Commercial Clinical Trials

UPSTAND: Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control in Radiographic Axial Spondyloarthritis This study will evaluate the effectiveness of Upadacitinib on early and sustained pain control in patients with radiographic axial spondyloarthritis in real world practice. This study will also explore the association between pain and clinical/patient-reported outcomes. Radiographic Axial Spondyloarthritis (r-axSpA) is an autoimmune disease which causes arthritis in the spine and pelvis. Patients have identified “pain” as their biggest unmet need in r-axSpA, and many report persistent pain, including back pain, which impacts disease activity and their quality of life. There is a lack of knowledge on pain in r-axSpA, including pain types, how it is localised and how these facets are impacted by treatment. There are currently no oral targeted therapies approved for the treatment of r-axSpA. Upadacitinib is an oral reversible inhibitor of Janus Kinase (JAK) which is an enzyme involved in inflammation. So far, there has only been one relatively small study looking at the therapeutic effect of Upadacitinib in patients with r-axSpA. Therefore, there is a need to obtain additional evidence on the impact of Upadacitinib on pain. This observational study will enroll patients that have been prescribed Upadacitinib by their treating physician. Participants will be followed up for one year and will be managed per routine clinical practice. Several patient-reported outcomes will also be collected electronically between visits and at routine clinical visits. This trial is now recruiting. This trial has received ethics approval from the Sydney Local Health District Human Research Ethics Committee (RPAH Zone). The sponsor of this trial is AbbVie Pty Ltd. PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH) SUB-INVESTIGATOR: Dr Bethan Richards (IMH; Rheumatology, RPAH) NCT04846244

TOPAZ-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of BIIB059 in Adult Participants With Active Systemic Lupus Erythematosus Receiving Background Nonbiologic Lupus Standard of Care The aim of this study is to investigate the effectiveness and safety of an investigational drug (BIIB059) in patients with active systemic lupus erythematosus, who are currently receiving treatment with background lupus standard of care therapy. Lupus is an autoimmune disease where the body’s immune system attacks itself, resulting in inflammation. Systemic lupus erythematosus (SLE) can affect many different parts of the body, but frequently involves the joints, skin, kidneys and blood cells. Most therapies used to treat SLE are only partially effective and have considerable toxicity. BIIB059 is a type of antibody developed to target certain cells thought to play a role in the development of lupus. Data from previous trials indicate that BIIB059 has the potential to decrease active lupus disease and control disease activity in SLE by inhibiting the production of some inflammatory mediators. Participants will be randomly assigned to one of three groups (placebo, BIIB059 225 mg or BIIB059 450 mg) and will receive these as subcutaneous (under the skin) injections every 4 weeks, up to a total of 52 weeks. This trial is now recruiting. This trial has received ethics approval from the St Vincent’s Hospital Melbourne Human Research Ethics Committee. The sponsor of this trial is Biogen Australia Pty Ltd. PRINCIPAL INVESTIGATOR: Professor Peter Youssef (Rheumatology, RPAH) SUB-INVESTIGATOR: Dr Matthew Parker (Rheumatology, RPAH) NCT04895241