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 |
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)
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
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