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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02291029 |
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Date of registration:
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04/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
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Scientific title:
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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 |
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Date of first enrolment:
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October 22, 2014 |
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Target sample size:
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69 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02291029 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Hungary
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Sjögren's Syndrome
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Intervention(s)
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Drug: CFZ533 active - Cohort 3
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Drug: CFZ533 active - Cohort 2
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Drug: CFZ533 active -Cohort 3
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Drug: CFZ533 placebo - Cohort 2
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Drug: CFZ533 active - Cohort 1
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Drug: CFZ533 placebo- Cohort 1
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Primary Outcome(s)
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Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
[Time Frame: Baseline and Week 12]
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Secondary Outcome(s)
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Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)
[Time Frame: Baseline and Week 12]
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Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score
[Time Frame: Baseline and Week 12]
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Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)
[Time Frame: Baseline and Week 12]
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Change From Baseline in Multidimensional Fatigue Inventory (MFI)
[Time Frame: Baseline and Week 12]
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Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)
[Time Frame: Baseline and Week 12]
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Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score
[Time Frame: Baseline and Week 12]
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Secondary ID(s)
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CCFZ533X2203
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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