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

  • STATUS
    Recruiting
  • sponsor
    Novartis Pharmaceuticals
Updated on 25 March 2021

Summary

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

Description

Winthrop University Hospital Clinical Trials Center in conjunction with The Division of Rheumatology and The Arthritis and Rheumatic Disease Center is conducting a clinical research study on an investigational medication, for patient with dry mouth associated with SjÖgren’s Syndrome.

This study will evaluate the safety and effectiveness of an investigational drug, used for dry mouth associated with SjÖgren’s Syndrome. This study should enhance hydration and relieve the symptoms of dry mouth.

Eligible participants will receive study-related medical care, research medication and laboratory procedures at no cost, while you are participating in this research study. Compensation may be provided for time and travel.

Details
Condition Sjogren's Syndrome, Rheumatoid Arthritis
Clinical Study IdentifierTX153301
SponsorNovartis Pharmaceuticals
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

To be eligible for the study, you must
Be at between 18 to 75 years of age
Have been diagnosed with SjÖgren’s Syndrome
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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