time Method B cell receptor (BCR) repertoire analysis of anti-drug specific B cells - Fingerprint of anti-drug specific B cell clones and clonal evolution over time - Characterization of anti-drug specific B cell clones (phenotype and receptor characteristic) - Quantification of ADAb at W0, W1, W2, M1, M3, M6 and M12 - Drug levels Study parameter: different variables will be evaluated; these techniques are still partly under construction. It involves serological, cellular, immunological and genetic markers.