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CompletedNCT02600455Updated Jan 13, 2017

Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL

An observational study in Rheumatoid Arthritis, sponsored by Bristol-Myers Squibb. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-13.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
505
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study to collect information on the safety, especially localized injection site reactions, and efficacy of ORENCIA Subcutaneous Injection 125mg Syringe 1mL in patients with rheumatoid arthritis.

02

Conditions studied

  • Rheumatoid Arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 505 is above the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients who are treated with ORENCIA according to the approved indications, and dosage and administration.

Eligibility criteria

Inclusion Criteria:

  • Patients who are beginning to receive the treatment with ORENCIA Subcutaneous Injection 125mg Syringe 1mL under the approved indications, dosage, and administration
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
505 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients who are treated with ORENCIA

    Patients who are treated with ORENCIA according to the approved indications, and dosage and administration

    Drug: Orencia

Interventions

  • DrugOrencia
06

What researchers measure

Primary outcomes

  1. Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events

    Time frame: 24 weeks

07

Study locations

1 site
  • Local Institution
    Shinjuku-ku, Tokyo 162-0822, Japan
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02600455
Lead sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Nov 9, 2015
Start date
Sep 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jan 13, 2017

Study contacts

Bristol Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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