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

Long-Term Outocomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings - Orencia Registry in Geographically Assembled Multicenter Investigation Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021263

Enrollment

300

Registered

2016-03-01

Start date

2016-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all the following criteria (items 1-7) are to be included as patients for this study. 1) Patients with RA who meet the 2010 American College of Rheumatology / European League against Rheumatisms (ACR/EULAR) RA Classification Criteria 2) Patients with RA with a moderate disease activity (SDAI: >11 and <=26) 3) Biologic-naive patients with treatment history >= 1 csDMARDs 4) Patients who meet the following criteria by hematological examination: a) Peripheral white blood cell count: >=4,000/mm3 b) Peripheral lymphocyte count: >=1,000/mm3 c) Blood beta-D-glucan negative 5) Patients >= 20 years of age 6) Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if have 1) Past history of hypersensitivity to the components of the abatacept preparation 2) Complication of a malignant tumor 3) Active infectious disease 4) Hepatitis B and hepatitis B virus carrier (HBs antigen positive) 5) Pregnancy or lactating, or with the possibility of the pregnancy or lactating 6)Been judged by the investigator or the co-investigator as being inappropriate

Design outcomes

Primary

Measure	Time frame
percentage of achievement in SDAI remission after administration of abatacept for 52 weeks	—

Secondary

Measure	Time frame
1) Percentage of achievement in low disease activity by SDAI after 52 weeks 2) The following items during the observation period a) Change in the percentage of disease activity category by SDAI, CDAI, DAS28-ESR and DAS28-CRP; b) Change in SDAI, CDAI, DAS28-ESR, and DAS28-CRP c) Treatment-responsive evaluation by DAS28-ESR, and DAS28-CRP d) Change in J-HAQ score from the baseline and remission rate e) Change in EQ-5D, pain VAS, and general VAS f) Treatment continuation rate and the reason(s) for treatment discontinuation; g) Survival rate h) Serious Adverse Event i) Rate of hospitalization j) Rate of operation caused by rheumatoid arthritis k) Change of ACPA and RF l) Change in PRO parameters	—

Measure

Time frame

1) Percentage of achievement in low disease activity by SDAI after 52 weeks 2) The following items during the observation period a) Change in the percentage of disease activity category by SDAI, CDAI, DAS28-ESR and DAS28-CRP; b) Change in SDAI, CDAI, DAS28-ESR, and DAS28-CRP c) Treatment-responsive evaluation by DAS28-ESR, and DAS28-CRP d) Change in J-HAQ score from the baseline and remission rate e) Change in EQ-5D, pain VAS, and general VAS f) Treatment continuation rate and the reason(s) for treatment discontinuation; g) Survival rate h) Serious Adverse Event i) Rate of hospitalization j) Rate of operation caused by rheumatoid arthritis k) Change of ACPA and RF l) Change in PRO parameters

—

Countries

Japan

Contacts

Public ContactHiroichi Yamamoto

Mebix, Inc. Research promotion division

hiroichi.yamamoto@mebix.co.jp03-4362-4504

Outcome results