Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291029
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 4, 2014
First Posted Date  ICMJE November 14, 2014
Results First Submitted Date  ICMJE June 28, 2019
Results First Posted Date  ICMJE August 14, 2019
Last Update Posted Date August 14, 2019
Actual Study Start Date  ICMJE October 22, 2014
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: Baseline and Week 12 ]
The effect of CFZ533 on clinical disease activity was measured by the change in ESSDAI (EULAR Sjögren's syndrome disease activity index) between baseline and week 12. The instrument contains 12 organ-specific domains contributing to disease activity. For each domain, features of disease activity are scored in 3 or 4 levels according to their severity. These scores are then summed across the 12 domains in a weighted manner to provide the total score (range 0-123). A reduction from baseline indicates improvement in patients.
Original Primary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: 12 weeks ]
The changes in an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) after 12 weeks treatment will be analysed and compared between the active treatment and placebo groups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • Change From Baseline in EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) [ Time Frame: Baseline and Week 12 ]
    The ESSPRI is a patient self-reported outcome measure to assess dryness, limb pain, fatigue and mental fatigue, where each of the domains normally reported as 0 (not at all) to 10 (extremely severe). The final ESSPRI score is the average of three: dryness, pain and fatigue. A reduction from baseline indicates the improvement of symptoms.
  • Change From Baseline in Physician Global Assessment of the Patient's Overall Disease Activity (VAS) [ Time Frame: Baseline and Week 12 ]
    The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
  • Change From Baseline in Patient's Global Assessment of Their Disease Activity (VAS) [ Time Frame: Baseline and Week 12 ]
    The visual analogue scale used is a 100 mm VAS ranging from "no disease" (0 mm) to "maximal disease activity" (100 mm).
  • Change From Baseline in Short Form (36) Health Survey (SF-36) Physical Component Score [ Time Frame: Baseline and Week 12 ]
    The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
  • Change From Baseline in Short Form (36) Health Survey (SF-36) Mental Component Score [ Time Frame: Baseline and Week 12 ]
    The SF-36 is a 36-item, patient self-reported outcome measure (questionnaires) of patient health. The outcome of the questionnaires in eight scales results in two summary scores, physical component and mental component, both ranging from 0 - 100. An increase from baseline in either component summary score indicates reduced disease burden.
  • Change From Baseline in Multidimensional Fatigue Inventory (MFI) [ Time Frame: Baseline and Week 12 ]
    The MFI is a patient self-reported outcome measure (questionnaires) to assess fatigue covering the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Each dimension has a possible range from 4-20. The reported total score has a range from 20-100. A reduction from baseline in MFI indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2014)
  • EULAR Sjögren's Syndrome Patient Reported Intensity (ESSPRI) [ Time Frame: 12 weeks ]
    To assess the changes of ESSPRI between baseline and Week 13
  • Physician global assessment of the patient's overall disease activity (VAS) [ Time Frame: 12 weeks ]
    To assess the changes of physician global assessment of the patient's overall disease activity (VAS) between baseline and Week 13
  • Patient's global assessment of their disease activity (VAS) [ Time Frame: 12 weeks ]
    To assess the changes of patient's global assessment of their disease activity (VAS) beween baseline and Week 13
  • Short Form (36) Health Survey (SF-36) [ Time Frame: 12 weeks ]
    To assess the changes of SF-36 between baseline and Week 13
  • Multidimensional Fatigue Inventory (MFI) [ Time Frame: 12 weeks ]
    To assess the changes of MFI between baseline and Week 13
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome
Official Title  ICMJE 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
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Sjögren's Syndrome
Intervention  ICMJE
  • Drug: CFZ533 active - Cohort 1
    multiple doses of CFZ533 s.c. injection
  • Drug: CFZ533 placebo- Cohort 1
    multiple doses of placebo s.c. injection
  • Drug: CFZ533 active - Cohort 2
    multiple doses of CFZ533 intravenous infusion
  • Drug: CFZ533 placebo - Cohort 2
    multiple doses of placebo intravenous infusion
  • Drug: CFZ533 active -Cohort 3
    multiple doses of CFZ533 s.c. injection
  • Drug: CFZ533 active - Cohort 3
    Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
Study Arms  ICMJE
  • Experimental: CFZ533 active- Cohort 2
    multiple doses of CFZ533 intravenous infusion
    Intervention: Drug: CFZ533 active - Cohort 2
  • Placebo Comparator: CFZ533 placebo- Cohort 2
    multiple doses of placebo intravenous infusion
    Intervention: Drug: CFZ533 placebo - Cohort 2
  • Experimental: CFZ533 active - Cohort 1
    multiple doses of CFZ533 s.c. injection
    Intervention: Drug: CFZ533 active - Cohort 1
  • Placebo Comparator: CFZ533 placebo - Cohort 1
    multiple doses of placebo s.c. injection
    Intervention: Drug: CFZ533 placebo- Cohort 1
  • Experimental: CFZ533 Treatment Arm 1 - Cohort 3
    multiple doses of CFZ533 s.c. injection
    Intervention: Drug: CFZ533 active -Cohort 3
  • Experimental: CFZ533 Treatment Arm 2 - Cohort 3
    Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
    Intervention: Drug: CFZ533 active - Cohort 3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2019)
69
Original Estimated Enrollment  ICMJE
 (submitted: November 11, 2014)
30
Actual Study Completion Date  ICMJE June 29, 2018
Actual Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Hungary,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291029
Other Study ID Numbers  ICMJE CCFZ533X2203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP