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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orencia

Drug

Primary outcomes

Safety measured by number of Adverse events and laboratory abnormalities associated with adverse events

Time frame: 3 years

Secondary outcomes

Efficacy measured by Patient's survival

Time frame: 3 years
Efficacy measured by development of malignancies after treatment discontinuation

Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Nov 9, 2015
Registry last updated: Jan 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed