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OpenTrials
Completed

NCT Number: NCT02291029

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

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)

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Key information

Conditions

Primary Sjögren's Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CFZ533 active - Cohort 1

Drug

multiple doses of CFZ533 s.c. injection

CFZ533 placebo- Cohort 1

Drug

multiple doses of placebo s.c. injection

CFZ533 active - Cohort 2

Drug

multiple doses of CFZ533 intravenous infusion

CFZ533 placebo - Cohort 2

Drug

multiple doses of placebo intravenous infusion

CFZ533 active -Cohort 3

Drug

multiple doses of CFZ533 s.c. injection

CFZ533 active - Cohort 3

Drug

Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2014
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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