An observational post-approval safety study of golimumab in treatment of polyarticular Juvenile Idiopathic Arthritis (pJIA) using the German Biologics JIA Registry (BiKeR) (MK-8259-050)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AB06) golimumab

  golimumab
• Medical condition to be studied:
  Juvenile idiopathic arthritis

Population studied

• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  3258

Study design details

• Main study objective:
  To evaluate long-term GLM safety in treatment of pJIA by describing risk of primary safety endpoints for 4 cohorts: serious infections, malignancy, autoimmune processes, exposure during pregnancy, and to compare the risks in GLM vs. other cohorts.
• Outcomes:
  Serious infections (including opportunistic infections, TB and hepatitis B reactivation), malignancy, autoimmune processes (including thyroiditis, autoimmune diabetes, uveitis, psoriasis, IBD, celiac disease, demyelinating disorders, as well as SLE), exposure during pregnancy. Incidence of demyelinating disorders, serious depression including suicidality, PedACR 30/50/70/90 & JADAS-10 scores, treatment duration/discontinuation.
• Data analysis plan:
  For primary safety endpoints, frequency/incidence rate will be calculated for each cohort. Subgroup analyses stratified by history of prior anti-TNF use will be done if data permit. For secondary safety endpoints, frequency/incidence rate will be calculated for the GLM cohort, and two contemporary comparator cohorts. For historic anti-TNF cohort, frequencies/incidence rates will be calculated only for those secondary endpoints systematically collected during the historic observation period. For GLM cohort, treatment response will be described at months 3, 6, 12, and 24 compared to baseline. For GLM cohort, treatment duration and reasons for GLM discontinuation will be described. Comparative analyses between GLM and two contemporary comparator cohorts may be done for primary safety outcomes adjusting for potential confounders in the final report.