Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Rheumatoid Arthritis Clinical Trial

Official title:

Outline of Survey on Long-Term Use of ORENCIA® Intravenous Infusion 250mg

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02600468
• Other study ID #: IM101-516
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: January 13, 2017
• Start date: September 2013
• Est. completion date: December 2015

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 serious infections and malignancies, and efficacy of the long-term use of ORENCIA Intravenous Infusion 250mg in patients with rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• 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 Intravenous Infusion 250mg under the approved indications, dosage, and administration

• Have available HAQ data

• Have available DAS28-ESR or DAS28- CRP data

• Have no past or present history of malignancies

• Are expected to be followed up for 3 years

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Orencia

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events		3 years
Secondary	Efficacy measured by Patient's survival		3 years
Secondary	Efficacy measured by development of malignancies after treatment discontinuation		3 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form