Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue

Launched by NHS GREATER GLASGOW AND CLYDE · Jan 17, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the causes of fatigue in patients with Systemic Lupus Erythematosus (SLE), an autoimmune disease that can affect various parts of the body. Fatigue is a common and often debilitating symptom for many SLE patients, with around 90% experiencing significant tiredness that can impact their daily lives. The study aims to explore the role of a specific pathway in the body linked to this fatigue, with hopes of finding better treatments in the future.

To participate in this trial, individuals must be adults aged 18 to 64 who have been diagnosed with SLE and experience persistent fatigue that affects their daily activities. Participants will undergo brain scans and receive a medication that targets a specific receptor in the body for five months. Throughout the trial, they will have their fatigue and brain activity closely monitored. This study is still in the planning stages and has not started recruiting participants yet. It’s important for potential participants to consider the eligibility criteria and any health conditions that might prevent them from joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults ≥ 18 years \< 65 years
• • Fulfilment of the 2019 ACR (American College of Rheumatology)/EULAR (European Alliance of Associations for Rheumatology) classification criteria for SLE
• • Persistent (\>3 months) and clinically significant fatigue (≥6 on numerical rating 0-10 scale measuring average level of fatigue during the past 7 days)
• • Attainment of Lupus low disease activity state (LLDAS)
• Exclusion Criteria:
• • Inability to provide informed written consent
• • Moderate or severe active SLE
• • Severe active CNS (Central Nervous System) Lupus and Lupus Nephritis
• • Contra-indications to anifrolumab
• • History of malignancy
• • History of recurrent infections or known risk factors for infection
• • Active or chronic infection
• • Concomitant biological therapies
• • Hypersensitivity to anifrolumab or excipients
• • Current treatment with a biologic medicine or monoclonal antibody (including B cell depleting therapies in the previous 52 weeks)
• • Previous exposure to anifrolumab
• • Contra-indications to MRI
• • Pregnant or breast-feeding
• • Females of child-bearing potential who do not agree to use an effective method of birth control until 12 weeks after the final study visit (See appendix 1).)
• • Severe physical impairment (e.g. blindness, paraplegia)
• • Medical or psychiatric conditions that in the judgement of the study personnel would preclude participation in the study