Sjogrens Syndrome Measured by Ultrasound

Phase 2

• Conditions: Sjogren's Syndrome
• Interventions: Other: Placebo; Biological: Orencia

• Registration Number: NCT03411850
• Lead Sponsor: Arthritis & Rheumatism Associates, P.C.

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-26
• Status Verified: 2021-05
• Primary Completion: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Subjects diagnosed with Sjogren's Syndrome

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)
Orencia (Abatacept)	Orencia	Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection

Primary Outcome Measures

Name	Time	Method
Salivary gland changes	32 weeks	Salivary gland changes detected by ultrasound imaging with elastography

Trial Locations

Locations (1)

The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.; 🇺🇸 Wheaton, Maryland, United States