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Completed

NCT Number: NCT01625650

Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions: The Corrona CERTAIN Sub-study

The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North America, Inc. is a Sub-study of the CORRONA Data Collection Program.

The CERTAIN Sub-study is designed to systematically collect and document use patterns, effectiveness, comparative effectiveness and safety of biologic agents used in the management of Rheumatoid Arthritis (RA).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Center For Rheumatoligy

Albany, New York, 12159, United States

About this study

Biologic therapies (including biologic medications like Enbrel, Humira, Remicade, Cimzia, Simponi, Actemra, Rituxan and Orencia) have changed the treatment of RA, but the differences in safety and/or effectiveness of each biologic therapy are not all known. We are doing this study in order to try to see if one or more of these treatments are better than the others. The use of databases like the CORRONA Organization database gives us information that helps us to understand why such drugs are used, reasons for starting or stopping drugs, for whom they are prescribed, and to monitor changes in patients' abilities to perform daily activities and gather information on family or social history.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The CORRONA CERTAIN Sub-study is particularly focused on understanding the effectiveness and safety of biologic medications. Male and female patients, who
  • are at least 18 years of age;
  • have a documented diagnosis of RA by their treating rheumatologist;
  • have at least moderate disease activity; and
  • are initiating a biologic agent that has not be used for their treatment in the past are eligible to participate.

Moderate disease activity is defined by a CDAI score greater than 10.

Exclusion criteria

Disease other than RA that do not meet the inclusion criteria

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Collaborators

  • University of Alabama at Birmingham

Registry information

Official study title

The Corrona Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions Sub-study: The Corrona CERTAIN Sub-study

Acronym: CERTAIN

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Jun 21, 2012
Registry last updated
Aug 22, 2018

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.