Goal: Safety in therapy

The most important concern of the Registry is to assess the safety of treatment for rheumatoid arthritis.

Adverse events (UE) and serious adverse events (SUE) are all medically relevant occurrences during the observation period, irrespective of any possible causal relationship with a therapy.

Pregnancies of the patient’s partner are also medically relevant. We therefore ask you to document a pregnancy, even if it is planned and desired, in the same way as an “adverse event”.

Adverse events

  • all newly occurring subjective and objective diseases or symptoms
  • all adverse drug reactions, in particular allergic reactions and infusion incidents
  • UE lasting since last measurement time
  • worsening of concomitant diseases
  • Pregnancies, births, abortions, miscarriages

Serious adverse events

  • UE with death result
  • life-threatening UE
  • UE with hospital stay (also planned operations, but no inpatient rehabilitation)
  • Malformations, birth defects
  • UE leading to persistent or significant functional impairment or disability
  • other UE associated with an acute or significant risk (e.g. allergic bronchospasm, seizure)