NCT00363350

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

2.2 years

First QC Date

August 10, 2006

Last Update Submit

February 23, 2009

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

  • stimulated whole salivary flow rate

    48 weeks

Secondary Outcomes (4)

  • Functional parameters

    48 weeks

  • Laboratory parameters

    48 weeks

  • Subjective parameters

    48 weeks

  • Histological/Molecular parameters

    12 weeks

Interventions

rituximab (anti-CD20)DRUG

2 infusions of 1000 mg

Also known as: Mabthera

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • Use of reliable method of contraception during the study
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Groningen

Groningen, Provincie Groningen, 9700 RB, Netherlands

Location

Related Publications (2)

  • 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 Sjogren's syndrome: an open-label phase II study. Arthritis Rheum. 2005 Sep;52(9):2740-50. doi: 10.1002/art.21260.

    PMID: 16142737BACKGROUND

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

    PMID: 20131246DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jiska Meijer, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

NL(1)