Rituximab Treatment in Sjogren's Syndrome
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ClinicalTrials.gov Identifier: NCT00363350 |
Recruitment Status
:
Completed
First Posted
: August 15, 2006
Last Update Posted
: February 24, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sjogren's Syndrome | Drug: rituximab (anti-CD20) | Phase 1 Phase 2 |
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:
1
Duration:
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)
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 |

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Drug: rituximab (anti-CD20)
- stimulated whole salivary flow rate [ Time Frame: 48 weeks ]
- Functional parameters [ Time Frame: 48 weeks ]
- Laboratory parameters [ Time Frame: 48 weeks ]
- Subjective parameters [ Time Frame: 48 weeks ]
- Histological/Molecular parameters [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00363350
Netherlands | |
University Medical Centre Groningen | |
Groningen, Netherlands, 9700 RB |
Principal Investigator: | Jiska Meijer, MD | University Medical Center Groningen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | H Bootsma, University Medical Centre Groningen |
ClinicalTrials.gov Identifier: | NCT00363350 History of Changes |
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:
Syndrome Sjogren's Syndrome Disease Pathologic Processes Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia Salivary Gland Diseases Mouth Diseases |
Stomatognathic Diseases Dry Eye Syndromes Lacrimal Apparatus Diseases Eye Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Rituximab Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |