Obinutuzumab for Sjögren's syndrome

Inclusion criteria

• {"criterion_text":"- adult patients, age ≥ 18 years."}
• {"criterion_text":"- patients with with primary SjS fulfilling the EULAR/ACR 2016 classification criteria"}
• {"criterion_text":"- Presence of ANA, anti-Ro60, anti-La."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- signed written informed consent."}
• {"criterion_text":"- Willingness to undergo study procedures, including tissue biopsies as described in the informed consent."}

Exclusion criteria

• {"criterion_text":"- presence of active concurrent inflammatory or infectious condition."}
• {"criterion_text":"- patients for whom Obinutuzumab is contra-indicated as described in the local label (SmPc)."}
• {"criterion_text":"- Necessity to immunize with live or attenuated viral vaccines during treatment with Obinutuzumab and until B-cell recovery."}
• {"criterion_text":"- patients currently participating in any interventional clinical trials."}
• {"criterion_text":"- previous experience with Obinutuzumab through a clinical trial or regular treatment"}
• {"criterion_text":"- concomitant use of any biologic DMARDs etanercept, adalimumab, infliximab, anakinra, abatacept, tocilizumab, certolizumab, golimumab) or targeted synthetic DMARDs tofacitinib, baracitinib or filgotinib or any classical DMARD."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- concurrent treatment with prednisone > 10 mg orally."}
• {"criterion_text":"- change in prednisone dosage within 4 weeks before the baseline visit"}
• {"criterion_text":"- change in prednisone dosage within 4 weeks before the baseline visit"}
• {"criterion_text":"- treatment with intra-muscular, intra-articular or intravenous prednisone 4 weeks before the baseline visit."}
• {"criterion_text":"- positive serology for hepatitis B, C or Human Immunodeficiency Virus."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- positive pregnancy test or breast feeding."}
• {"criterion_text":"- opportunistic infection in the preceding 3 months."}
• {"criterion_text":"- Subjects with current clinical or laboratory evidence of active tuberculosis(TB)."}
• {"criterion_text":"- Subjects with a history of active TB treated within the last 3 years."}
• {"criterion_text":"- Subjects with untreated latent TB"}
• {"criterion_text":"- heavy alcohol consumption (>3 drinks/day)."}
• {"criterion_text":"- liver cirrhosis or severe renal insufficiency."}

Primary endpoints

• {"endpoint_text":"- Depletion of anti-Ro60, anti-Ro52, anti-La and rheumatoid factor B cells in blood, inflamed salivary gland and involved lymph node of patients with SjS at 3 months after initiation of Obinutuzumab compared to sampling before treatment initiation.","definition_or_measurement_approach":"Assessment of depletion of specified B-cell populations in blood, inflamed salivary gland and involved lymph node at 3 months after treatment initiation compared to samples taken before treatment initiation."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in ESSDAI score at Week 12, 24 and 36 (11).","definition_or_measurement_approach":"Change from baseline measured by ESSDAI at Weeks 12, 24 and 36."}
• {"endpoint_text":"- Proportion of patients achieving ≥3 points reduction from baseline in ESSDAIscore at Week 12, 24 and 36.","definition_or_measurement_approach":"Proportion achieving ≥3 point reduction in ESSDAI at Weeks 12, 24 and 36."}
• {"endpoint_text":"- Proportion of patients achieving ESSDAI<5 at Week 12, 24 and 36.","definition_or_measurement_approach":"Proportion of patients with ESSDAI <5 at Weeks 12, 24 and 36."}
• {"endpoint_text":"- Change from baseline in PhGA of disease activity at Week 12, 24 and 36","definition_or_measurement_approach":"Change from baseline in Physician Global Assessment (PhGA) at Weeks 12, 24 and 36."}
• {"endpoint_text":"- Change from baseline in PaGA of disease activity at Week 12, 24 and 36.","definition_or_measurement_approach":"Change from baseline in Patient Global Assessment (PaGA) at Weeks 12, 24 and 36."}
• {"endpoint_text":"- Proportion of patients achieving ≥ 1 point or 15% reduction from baseline in ESSPRI at Week 12, 24 and 36 (11).","definition_or_measurement_approach":"Proportion achieving ≥1 point or 15% reduction in ESSPRI at Weeks 12, 24 and 36."}
• {"endpoint_text":"1. Change from baseline in STAR, Schirmer’s test, unstimulated whole saliva secretion","definition_or_measurement_approach":"Change from baseline in STAR score, Schirmer's test, and unstimulated whole saliva secretion (timepoints not restated beyond the protocol's secondary endpoints listing)."}

Netherlands

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

2

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Radboud universitair medisch centrum Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Roche","duties_or_roles":"Source of monetary support","organisation_type":""}