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Rituximab Treatment in Sjogren's Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00363350
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : February 24, 2009
Hoffmann-La Roche
Information provided by:
University Medical Center Groningen

Brief Summary:
This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Drug: rituximab (anti-CD20) Phase 1 Phase 2

Detailed Description:

Study design:

phase II trial

Study objective:

evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS

Number of participating centres:



follow-up 48 weeks

Study medication:

2 infusions on day 1 and day 15 rituximab infusions (1000 mg) or placebo infusions intravenous infusion of 100 mg of methylprednisolone before infusion of rituximab (or the placebo for rituximab), together with 60 mg per day of oral prednisone on days 2, 3, 16 and 17, 30 mg per day on days 4, 5, 18 and 19 and 15 mg per day on days 6 and 20

Primary objective/endpoint:

stimulated salivary gland function (stimulated submandibular/sublingual and parotid saliva)

Secondary objectives/endpoint:

Functional parameters Laboratory parameters Subjective parameters Histological/Molecular parameters

Number of subjects:

30 patients with primary SS (20 patients rituximab treatment, 10 patients placebo)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial
Study Start Date : August 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Intervention Details:
  • Drug: rituximab (anti-CD20)
    2 infusions of 1000 mg
    Other Name: Mabthera

Primary Outcome Measures :
  1. stimulated whole salivary flow rate [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. Functional parameters [ Time Frame: 48 weeks ]
  2. Laboratory parameters [ Time Frame: 48 weeks ]
  3. Subjective parameters [ Time Frame: 48 weeks ]
  4. Histological/Molecular parameters [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00363350

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University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Hoffmann-La Roche
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Principal Investigator: Jiska Meijer, MD University Medical Center Groningen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: H Bootsma, University Medical Centre Groningen Identifier: NCT00363350    
Other Study ID Numbers: METc2005.229
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents