Anti-CD20 for the retreatment of primary Sjögren*s syndrome in patients who were included in the placebo-controlled double blinded rituximab study

Phase 2

Not yet recruiting

• Conditions: Sjogren's syndrome; 10003816

• Registration Number: NL-OMON32498
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

* Stimulated whole saliva secretion >= 0,15 ml/min
* Male or female of 18 years or older
* Primary SS according to the revised European - U.S. criteria(22)
* Positive autoantibodies (IgM-Rf *10 and SS-A and/or SS-B)
* Parotid gland biopsy (paraffin material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 24 months ago)
* Use of reliable method of contraception during the first 48 weeks of the study
* Written informed consent

Exclusion Criteria

* The presence of any other connective tissue disease
* Preceding treatment with anti-TNF or other monoclonal antibodies than rituximab
* Use of prednisone, hydroxychloroquine less than 1 month ago
* Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than * year ago
* Serum creatine > 2.8 mg/dl (250 *mol/l)
* ASAT or ALAT outside 1.5 x upper normal range of the laboratory
* Hb < 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females
* Neutrophil granulocytes less than 0.5 x 109/l
* Platelet count less then 50 x 109/l
* Positive pregnancy test or breast-feeding
* History of alcohol or drug abuse
* Serious infections
* Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study
* History of any malignancy with the exception of completely resected basal cell carcinoma of the skin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Stimulated salivary gland function (stimulated submandibular / sublingual and<br /><br>parotid saliva)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Functional parameters<br /><br>* Laboratory parameters<br /><br>* Subjective parameters<br /><br>* Histological/Molecular parameters</p><br>