Status:
COMPLETED
Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Primary Sjögren's Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study did evaluate the safety,tolerability and preliminary therapeutic efficacy of multiple doses of intravenous infusion of CFZ533 monoclonal antibody in patients with primary Sjögren's syndrome...
Eligibility Criteria
Inclusion
- Diagnosis of primary Sjögren's syndrome
- ESSDAI score ≥ 6
Exclusion
- Secondary Sjögren's syndrome
- Receiving cyclosphosphamide, corticosteroid bolus with dose over 1 mg/kg, rituximab, belimunab, other immunosuppressives.
- At significant risk for thromboembolic event
- Clinically significant systemic infection
- Significant elevated risk for infection
Key Trial Info
Start Date :
October 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02291029
Start Date
October 22 2014
End Date
June 29 2018
Last Update
January 5 2021
Active Locations (9)
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1
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
2
Novartis Investigative Site
Mineola, New York, United States, 11501
3
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
4
Novartis Investigative Site
Berlin, Germany, 10117