Korean Post-marketing Surveillance for Orencia®

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: No Intervention (subjects were previously treated with Orencia®)

Study type: Observational

Funder types: Industry

Identifiers

NCT01583244

IM101-300

Details and patient eligibility

About

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Orencia® so that the regulatory authority can manage the marketing approval properly.

Full description

Time Perspective: Prospective / Retrospective(On-treatment)

Enrollment: 701 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Patients must be diagnosed with: Adult Rheumatoid arthritis (RA): adult patients with moderate-to-severe active RA

Or

• Juvenile idiopathic RA: juvenile patients aged 6 years and older with moderate-to-severe active RA

Exclusion Criteria:

• Children aged <6 years
• Pregnant or lactating women
• Patients who are participating in another study
• Patients known to be hypersensitive to the active component of the surveillance drug or any other component of the surveillance drug
• Patients who had a positive tuberculosis screening test but were not treated with standard therapy before participating in the study
• Patients who have a positive hepatitis virus test
• Patients who were given a live vaccine concurrently with the surveillance drug or are expected to be given a live vaccine again within 3 months after discontinuation of the surveillance drug

Trial design

701 participants in 1 patient group

Patients with active rheumatoid arthritis

Description:

Patients aged 6 years and over who have moderate-to-severe active rheumatoid arthritis

Treatment:

Drug: No Intervention (subjects were previously treated with Orencia®)