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Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome

NCT00426543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-03-14

No results posted yet for this study

Summary

The primary purpose of the study is to determine whether B-cell depletion with Rituximab has an effect on the oral, ocular and general disease manifestations in patients with primary Sjögren´s syndrome, that is, an effect on the symptoms of oral and ocular dryness, improvement of the glandular function and a beneficial effect on the general symptoms such as fatigue. The secondary purpose of the study is the investigate the underlying autoimmune and pathophysiological mechanisms in Sjögren´s syndrome.

Conditions

  • Primary Sjögren's Syndrome
  • Xerostomia
  • Hyposalivation
  • Keratoconjunctivitis Sicca
  • Fatigue

Interventions

DRUG

MabThera (rituximab)

1000 mg infusion twice with 14 days interval

DRUG

Rituximab, Mabthera

1000 mg Rituximab infusion in 500 ml isotonic sodiumchloride twice with 14 days interval

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Anne Marie Lynge Pedersen, PhD, DDS · Institute of Odontology, Faculty of Health Sciences, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2010-06-30
Completion
2010-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00426543 on ClinicalTrials.gov