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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 24 May 2021
Main ID:  NCT03411850
Date of registration: 30/06/2016
Prospective Registration: No
Primary sponsor: Arthritis & Rheumatism Associates, P.C.
Public title: Sjogrens Syndrome Measured by Ultrasound
Scientific title: Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study
Date of first enrolment: May 2016
Target sample size: 20
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03411850
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Participant).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects diagnosed with Sjogren's Syndrome

Exclusion Criteria:

- Subjects previously diagnosed with Sarcoidsis

- Subjects with positive for Hepatitis B, Hepatitis C, HIV

- Subjects diagnosed with Cancer within 5 years of screening



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Sjogren's Syndrome
Intervention(s)
Biological: Orencia
Other: Placebo
Primary Outcome(s)
Salivary gland changes [Time Frame: 32 weeks]
Secondary Outcome(s)
Secondary ID(s)
BMS IM101-560
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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