Rituximab Treatment in Sjogren's Syndrome

Study Description

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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:

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 Design

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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

Arms and Interventions

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Intervention Details:

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

Outcome Measures

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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 ]

Eligibility Criteria

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

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

Contacts and Locations

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Locations

Netherlands
University Medical Centre Groningen
Groningen, Netherlands, 9700 RB

Sponsors and Collaborators

University Medical Center Groningen

Hoffmann-La Roche

Investigators

Principal Investigator:	Jiska Meijer, MD	University Medical Center Groningen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Pijpe J, van Imhoff GW, Spijkervet FK, Roodenburg JL, Wolbink GJ, Mansour K, Vissink A, Kallenberg CG, Bootsma H. Rituximab treatment in patients with primary Sjögren's syndrome: an open-label phase II study. Arthritis Rheum. 2005 Sep;52(9):2740-50.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Meijer JM, Meiners PM, Vissink A, Spijkervet FK, Abdulahad W, Kamminga N, Brouwer E, Kallenberg CG, Bootsma H. Effectiveness of rituximab treatment in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Apr;62(4):960-8. doi: 10.1002/art.27314.

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
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