NL-OMON43545CompletedNot Applicable
Early phase development of anti-drug-antibodies in rheumatoid arthritis patients - early ADA
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 280
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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