Investigating the effects of belimumab on immune cells in lupus patients

The Effects of Belimumab on Synovial Inflammation and Composition of Lymph Nodes in SLE Patients

This study is testing how the drug belimumab changes immune cells in people with lupus to see if it can help improve their treatment.

Quick facts

• Study type: Observational
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Drugs / interventions: belimumab, cyclophosphamide
• Locations: 1 site (Amsterdam)
• Trial ID: NCT06327724 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore how belimumab affects the composition of lymph nodes and inflamed synovial tissue in patients with systemic lupus erythematosus (SLE). It will utilize advanced flow cytometry and single-cell RNA sequencing to analyze immune cell alterations and their correlation with disease stage, prognosis, and treatment response. By identifying and validating novel biomarkers, the study seeks to enhance personalized medicine approaches for SLE patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with active joint disease and a SLEDAI-2K score of 6 or higher who are starting belimumab or other immunosuppressive treatments.

Not a fit: Patients with severe renal impairment, active nephritis, or those who have received certain prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with systemic lupus erythematosus.

How similar studies have performed: Previous studies have shown success in identifying biomarkers in similar immune-mediated inflammatory diseases, suggesting potential for this approach in SLE.

Eligibility criteria

Inclusion Criteria:

SLE patients who:

1. fulfill ACR 1997 and/or SLICC and/or ACR/ EULAR 2019 criteria,
2. have active joint disease (arthritis) in wrist, knee or ankle joints.
3. have a SLEDAI-2K score ≥6.
4. are aged between 18-75
5. start with belimumab or any other immunosuppressive treatment

Exclusion Criteria:

* Patients who are not able to give informed consent.
* Pregnancy
* Severe renal impairment (eGFR \<30ml/min/1.73m2)
* Active nephritis
* Present or previous treatment with any cell depleting therapies, including anti-B-cell therapy or other investigational agents
* Intravenous cyclophosphamide 90 days prior to belimumab
* Any non-biologic investigational agent 30 Days Prior to belimumab (or 5 half-lives, whichever is greater)
* Live vaccines within 30 days prior to baseline or concurrently with belimumab
* Presence of any other disease for which study subjects need chronic or intermittent immunosuppressive therapy (e.g. prednisolon for COPD).
* History of malignancies neoplasm within the last 5 years except basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterine cervix treated locally and with no evidence of metastatic disease for 3 years
* Have any intercurrent significant medical or psychiatric illness that the investigator considers would make the candidate unsuitable for the study, including evidence of serious suicide risk including any history of suicidal behaviour in the last 6 months and/or any suicidal ideation in the last 2 months or who in the investigator's judgment, poses a significant suicide risk
* Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 365 days prior to Day 0
* Have a historically positive HIV test or test positive at screening for HIV, or other immunodeficiency

Where this trial is running

Amsterdam

• Amsterdam UMC; location Academic Medical Center — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Sander W Tas, Prof. dr.

Conditions: Systemic Lupus Erythematosus, lymph node, synovial tissue