NCT03466814

Brief Summary

Observational study of abatacept in the treatment of JIA in Japan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

April 6, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

June 16, 2022

Status Verified

June 1, 2022

Enrollment Period

3.3 years

First QC Date

March 9, 2018

Last Update Submit

June 15, 2022

Conditions

Undifferentiated Arthritis

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events

    1 year

Secondary Outcomes (2)

  • Safety measured by number of participants who receive at least 1 dose of Orencia

    1 year

  • Efficacy measured by number of participants who receive at least 1 dose of Orencia

    1 Year

Study Arms (1)

JIA participants

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

JIA participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study is a local, prospective, non-interventional, non-controlled, multicenter, observational study for authorization of abatacept in the treatment of JIA

You may qualify if:

  • All JIA participants who initiate treatment with Orencia in accordance with the prescribing information

You may not qualify if:

  • Participants receiving Orencia for an off-label indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Shinjuku-ku, Tokyo, 162-0822, Japan

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 15, 2018

Study Start

April 6, 2018

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

June 16, 2022

Record last verified: 2022-06

Locations

JP(1)