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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Biological: ORENCIA Subcutaneous Injection

Study type: Observational

Funder types: Industry

Identifiers

NCT02758769

IM101-574

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

303 participants in 1 patient group

ORENCIA with Exposure

Description:

ORENCIA with Exposure

Treatment:

Biological: ORENCIA Subcutaneous Injection