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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43545

Enrollment

280

Registered

2016-04-21

Start date

2016-09-23

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint: 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

Measure	Time frame
Secondary endpoint: - 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.	—

Measure

Time frame

Secondary endpoint: - 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.

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Countries

Netherlands

Outcome results