Rheumatoid Arthritis
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Male and female patients of more than 18 years old diagnosed with RA according to 2010 ACR/EULAR criteria - Patient for whom the Treating Physician has decided to prescribe in the usual manner in accordance with the terms of the marketing authorization and independently from entry into this study: • Adalimumab, etanercept, infliximab, infliximab biosimilar, rituximab OR tocilizumab in first line or after failure with other biotherapy. In case of previous rituximab treatment, inclusion may be possible at least 12 months after the last rituximab infusion or, • Subcutaneous form of tocilizumab, either as first line or after switch from infusion tocilizumab form is allowed. - 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: - Under any administrative or legal supervision. - Patients having previously received rituximab in the past 12 months. - Conditions/situations such as: • Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint • Requirement for concomitant treatment that could bias primary evaluation • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Measurement of antibodies agains biological after 1 year. 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 |
|---|---|
| Secundary outcomes: 1. secundary non-response 2. therapy related potential immunologic mediated events. Study parameter: different variables will be evaluated; these techniques are still partly under construction. It involves serological, cellular, immunological and genetic markers. | — |
Countries
Netherlands
Outcome results
None listed