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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600455
• Other study ID #: IM101-515
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: January 12, 2017
• Start date: September 2013
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Orencia

Locations

Country	Name	City	State
Japan	Local Institution	Shinjuku-ku	Tokyo

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events		24 weeks

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form