- Subject eligibility should be reviewed and documented by an appropriately qualified
member of the investigator's study team before subjects are included in the study.
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study is a requirement for inclusion into this study.
Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the study:
- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
- Definitive diagnosis of RA or PsA.
- Eligible for Etanercept treatment according to Summary of Product Characteristics
(SmPC).
- Inclusion of subjects pretreated with other biologics other than Etanercept is
possible
- One plain radiograph of hands and feet (Anteroposterior) within 3 month prior to
initiation of treatment with Etanercept and one planned consecutive radiograph of hand
and feet taken over 12 to 18 months according to German recommendations for patients
treated with biologics.
- Receipt of any investigational drug within 3 months of study inclusion.
- Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:
- Hypersensitivity to the active substance (etanercept) or to any of the excipients.
- Sepsis or risk of sepsis.
- Active infections, including chronic or localised infections.
- Subjects who have received any previous treatment with etanercept
- Subjects who are investigational site staff members or subjects who are Pfizer
employees directly involved in the conduct of the trial.