NL-OMON45746
Completed
Not Applicable
Experimental protocols for investigating immunogenicity to biopharmaceuticals in patients with immune mediated inflammatory disease (IMIDs) - Cross-sectional ABIRISK project
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 108
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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