Anti -Infliximab or -Adalimumab Immunization (the AIAI study)

• Conditions: rheumatoid arthritis; 10003816; 10023213

• Registration Number: NL-OMON42704
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

- 18 years of age or older
- RA according to 2010 ACR/EULAR criteria
- Patients for whom the treating rheumatologist has decided to prescribe in routine practice in accordance with prescription guidelines for commercial use and independently from study entry:
o Adalimumab or Infliximab in first line.
o Adalimumab or Infliximab after failure with other anti-TNF therapy.
- Patient agreed to participate in the study by signing an informed consent.

Exclusion Criteria

- Patient under any administrative or legal supervision.
- Patients who were previously treated with Adalimumab or Infliximab.
- Impossibility to meet specific protocol requirements (e.g. blood sampling).
- Uncooperative patients or any condition that could make the patient potentially non-compliant to the study procedures.
- Pregnant or breast-feeding women.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>determination of antibodies against biologicals after 3 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>determination of peptides in vivo after dosing of biologicals.</p><br>