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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: ORENCIA Subcutaneous Injection

• Registration Number: NCT02758769
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-14
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• Study Start: 2016-06-07
• Primary Completion: 2019-10-29
• Study Completion: 2023-11-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ORENCIA with Exposure	ORENCIA Subcutaneous Injection	ORENCIA with Exposure

Primary Outcome Measures

Name	Time	Method
Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept	52 Weeks

Secondary Outcome Measures

Name	Time	Method
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
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 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 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 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
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
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
Percentage of achievement in low disease activity by simplified disease activity index (SDAI).	52 Weeks
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 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
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
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 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 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
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 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
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
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

Trial Locations

Locations (2)

Local Institution; 🇯🇵 Minato-ku, Tokyo, Japan

Mebix, Inc.; 🇯🇵 Minato-ku, Tokyo, Japan