drugset / Trial / NCT02915159

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

NCT02915159 ↗

Phase 3 Completed 250 enrolled Bristol-Myers Squibb
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2016-12-06
Primary completion
2018-08-07
Completion
2019-07-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Abatacept - Double Blind Treatment Period vs Placebo - Double Blind Treatment Period; p = 0.4421; longitudinal repeated measures analysis NCT02915159 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 125 mg/ml Subcutaneous

Indications