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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Orencia

• Registration Number: NCT02600468
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-11-06
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who use ORENCIA	Orencia	Patients who use ORENCIA for the approved indications and who at the start of treatment

Primary Outcome Measures

Name	Time	Method
Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events	3 years

Secondary Outcome Measures

Name	Time	Method
Efficacy measured by Patient's survival	3 years
Efficacy measured by development of malignancies after treatment discontinuation	3 years