Rituximab Treatment in Sjogren's Syndrome

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00363350
First received: August 10, 2006
Last updated: February 23, 2009
Last verified: February 2009
  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:


Further study details as provided by University Medical Centre 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:
    Drug: rituximab (anti-CD20)
    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
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
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 Centre Groningen
Hoffmann-La Roche
Investigators
Principal Investigator: Jiska Meijer, MD University Medical Centre Groningen
  More Information

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

Additional relevant MeSH terms:
Sjogren's Syndrome
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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 16, 2014