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).
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||1 Year|
|Official Title:||The Corrona Effectiveness Registry to Study Therapies for Arthritis and Inflammatory Conditions Sub-study: The Corrona CERTAIN Sub-study|
Blood tests: at each study blood is obtained to examine, lipid levels with direct ( non fasting) LDL, a high sensitivity CRP as well as toxicity monitoring labs including a complete blood count and a comprehensive panel. During the baseline visit DNA is collected upon consent - to allow future genetic and pharmacogenetic studies- and also serology markers and immunoglobulin levels. During the first three visits RNA serum and plasma for storage and future experiments are collected.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients who present at enrolling sites across the US are invited to enroll if eligible.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625650
|United States, New York|
|The Center For Rheumatoligy|
|Albany, New York, United States, 12159|
|Study Chair:||Dimitrios Pappas, MD, MPH||CORRONA INC.|