DECISION ON OPTIMAL COMBINATORIAL THERAPIES IN IMMUNE-MEDIATED INFLAMMATORY DISEASES (IMIDS) USING SYSTEMS APPROACHES

Condition studied

Psoriatic Arthritis, Rheumatoid Arthritis

Investigational medicinal product(s)

Eligibility

Primary endpoint

Proportion of patients who achieve disease remission at week 24 will be the primary endpoint. Remission will be defined by: • Clinical Disease Activity Index (CDAI) 2.8 or < 2.8 in RA • DAPSA <4 in PsA.

Endpoint detail

To provide proof-of-principle validation of the efficacy of combining TNF and IL-6 inhibitors achieve higher remission than current therapies in RA and PsA., To provide preliminary safety and tolerability data on the selected combination therapy and improvement in disease activity as measured by validated outcome measures.