Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome



Status:Completed
Conditions:Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:12/13/2018
Start Date:October 22, 2014
End Date:June 29, 2018

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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's Syndrome

This study will 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(pSS)


Inclusion Criteria:

- Diagnosis of primary Sjögren's syndrome

- ESSDAI score ≥ 6

Exclusion Criteria:

- 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
We found this trial at
4
sites
Mineola, New York 11501
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Mineola, NY
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Berlin,
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Boston, Massachusetts 02118
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from
Boston, MA
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Duncansville, Pennsylvania 16635
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from
Duncansville, PA
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