Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings

Bristol-Myers Squibb303 enrolled

Overview

The purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.

Study Type

OBSERVATIONAL

Enrollment

303

Conditions

Rheumatoid Arthritis

Interventions

ORENCIA Subcutaneous InjectionBIOLOGICAL

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria * Patients with RA with a moderate disease activity (SDAI: \> 11 and 26) * Biologic-naive patients with treatment history csDMARDs * Patients who meet the following criteria by hematological examination: * Peripheral white blood cell count: 4,000/mm3 * Peripheral lymphocyte count: 1,000/mm3 * Blood β-D-glucan negative * Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study * Patients initiated with abatacept at per their physician's therapeutic decision Exclusion Criteria: * Past history of hypersensitivity to the components of the abatacept preparation * Disease complications from a comorbidity * Active infectious disease * Been judged by the investigator or the co-investigator as being inappropriate Other protocol defined inclusion/exclusion criteria could apply

Locations (2)

Local Institution - 0001

Minato-ku, Tokyo, Japan

Local Institution

Minato-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept

Time frame: 52 Weeks