Rheumatoid Arthritis Clinical Trial
Official title:
Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
NCT number | NCT02758769 |
Other study ID # | IM101-574 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 7, 2016 |
Est. completion date | November 15, 2023 |
Verified date | May 2024 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Japan | Local Institution | Minato-ku | Tokyo |
Japan | Mebix, Inc. | Minato-ku | Tokyo |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
Japan,
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 |
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