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

Sponsor
University of Copenhagen
Study ID
NCT00426543
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2007
Status verified
Mar 2017
Primary completion
Jun 30, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

To investigate the effect of Rituximab on subjective disease symptoms including oral dryness, ocular dryness, myoartralgia and fatigue. [ Time Frame: Baseline, Day 22 after second treatment, 1 month, 3 months and 6 months after treatment. ]

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