Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment orencia
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharmaceutical Co. Ltd
Start date September 2013
End date September 2016
Trial size 370 participants
Trial identifier NCT02600455, IM101-515

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients who are treated with ORENCIA according to the approved indications, and dosage and administration
orencia

Primary Outcomes

Measure
Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events
time frame: 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Outline of Use-Results Survey for ORENCIA® Subcutaneous Injection 125mg Syringe 1mL
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.