Study design
pSS
DISEASE, POLAND
This was a randomized, double-blind, placebo-controlled, parallel-group Phase IIA trial designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms in adult patients with moderate to severe pSS. Patients were randomized 1:1 to receive either oral RO5459072 [100 mg twice daily (BID), total of 200 mg daily] or matching placebo, and were treated for a maximum of 12 weeks. Patients were recruited between July 2016 and March 2017 in the USA (9 centres), France (3 centres), UK (4 centres), Germany (1 center), Poland (3 centres) and Portugal (3 centres).