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

Rheumatoid Arthritis Clinical Trial

— CERTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625650
• Other study ID #: New England IRB 02-021
• Secondary ID: NEIRB 02-021
• Status: Completed
• Start date: October 2010
• Est. completion date: May 2015

Study information

• Verified date: February 2016
• Source: Corrona, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2795
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	The Center For Rheumatoligy	Albany	New York

Sponsors (2)

Lead Sponsor	Collaborator
Corrona, LLC.	University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

External Links

•   CORRONA Inc. Web site