Rheumatoid Arthritis
Conditions
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.
Interventions
BIOLOGICALORENCIA Subcutaneous Injection
Sponsors
Ono Pharmaceutical Co. Ltd
Bristol-Myers Squibb
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept | 52 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 - 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 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 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 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 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 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 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 |
| Percentage of achievement in low disease activity by simplified disease activity index (SDAI). | 52 Weeks |
| 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 |
| 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 |
| 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 |
| 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 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 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 |
| 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 |
| 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 |
Countries
Japan
Outcome results
None listed