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 |
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
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
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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