Sjogrens Syndrome Measured by Ultrasound

Arthritis & Rheumatism Associates, P.C.

Status and phase: Unknown; Phase 2

Conditions: Sjogren's Syndrome

Treatments: Biological: Orencia; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03411850

BMS IM101-560

Details and patient eligibility

About

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

Full description

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

Orencia (Abatacept)

Active Comparator group

Description:

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

Treatment:

Biological: Orencia

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo