Date

2015-11-02

Protocol

Protocol changed

Item Changed

Interventions (study centers) The following sites were closed due to Non-recruitment; National Hospital of Sri Lanka and Teaching Hospital Kandy.

Previous Version

1. Study centres in Sri Lanka: • National Hospital, Colombo • Sri Jayawardenapura General Hospital • Teaching Hospital Kandy 2. Number of arms: 2 Participants randomized to the intervention arm will receive Blisibimod 200mg by subcutaneous injection once a week for 52 weeks. Participants in the control arm will receive a matching placebo by subcutaneous injection once a week for 52 weeks. All participants will receive standard of care including corticosteroids, immunosuppressive agents and anti-malarials as per physician discretion.

Next Version

1. Study centres in Sri Lanka: • Sri Jayawardenapura General Hospital 2. Number of arms: 2 Participants randomized to the intervention arm will receive Blisibimod 200mg by subcutaneous injection once a week for 52 weeks. Participants in the control arm will receive a matching placebo by subcutaneous injection once a week for 52 weeks. All participants will receive standard of care including corticosteroids, immunosuppressive agents and anti-malarials as per physician discretion.