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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42704

Enrollment

Registered

2016-01-07

Start date

2015-08-01

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: - 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

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.

Design outcomes

Primary

Measure	Time frame
determination of antibodies against biologicals after 3 months.	—

Secondary

Measure	Time frame
determination of peptides in vivo after dosing of biologicals.	—

Countries

Netherlands

Outcome results