Rituximab Treatment in Sjogren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00363350
• Date of registration: 10/08/2006
• Prospective Registration: No
• Primary sponsor: University Medical Centre Groningen
• Public title: Rituximab Treatment in Sjogren's Syndrome
• Scientific title: Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial
• Date of first enrolment: August 2006
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00363350
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

Netherlands

Contacts

• Name: Jiska Meijer, MD
• Affiliation: University Medical Centre Groningen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Stimulated whole saliva secretion = 0,15 ml/min

- Male or female > 18 years

- 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 (paraffine material and fresh frozen tissue) with characteristic
features of SS performed at time of inclusion (no longer than 12 months ago)

- Use of reliable method of contraception during the study

- Written informed consent

Exclusion Criteria:

- The presence of any other connective tissue disease

- Preceding treatment with anti-TNF or other monoclonal antibodies

- Use of prednisone, hydroxychloroquine less than 1 month ago

- Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than
0,5 year ago

- Serum creatine > 2.8 mg/dl (250 micromol/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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Intervention(s)

Drug: rituximab (anti-CD20)

Primary Outcome(s)

stimulated whole salivary flow rate [Time Frame: 48 weeks]

Secondary Outcome(s)

Subjective parameters [Time Frame: 48 weeks]

Laboratory parameters [Time Frame: 48 weeks]

Functional parameters [Time Frame: 48 weeks]

Histological/Molecular parameters [Time Frame: 12 weeks]

Secondary ID(s)

METc2005.229

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche