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

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 Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: ORENCIA Subcutaneous Injection

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Minato-ku, Tokyo, Japan, 1070052
      • Local Institution
    • Minato-ku, Tokyo, Japan, 1070052
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ORENCIA with Exposure	Biological: ORENCIA Subcutaneous Injection; Other Names: Abatacept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept	52 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of achievement in low disease activity by simplified disease activity index (SDAI).	52 Weeks
Change in the percentage of disease activity category by simplified disease activity index(SDAI)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by clinical disease activity index(CDAI)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in simplified disease activity index(SDAI)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in clinical disease activity index(CDAI)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Anti-citrullinated protein antibodies (ACPA)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Rheumatoid factors (RF)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Survival rate	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Hospitalization rate	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Number of occurrences of rheumatoid arthritis related surgery	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Persistence rate of Abatacept treatment	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Reasons for discontinuation of Abatacept treatment	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Japanese Health Assessment Questionnaire	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in European Quality of Life 5 Dimension Questionnaire	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in Pain visual analog scale	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in General visual analog scale	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months
Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56)	0 Months, 1 Month, 6 Months, 12 Months, 18 Months, 24 Months, 30 Months, 36 Months, 42 Months, 48 Months, 54 Months and 60 Months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: April 14, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimated): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): June 22, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Abatacept
• Other Study ID Numbers: IM101-574