Post-Marketing Surveillance Studies

Disease Area:
Juvenile Idiopathic Arthritis (JIA)

Biosample Status:
No Biosample

Drug Safety Monitoring Studies

Post-marketing surveillance studies are studies that are required or agreed to by pharmaceutical companies after regulatory agencies, like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), approve a treatment for use by patients.

It is impossible to have complete information about the safety and effectiveness of a drug at the time of approval, which is why it is important to see what happens to patients who are on certain treatments over the months and even years that a product is available for use.

Outcomes related to the drug are monitored after the treatment reaches the market and clinical trials are completed. Surveillance studies evaluate drugs taken by individuals under a wide range of circumstances and over an extended period of time. Regulatory agencies review reports of problems with drugs and can decide to add cautions to the dosage or usage information, as well as other measures for more serious issues.

Researchers and agencies want to learn:

• If certain treatments are associated with safety concerns that were not identified at the time of drug approval
• If there are other concerns or opportunities to improve treatments, based on patient experience
• CARRA is specifically studying outcomes related to:
  • Canakinumab, for treatment of systemic JIA (sJIA)
  • Tocilizumab, for treatment of polyarticular JIA (pJIA)
  • Tofacitinib, for treatment of polyarticular JIA (pJIA)

The CARRA Registry was created to monitor the long-term safety of the medications used to treat pediatric rheumatic diseases. It is fully compliant with FDA regulations (21 CFR Part 11 compliant), and CARRA intends to collect data on enrolled participants on a regular basis for at least 10 years. Standard processes are in place to collect, monitor, validate and analyze Registry data to identify possible safety issues in real-time.

Study Updates and Findings

These programs are ongoing and do not have public findings at this time.

About the Participants

• Enrolled or eligible to join the CARRA Registry. The CARRA Registry was designed to easily support post-marketing studies without extra effort from Registry participants. Data such as medication history, adverse events and other characteristics, are collected and reviewed on an ongoing basis.

About the Study Team

CARRA works with several pharmaceutical partners to understand their post-marketing study requirements and ensure data are available from the Registry to support their needs. Learn more about how CARRA engages with industry partners.