Ultimate dePletion of autoReactive b cells using Obinutuzumab from sjÖgren's syndrome affected Tissues study- UPROOT study
Key facts
- Where
- Nijmegen, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Radboud universitair medisch centrum Stichting
- Trial code
- EU 2024-519884-16-00
- Record updated
- 2026. szeptember 2.
- Original description
To analyze if Obinutuzumab induces depletion of anti-nuclear antibody producing and rheumatoid factor B cells in affected tissues of patients with SjS.Read full original descriptionShow less
To analyze if Obinutuzumab induces depletion of anti-nuclear antibody producing and rheumatoid factor B cells in affected tissues of patients with SjS.
Inclusion: adult patients, age ≥ 18 years; patients with with primary SjS fulfilling the EULAR/ACR 2016 classification criteria; Presence of ANA, anti-Ro60, anti-La; Cryoglobulinemia and/or previous predictors for development lymphoproliferative disease. These consist of at least one of the following: - detectable rheumatoid factor antibodies - a history of lymphadenopathy - a history of salivary gland swelling - a history of purpuric lesions or biopsy-proven vasculitis - a lymphocytic focus score ≥ 3 in a salivary gland biopsy performed for diagnosis or for screening; In female patients: use of reliable method of contraception during the study and at least until 18 months after the last injection, in women of child bearing potential; signed written informed consent; Willingness to undergo study procedures, including tissue biopsies as described in the informed consent.
Exclusion: presence of active concurrent inflammatory or infectious condition; Necessity to immunize with live or attenuated viral vaccines during treatment with Obinutuzumab and until B-cell recovery; previous experience with Obinutuzumab through a clinical trial or regular treatment; concomitant use of any biologic DMARDs etanercept, adalimumab, infliximab, anakinra, abatacept, tocilizumab, certolizumab, golimumab) or targeted synthetic DMARDs tofacitinib, baracitinib or filgotinib; concurrent treatment with prednisone > 10 mg orally; change in prednisone dosage within 4 weeks before the baseline visit; change in prednisone dosage within 4 weeks before the baseline visit; treatment with intra-muscular, intra-articular or intravenous prednisone 4 weeks before the baseline visit; positive serology for hepatitis B, C or Human Immunodeficiency Virus; uncooperative or any condition that could make the patient potentially noncompliant to the study procedures, etc, and, as applicable in the Netherlands, individuals who are institutionalized due to regulatory or legal order; opportunistic infection in the preceding 3 months; Subjects with a history of active TB treated within the last 3 years; liver cirrhosis or severe renal insufficiency; treatment with rituximab or any other anti-CD20 therapy < 9 months before inclusion. - In patients treated with rituximab or any other anti-CD20 therapy 9-12 months before inclusion: A CD19+ B-cell count in peripheral blood of < 80 cells/microliter; Subjects with current clinical or laboratory evidence of active tuberculosis(TB); patients for whom Obinutuzumab is contra-indicated as described in the local label (SmPc); patients currently participating in any interventional clinical trials; positive pregnancy test or breast feeding; Subjects with untreated latent TB; heavy alcohol consumption (>3 drinks/day).