臨床研究等提出・公開システム

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogrens Syndrome

A Phase 3 study of Abatacept in Patients with Primary Sjogrens Syndrome

No

Bristol-Myers Squibb K.K.

mg-jp-clinical_trial@bms.com

Bristol-Myers Squibb K.K.

mg-jp-clinical_trial@bms.com

completed

May. 01, 2017

Interventional

Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

treatment purpose

3

Subjects must meet the 2016 ACR/EULAR Classification Criteria for SS (Sjogren's Syndrome), as specified for pSS.
Subjects should have pSS that is refractory to symptomatic or local therapy (e.g. NSAIDs)
Subjects having an ESSDAI score of at least 5 at screening.
Subjects being anti-SS-A/Ro positive at screening.
Stimulated salivary flow of at least 0.1 mL/min at screening and randomization in at least 124 subjects (72%)

Subjects who have a systemic autoimmune disease other than Sjogren's syndrome, such as RA, SLE or systemic sclerosis, that can better explain the majority of the symptoms (ie, secondary Sjogren's syndrome).
Subjects who have another autoimmune disease or inflammatory condition that could interfere with assessment of response of pSS to therapy (eg, systemic sclerosis, inflammatory bowel disease, gout).
Subjects with any other medical condition associated with clinical features overlapping those of pSS or that would interfere with interpretation of results, including but not limited to a history of head and neck radiation treatment, sarcoidosis, amyloidosis, graft-versus-host disease, hepatitis C, acquired immunodeficiency syndrome, and IgG4-related disease.
Active life-threatening or organ-threatening complications of SS disease at the time of screening based on investigator evaluation

Both

Primary Sjogrens Syndrome

investigational material(s)
Generic name etc : Abatacept
INN of investigational material : Abatacept
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Abatacept 125 mg subcutaneous injection once per week

control material(s)
Generic name etc : Abatacept Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Placebo for Abatacept subcutaneous injection once per week

confirmatory
The mean change from baseline (Day 1) in ESSDAI at Day 169.

safety
efficacy
pharmacokinetics
pharmacodynamics
The mean change from baseline in ESSPRI at Day 169
The mean change from baseline in the stimulated whole salivary flow at Day 169 among subjects with stimulated whole salivary flow of at least 0.1 mL/min at both screening and baseline.

Feb. 27, 2017