Belimumab in SLE Synovial Inflammation and Lymph Nodes

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called belimumab on patients with systemic lupus erythematosus (SLE), a condition where the immune system mistakenly attacks the body. Researchers want to understand how belimumab affects different parts of the immune system, especially in lymph nodes, blood, and joints. By comparing these areas, they hope to gain insights into the disease and improve treatment options for patients.

To join the trial, participants must be between 18 and 75 years old and have active joint disease, such as arthritis in the wrist, knee, or ankle. They should also meet specific diagnostic criteria for SLE and have a certain level of disease activity. Participants will undergo procedures like lymph node biopsies and joint assessments, which are considered safe and have been performed many times before. This study aims to help identify better treatment strategies for SLE, making it an important step toward improving care for those affected by this challenging condition.

Gender

ALL

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