2024-519884-16-00Not yet recruitingPhase 2
Ultimate dePletion of autoReactive b cells using Obinutuzumab from sjÖgren's syndrome affected Tissues study- UPROOT study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 2 Sept 2026
Brief summary (registry, in English)
To analyze if Obinutuzumab induces depletion of anti-nuclear antibody producing and rheumatoid factor B cells in affected tissues of patients with SjS.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 1 Jan 2026
- Lead sponsor
- Radboud universitair medisch centrum Stichting
- Diseases
- Sjögren's disease
- EU CT number
- 2024-519884-16-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with primary Sjögren's syndrome who have certain antibodies and signs of higher risk of lymphoproliferative disease. They must agree to tissue biopsies.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Primary Sjögren's syndrome meeting the EULAR/ACR 2016 classification criteria, with cryoglobulinemia and/or predictors of lymphoproliferative disease (for example rheumatoid factor antibodies, a history of lymphadenopathy, salivary gland swelling or purpuric lesions, or a lymphocytic focus score ≥ 3).
- Earlier treatment
- No earlier Obinutuzumab. No rituximab or other anti-CD20 therapy in the last 9 months. If it was 9-12 months ago, CD19+ B-cell count in blood must be at least 80 cells/microliter. No biologic or targeted synthetic DMARDs at the same time.
- Biomarker or test result
- ANA, anti-Ro60 and anti-La antibodies present.
Main reasons for not taking part
- Active infection or other active inflammatory condition
- Positive test for hepatitis B, hepatitis C or HIV
- Active tuberculosis, tuberculosis treated in the last 3 years, or untreated latent tuberculosis
- Positive pregnancy test or breast feeding
- Prednisone above 10 mg by mouth, or a change in prednisone dose in the last 4 weeks
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- 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).
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud universitair medisch centrum Stichting | Nijmegen | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.