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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Orencia

• Registration Number: NCT02600455
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

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: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

Inclusion Criteria

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

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

Primary Outcome Measures

Name	Time	Method
Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events	24 weeks

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Shinjuku-ku, Tokyo, Japan