Clinical trial NCT02291029: Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Sjögren's Syndrome
Keywords: Sjögren's syndrome, CFZ533, ESSDAI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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(pSS)


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score
timeFrame: Baseline and Week 12
measure: Change From Baseline in Multidimensional Fatigue Inventory (MFI)
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Mineola
country: United States
facility: Novartis Investigative Site
state: New York
city: Duncansville
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Debrecen
country: Hungary
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Edgbaston
country: United Kingdom
facility: Novartis Investigative Site
state: Birmingham
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: