Consortium of Rheumatology Researchers of North America, Inc.: The CORRONA CERTAIN Sub-study
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Purpose
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).
| Condition |
|---|
|
Rheumatoid Arthritis |
| 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.
| Estimated Enrollment: | 3000 |
| Study Start Date: | October 2010 |
| Groups/Cohorts |
|---|
|
Rheumatology
Patients who present at enrolling sites across the US are invited to enroll if eligible.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Ppproximately 3,000 subjects from 100 sites will participate in this Sub-study and that approximately 30, and up to 200, subjects from this site will be enrolled.
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
Contacts and Locations| United States, New York | |
| The Center For Rheumatoligy | |
| Albany, New York, United States, 12159 | |
| Study Chair: | Dimitrios Pappas, MD, MPH | CORRONA INC. |
More Information
Additional Information:
No publications provided
| Responsible Party: | The Consortium of Rheumatology Researchers of North America, Inc. |
| ClinicalTrials.gov Identifier: | NCT01625650 History of Changes |
| Other Study ID Numbers: | New England IRB 02-021, NEIRB 02-021 |
| Study First Received: | June 19, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by The Consortium of Rheumatology Researchers of North America, Inc.:
|
Rheumatoid Arthritis Registry RA |
Biologic Medications Rheumatology |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013