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

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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 )

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)

Condition or disease Intervention/treatment Phase
Primary Sjögren's Syndrome Drug: CFZ533 active - Cohort 1 Drug: CFZ533 placebo- Cohort 1 Drug: CFZ533 active - Cohort 2 Drug: CFZ533 placebo - Cohort 2 Drug: CFZ533 active -Cohort 3 Drug: CFZ533 active - Cohort 3 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 22, 2014
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CFZ533 active- Cohort 2
multiple doses of CFZ533 intravenous infusion
Drug: CFZ533 active - Cohort 2
multiple doses of CFZ533 intravenous infusion

Placebo Comparator: CFZ533 placebo- Cohort 2
multiple doses of placebo intravenous infusion
Drug: CFZ533 placebo - Cohort 2
multiple doses of placebo intravenous infusion

Experimental: CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection
Drug: CFZ533 active - Cohort 1
multiple doses of CFZ533 s.c. injection

Placebo Comparator: CFZ533 placebo - Cohort 1
multiple doses of placebo s.c. injection
Drug: CFZ533 placebo- Cohort 1
multiple doses of placebo s.c. injection

Experimental: CFZ533 Treatment Arm 1 - Cohort 3
multiple doses of CFZ533 s.c. injection
Drug: CFZ533 active -Cohort 3
multiple doses of CFZ533 s.c. injection

Experimental: CFZ533 Treatment Arm 2 - Cohort 3
Single dose of CFZ533 i.v. infusion and 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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291029


Locations
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United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02111
United States, New York
Novartis Investigative Site
Mineola, New York, United States, 11501
United States, Pennsylvania
Novartis Investigative Site
Duncansville, Pennsylvania, United States, 16635
Germany
Novartis Investigative Site
Berlin, Germany, 10117
Hungary
Novartis Investigative Site
Debrecen, Hungary, 4032
Switzerland
Novartis Investigative Site
Basel, Switzerland, 4031
United Kingdom
Novartis Investigative Site
Edgbaston, Birmingham, United Kingdom, B15 2WB
Novartis Investigative Site
London, United Kingdom, EC14 7BE
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom, NE2 4HH
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] May 24, 2017
Statistical Analysis Plan  [PDF] September 5, 2018


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02291029     History of Changes
Other Study ID Numbers: CCFZ533X2203
First Posted: November 14, 2014    Key Record Dates
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019
Last Verified: July 2019

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sjögren's syndrome, CFZ533, ESSDAI

Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs