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NCT03411850 Clinical Trial

Sjogrens Syndrome Measured by Ultrasound

Sjogren's Syndrome Clinical Trial

Official title:
Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03411850
Other study ID # BMS IM101-560
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date May 2016
Est. completion date December 2021

Study information
Verified date May 2021
Source Arthritis & Rheumatism Associates, P.C.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ultrasound study focused on salivary gland outcomes in Sjogren's subjects

Description:

A 32 week ultrasound study for subject diagnosed with Sjogren's Syndrome. Subjects will receive Orencia (Abatacept) as intervention therapy during this trial.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date December 2021
Est. primary completion date May 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Orencia
FDA approved biologic
Other:
• Placebo

Locations
Country Name City State
United States The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C. Wheaton Maryland

Sponsors (2)
Lead Sponsor Collaborator
Arthritis & Rheumatism Associates, P.C. Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Salivary gland changes Salivary gland changes detected by ultrasound imaging with elastography 32 weeks
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