Back to resultsSjogrens Syndrome Measured by Ultrasound
Primary Purpose
Sjogren's Syndrome
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Orencia
Placebo
Sponsored by
About this trial
This is an interventional other trial for Sjogren's Syndrome
Eligibility 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
Sites / Locations
- The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Orencia (Abatacept)
Placebo
Arm Description
Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection
Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)
Outcomes
Primary Outcome Measures
Salivary gland changes
Salivary gland changes detected by ultrasound imaging with elastography
Secondary Outcome Measures
Full Information
NCT ID
NCT03411850
First Posted
June 30, 2016
Last Updated
May 10, 2021
Sponsor
Arthritis & Rheumatism Associates, P.C.
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03411850
Brief Title
Sjogrens Syndrome Measured by Ultrasound
Official Title
Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arthritis & Rheumatism Associates, P.C.
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ultrasound study focused on salivary gland outcomes in Sjogren's subjects
Detailed Description
A 32 week ultrasound study for subject diagnosed with Sjogren's Syndrome. Subjects will receive Orencia (Abatacept) as intervention therapy during this trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orencia (Abatacept)
Arm Type
Active Comparator
Arm Description
Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)
Intervention Type
Biological
Intervention Name(s)
Orencia
Other Intervention Name(s)
Abatacept
Intervention Description
FDA approved biologic
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Salivary gland changes
Description
Salivary gland changes detected by ultrasound imaging with elastography
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Sjogrens Syndrome Measured by Ultrasound
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