Rituximab Treatment in Sjogren's Syndrome

Sjogren's Syndrome Clinical Trial

Official title:

Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00363350
• Other study ID #: METc2005.229
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 10, 2006
• Last updated: February 23, 2009
• Start date: August 2006
• Est. completion date: October 2008

Study information

• Verified date: February 2009
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• rituximab (anti-CD20)
2 infusions of 1000 mg

Locations

Country	Name	City	State
Netherlands	University Medical Centre Groningen	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Hoffmann-La Roche

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stimulated whole salivary flow rate		48 weeks	No
Secondary	Functional parameters		48 weeks	No
Secondary	Laboratory parameters		48 weeks	No
Secondary	Subjective parameters		48 weeks	No
Secondary	Histological/Molecular parameters		12 weeks	No