Early phase development of anti-drug-antibodies in rheumatoid arthritis patients

Completed

Conditions: Rheumatoid arthritis
10023213

Registration Number: NL-OMON43545

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 280

Inclusion Criteria

- 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.

Exclusion Criteria

- 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 invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Immunization of anti-drug specific B cells against the BP<br /><br>defined by the presence of ADAb within the first 3 months<br /><br><br /><br>Study parameter: different variables will be evaluated; these techniques are<br /><br>still partly under construction. It involves serological, cellular,<br /><br>immunological and genetic markers. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoint:<br /><br>- B cell receptor (BCR) repertoire analysis of anti-drug specific B cells<br /><br>- Fingerprint of anti-drug specific B cell clones and clonal evolution over time<br /><br>- Characterization of anti-drug specific B cell clones (phenotype and receptor<br /><br>characteristic)<br /><br>- Quantification of ADAb at W0, W1, W2, M1, M3, M6 and M12<br /><br>- Drug levels<br /><br><br /><br>Study parameter: different variables will be evaluated; these techniques are<br /><br>still partly under construction. It involves serological, cellular,<br /><br>immunological and genetic markers. </p><br>