NCT06784076Not yet recruiting
Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue
Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Systemic Lupus Erythematosus (SLE) is a multi-system autoimmune disorder, characterised by activation of the interferon system. Of the multiple domains of this disease, patients identify fatigue as the most pervasive and disabling aspect. As many as 90% report significant levels of fatigue, a prevalence far in excess of that observed in the general population and most other chronic disorders. Moreover, its impact permeates all aspects of living as reflected by fatigue's strong relationship with impaired quality of life3 and work disability. Despite these substantial consequences, relatively little is known about this symptom and so the current dearth of accepted therapies is unsurprising. A better understanding of the underlying mechanisms of fatigue will be vital if efficacious interventions are to be developed in the future. The investigators will recruit 25 SLE patients to achieve 20 full data sets. They will attend for a baseline 7T brain scan to primarily measure basal ganglia glutamate and then receive 5 months of a pharmacological blocker that antagonises type 1 interferon receptors before completing the study with a final 7T brain scan to undertake repeat measure of basal ganglia glutamate.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 13 Jan 2025
- Start date
- 17 Mar 2025
- Primary completion date
- 17 Mar 2025
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Diseases
- Lupus (SLE)
- NCT number
- NCT06784076
What you commit to
- Study type: Observational
- Planned participants: 20
- From 17 Mar 2025 to the primary completion date, 17 Mar 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant biological therapies
- Current treatment with a biologic medicine or monoclonal antibody (including B cell depleting therapies in the previous 52 weeks)
- Previous exposure to anifrolumab
Other illness
- History of malignancy
- History of recurrent infections or known risk factors for infection
- Active or chronic infection
- Hypersensitivity to anifrolumab or excipients
- 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
Other
- 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
- 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).)
Who the study is looking for
- 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)
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.