The purpose of this study is to methodically describe the patient experience of living with SLE, by studying the clinical features of the disease, how the disease progresses, how it is treated and how it affects quality of life. The study aims to look at the treatment outcomes and assess how patients with moderate to severe SLE utilize the available health resources. This study will also increase understanding of the type 1 interferon gene signature in SLE. A gene signature is a group of genes in a cell who may have an effect on cells, tissues or the medical condition.
This study is being done to see how safe an investigational drug is and how well it will work to help people with nonradiographic axial spondyloarthritis. Nonradiographic axial spondyloarthritis is a form of arthritis primarily affecting the spine and sacroiliac [SI] joints, but with no definite changes on x-rays. SI joints are next to the bottom of the spine on each side and above the tailbone.
Study I1F-MC-RHBV (RHBV) is a Phase 3, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group, outpatient study examining the efficacy and safety of 2 treatment regimens of ixekizumab, 80 mg Q2W and 80 mg Q4Wsubcutaneous (SC), as compared to placebo SC in patients with rad-axSpA, during a 16-week