Belimumab in SLE
EU CTIS ID: 2024-518966-28-00
What this study is testing
The primary goal of this study is to investigate the effects of belimumab on the composition of lymph nodes and the inflamed synovial tissue as well as (subsets of) immune cells in the peripheral blood. In addition, we will identify immunological alterations in lymphoid tissue and inflamed synovial tissue of SLE patients and to correlate these alterations with disease stage/phenotype, prognosis, and belimumab treatment response. We thereby aim to identify and validate novel biomarkers that can be used for personalized medicine in SLE.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- SLE patients who: 1. fulfill ACR 1997 and/or SLICC and/or ACR/ EULAR 2019 criteria 2. have a SLEDAI-2K score ≥6 3. active joint disease (arthritis) in wrist, knee or ankle joints (optional) 4. are aged between 18-75 5. start with belimumab For comparison reasons, we will also include 5 SLE patients who do not start belimumab but receive intensified treatment with other drugs (i.e. steroids or DMARDs) to discriminate belimumab-specific effects from general immunosuppressive effects. Patients are allowed to use stable dosages or concomitant medication such as hydroxychloroquine, azathioprine, and/or low dose steroids (<10 mg), as well as medication of therapeutic classes other than immunosuppressants. All patients will be counseled to use appropriate contraceptive measures as is done routinely in clinical care when prescribing these type of medications
You likely can't join if
- 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 (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131). Investigational agent applies to any drug not approved for sale in the country in which it is being used. 90 days prior to belimumab: • Intravenous cyclophosphamide 30 Days Prior to belimumab (or 5 half-lives, whichever is greater) • Any non-biologic investigational agent. Investigational agent applies to any drug not approved for sale in the country in which it is being use 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 infection: • Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) • Hospitalization for treatment of infection within 60 days of Day 0. • Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Day 0 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 a history of a primary immunodeficiency, including significant IgG deficiency (IgG level < 400 mg/dL) or IgA deficiency (IgA level < 10 mg/dL) 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 Hepatitis status: • Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows: patients positive for HBsAg or HBcAb are excluded • Positive test for Hepatitis C antibody Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies Have any other clinically significant abnormal laboratory value in the opinion of the investigator
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.