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

• Register: ClinicalTrials.gov
• Last refreshed on: 27 September 2021
• Main ID: NCT02758769
• Date of registration: 14/04/2016
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
• Scientific title: Long-Term Outcomes With Abatacept In Biologic Treatment-Naive Rheumatoid Arthritis Patients In Japanese Clinical Practice Settings
• Date of first enrolment: June 7, 2016
• Target sample size: 303
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02758769
• Study type: Observational

Countries of recruitment

Japan

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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 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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: ORENCIA Subcutaneous Injection

Primary Outcome(s)

Percentage of achievement in simplified disease activity index (SDAI) remission after administration of abatacept [Time Frame: 52 Weeks]

Secondary Outcome(s)

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Percentage of achievement in low disease activity by simplified disease activity index (SDAI). [Time Frame: 52 Weeks]

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]

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]

Secondary ID(s)

IM101-574

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ono Pharmaceutical Co. Ltd