Efficacy of B-cell depletion with rituximab on oral, ocular and general disease manifestations in patients with primary Sjögren disease
Active, not recruiting
- Conditions
- Previously treated patients with primary Sjögrens diseaseMedDRA version: 8.0Level: PTClassification code 10040767
- Registration Number
- EUCTR2005-004740-31-DK
- Lead Sponsor
- niversity of Copenhagen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Female
- Target Recruitment
- 34
Inclusion Criteria
Female patients with primary Sjögrens disease
Age 18-60 year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnancy and lactation
Systemic treatment with cytostatics
Previous rituximab treatment
Active infection that requires antibiotic treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Treatment efficacy on Sjögrens disease;Secondary Objective: Structural changes from glandula parotis, efficacy on glandula function.<br>Efficacy on glandula function<br>Efficacy on circulating serum autoantibodies.<br>Safety;Primary end point(s): Subjective disease manifestations defined as dryness of mouth and eyes, muscle- and synovial pain and tiredness
- Secondary Outcome Measures
Name Time Method