Rituximab Treatment in Sjogren's Syndrome - Full Text View

Purpose

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	Intervention	Phase
Sjogren's Syndrome	Drug: rituximab (anti-CD20)	Phase 1 Phase 2


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

Resource links provided by NLM:

Genetics Home Reference related topics: Sjögren syndrome

MedlinePlus related topics: Sjogren's Syndrome

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:

stimulated whole salivary flow rate [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional parameters [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Laboratory parameters [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Subjective parameters [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Histological/Molecular parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	30
Study Start Date:	August 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

2 infusions of 1000 mg

Other Name: Mabthera

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)

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363350

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

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
Study First Received:	August 10, 2006
Last Updated:	February 23, 2009
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on September 30, 2016