Consortium of Rheumatology Researchers of North America, Inc.: The CORRONA CERTAIN Sub-study

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
The Consortium of Rheumatology Researchers of North America, Inc.
ClinicalTrials.gov Identifier:
NCT01625650
First received: June 19, 2012
Last updated: January 16, 2013
Last verified: June 2012
  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 The Consortium of Rheumatology Researchers of North America, Inc.:

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.


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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625650

Locations
United States, New York
The Center For Rheumatoligy
Albany, New York, United States, 12159
Sponsors and Collaborators
The Consortium of Rheumatology Researchers of North America, Inc.
University of Alabama at Birmingham
Investigators
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 September 18, 2014