A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Sjogrens Disease

Treatments: Other: Placebo; Biological: Abatacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT02915159

IM101-603

2016-001948-19 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5
• Positive anti-SS-A/Ro antibody at screening
• meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)

Exclusion Criteria:

• Secondary Sjögrens syndrome
• Active life-threatening or organ-threatening complications of Sjögren's-syndrome
• Other medical condition associated with sicca syndrome

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Abatacept

Experimental group

Description:

Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months

Treatment:

Biological: Abatacept

Placebo

Placebo Comparator group

Description:

Placebo for Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months

Treatment:

Biological: Abatacept

Other: Placebo