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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625650
First Posted: June 21, 2012
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Corrona, LLC.
  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

Resource links provided by NLM:


Further study details as provided by Corrona, LLC.:

Biospecimen Retention:   Samples With DNA
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.

Enrollment: 2795
Study Start Date: October 2010
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01625650


Locations
United States, New York
The Center For Rheumatoligy
Albany, New York, United States, 12159
Sponsors and Collaborators
Corrona, LLC.
University of Alabama at Birmingham
Investigators
Study Chair: Dimitrios Pappas, MD, MPH CORRONA INC.
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corrona, LLC.
ClinicalTrials.gov Identifier: NCT01625650     History of Changes
Other Study ID Numbers: New England IRB 02-021
NEIRB 02-021 ( Registry Identifier: Corrona, LLC )
First Submitted: June 19, 2012
First Posted: June 21, 2012
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Corrona, LLC.:
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