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Completed

NCT Number: NCT02758769

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Minato-ku, Tokyo, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORENCIA Subcutaneous Injection

Biological

Other names: Abatacept

Primary outcomes

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

    Time frame: 52 Weeks

Secondary outcomes

  1. Percentage of achievement in low disease activity by simplified disease activity index (SDAI).

    Time frame: 52 Weeks

  2. Change in the percentage of disease activity category by simplified disease activity index(SDAI)

    Time frame: 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

  3. Change in the percentage of disease activity category by clinical disease activity index(CDAI)

    Time frame: 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

  4. Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)

    Time frame: 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

  5. Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)

    Time frame: 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

  6. Change in simplified disease activity index(SDAI)

    Time frame: 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

  7. Change in clinical disease activity index(CDAI)

    Time frame: 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

  8. Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)

    Time frame: 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

  9. Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP)

    Time frame: 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

  10. Change in Anti-citrullinated protein antibodies (ACPA)

    Time frame: 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

  11. Change in Rheumatoid factors (RF)

    Time frame: 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

  12. Survival rate

    Time frame: 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

  13. Hospitalization rate

    Time frame: 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

  14. Number of occurrences of rheumatoid arthritis related surgery

    Time frame: 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

  15. Persistence rate of Abatacept treatment

    Time frame: 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

  16. Reasons for discontinuation of Abatacept treatment

    Time frame: 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

  17. Change in Japanese Health Assessment Questionnaire

    Time frame: 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

  18. Change in European Quality of Life 5 Dimension Questionnaire

    Time frame: 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

  19. Change in Pain visual analog scale

    Time frame: 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

  20. Change in General visual analog scale

    Time frame: 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

  21. Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
May 2, 2016
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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