Authorised Therapeutic use (Phase IV) Systemic lupus erythematodes

Rituximab and obinutuzumab in SLE

EU CTIS ID: 2024-518965-85-00

What this study is testing

The primary goal of this study is to investigate the potential differential effects of RTX and OBI on the composition of lymph nodes and other target organs (i.e. skin and/or kidney) as well as (subsets of) immune cells in the peripheral blood. In addition, we will identify immunological alterations in lymphoid tissue and inflamed skin and/or kidney tissues of SLE patients and to correlate these alterations with disease stage/phenotype, prognosis, and 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

  • Inclusion criteria: SLE patients who: 1. fulfill ACR 1997 and/or SLICC and/or ACR/ EULAR 2019 criteria 2. have a SLEDAI-2K score ≥6 3. are aged between 18-75 4. are clinically determined to have severity of disease and refractoriness that supports the off-label use of anti-CD20 therapy

You likely can't join if

  • Exclusion criteria Patients who are not able to give informed consent.  Pregnancy  Severe renal impairment (eGFR <30ml/min/1.73m2 according to CKD-EPI formula)  Present or previous treatment with any cell depleting therapies, including anti-B-cell therapy, belimumab or other investigational agents (e.g., abetimus sodium, anti CD40L antibody, BG9588/ IDEC 131) in the last 3 years. Investigational agent applies to any drug not approved for sale in the country in which it is being used.  90 days prior to anti-CD20 therapy: • Intravenous cyclophosphamide  30 Days Prior to anti-CD20 therapy (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 anti-CD20 therapy  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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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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.