Sjogrens Syndrome Measured by Ultrasound

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2021-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Sjogren's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Orencia (Abatacept)

Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection

Group Type ACTIVE_COMPARATOR

Orencia

Intervention Type BIOLOGICAL

FDA approved biologic

Placebo

Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Orencia

FDA approved biologic

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Other Intervention Names

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Abatacept Saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes