Clinical trial NCT02758769: Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Official title: Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-05-02
Enrollment: 303
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept
timeFrame: 52 Weeks
Secondary outcomes:
measure: Percentage of achievement in low disease activity by simplified disease activity index (SDAI).
timeFrame: 52 Weeks
measure: Change in the percentage of disease activity category by simplified disease activity index(SDAI)
timeFrame: 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
measure: Change in the percentage of disease activity category by clinical disease activity index(CDAI)
timeFrame: 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
measure: Change in the percentage of disease activity category by disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: 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
measure: Change in the percentage of disease activity category by disease activity score with 28 joint counts creactive protein (DAS28-CRP)
timeFrame: 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
measure: Change in simplified disease activity index(SDAI)
timeFrame: 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
measure: Change in clinical disease activity index(CDAI)
timeFrame: 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
measure: Change in disease activity score with 28 joint counts - erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: 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
measure: Change in disease activity score with 28 joint counts Creactive protein (DAS28-CRP)
timeFrame: 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
measure: Change in Anti-citrullinated protein antibodies (ACPA)
timeFrame: 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
measure: Change in Rheumatoid factors (RF)
timeFrame: 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
measure: Survival rate
timeFrame: 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
measure: Hospitalization rate
timeFrame: 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
measure: Number of occurrences of rheumatoid arthritis related surgery
timeFrame: 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
measure: Persistence rate of Abatacept treatment
timeFrame: 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
measure: Reasons for discontinuation of Abatacept treatment
timeFrame: 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
measure: Change in Japanese Health Assessment Questionnaire
timeFrame: 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
measure: Change in European Quality of Life 5 Dimension Questionnaire
timeFrame: 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
measure: Change in Pain visual analog scale
timeFrame: 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
measure: Change in General visual analog scale
timeFrame: 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
measure: Change in PRO parameters defined in IORRA registry (JMAJ 2009 52 (1) 54-56)
timeFrame: 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
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Minato-ku
country: Japan
facility: Mebix, Inc.
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: