Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)



Status:Recruiting
Conditions:Rheumatology
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:1/11/2019
Start Date:June 27, 2017
End Date:June 30, 2020
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)

This study will determine the dose-response relationship of VAY736 for key efficacy and
safety parameters


Inclusion Criteria:

- Fulfilled revised American European Consensus Group criteria for pSS

- Seropositive at screening for anti-Ro/SSA antibodies

- Screening ESSDAI value >=6 scored from 7 domains: articular, cutaneous, glandular,
lymphoadenopathy, constitutional, biologic and hematologic.

Exclusion Criteria:

- Secondary Sjogren's syndrome

- Use of other investigational drugs

- Active viral, bacterial or other infections

- Positive hepatitis B, hepatitis C, HIV or tuberculosis test results at screening
We found this trial at
14
sites
Baltimore, Maryland 21287
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Boca Raton, Florida 33486
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Boston, Massachusetts 02118
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Boston, MA
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Charleston, South Carolina 29407
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Ciudad Autonoma de Bs As, Buenos Aires
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Houston, Texas 77030
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Indianapolis, Indiana 46202
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Indianapolis, IN
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Jacksonville, Florida 32216
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Jacksonville, FL
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Plantation, Florida 33324
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Plantation, FL
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Rochester, New York 14615
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Rochester, NY
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San Antonio, Texas 78207
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Wexford, Pennsylvania 15090
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Wexford, PA
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