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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01625650
• Lead Sponsor: CorEvitas

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-02
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2795

Inclusion Criteria

• The CORRONA CERTAIN Sub-study is particularly focused on understanding the effectiveness and safety of biologic medications. Male and female patients, who

  1. are at least 18 years of age;

  2. have a documented diagnosis of RA by their treating rheumatologist;

  3. have at least moderate disease activity; and

  4. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

The Center For Rheumatoligy; 🇺🇸 Albany, New York, United States