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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758769
• Other study ID #: IM101-574
• Status: Completed
• Start date: June 7, 2016
• Est. completion date: November 15, 2023

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: November 15, 2023
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• ORENCIA Subcutaneous Injection

Locations

Country	Name	City	State
Japan	Local Institution	Minato-ku	Tokyo
Japan	Mebix, Inc.	Minato-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept		52 Weeks
Secondary	Percentage of achievement in low disease activity by simplified disease activity index (SDAI).		52 Weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls