Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corrona Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

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.
 
ClinicalTrials.gov Identifier: NCT01402661
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2011
Last Update Posted : February 12, 2020
Sponsor:
Collaborators:
University of Massachusetts, Worcester
University of Alabama at Birmingham
Brigham and Women's Hospital
Information provided by (Responsible Party):
Corrona, LLC.

Brief Summary:
This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA in a cohort of patients cared for by rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Condition or disease
Rheumatoid Arthritis

Detailed Description:

The primary objective for this registry is to systematically collect and document use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs), biologic agents, and any other treatments currently used in the management of RA.

The design is a prospective, non-interventional registry for patients with RA under the care of a rheumatologist. Longitudinal data are collected from both patients and their treating rheumatology providers during routine clinical encounters using a structured and standardized data collection method. The scope of data collection includes but is not limited to patient demographics, disease duration, medical history (including all prior and current treatments for RA), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes. After the enrollment visit, RA patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals. Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all Corrona related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Layout table for study information
Study Type : Observational
Actual Enrollment : 33312 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Corrona Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry
Study Start Date : February 2002
Estimated Primary Completion Date : December 2100

Resource links provided by the National Library of Medicine


Group/Cohort
Rheumatoid Arthritis
Pts presenting to enrolling sites across the US are invited to enroll if eligible.



Primary Outcome Measures :
  1. Patterns, effectiveness, and safety of DMARDs, biologic agents and any other treatments currently used in the management of RA [ Time Frame: Data are collected on subjects for as long as they consent to remain in the study ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are enrolled in the CORRONA Data Collection Program during regularly-scheduled office visits. Selected rheumatologists are invited to participate as investigators in the CORRONA Data Collection Program. Physicians are selected carefully in an effort to ensure enrollment of subjects that represent a reasonable representation of a cross-section of the population throughout the country with rheumatic diseases. All potential sites are screened for clinical research experience and adherence to GCP (Good Clinical Practice) guidelines
Criteria

Inclusion Criteria:

  1. Be at least 18 years of age or older.
  2. Be able and willing to provide written consent for participation in the registry as well as Personally Identifiable Information (PII) that includes Full Name and Date of Birth at a minimum.
  3. Have been diagnosed with rheumatoid arthritis by a rheumatologist.
  4. Meet at least one of the following criteria:

(A) Currently receiving an Eligible Medication** that was started within 365 days of the Enrollment Visit.

i. A temporary interruption of an Eligible Medication is allowed if the interruption in treatment lasted <180 days.

(B) Prescribed or receiving the first dose of an Eligible Medication** on the day of the Enrollment Visit.

(C) Diagnosed with RA within 365 days of the Enrollment Visit regardless of treatment regimen ("Early RA").

Exclusion Criteria:

The patient must not:

  1. Have a diagnosis of Juvenile idiopathic arthritis (JIA), Psoriatic arthritis (PsA), Spondyloarthritis (SpA), Ankylosing spondylitis (AS), Systemic lupus erythematosus (SLE), or any other form of autoimmune inflammatory arthritis.
  2. Be starting only a non-eligible medication, unless the patient was diagnosed with RA within 365 days of the Enrollment Visit. Non-eligible medications include conventional DMARDs - for example methotrexate, sulfasalazine, leflunomide, etc. - and including prednisone.
  3. Be participating in or planning to participate in a double-blind randomized clinical trial of an RA drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.

    Early Follow-Up Visit Criteria

    To be eligible for an early Corrona Follow-Up Visit that is conducted <150 days since the last registry visit, the following conditions must be met:

  4. A follow-up set of questionnaires should always be completed whenever a registry subject is being prescribed or receiving the first dose of a new (different) Eligible Medication** at a routine office visit. If this occurs less than 150 days from the previous visit at which Corrona questionnaires had been completed, it is considered an "Early Follow-Up Visit." The next anticipated visit that follow-up questionnaires would be completed would be calculated off the Early Follow-up Visit date (=>150 days). Prior use of an Eligible Medication** does not exclude a patient from an Early Follow-Up visit.

    • Eligible Medications are biologics, biosimilars, and JAK-inhibitors FDA-approved for the treatment of RA. Prior use of an Eligible Medication does not exclude a patient from enrollment

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): NCT01402661


Locations
Layout table for location information
United States, New York
Center for Rheumatology
Albany, New York, United States, 12206
Sponsors and Collaborators
Corrona, LLC.
University of Massachusetts, Worcester
University of Alabama at Birmingham
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Study Director: Joel Kremer, MD Center for Rheumatology
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Corrona, LLC.
ClinicalTrials.gov Identifier: NCT01402661    
Other Study ID Numbers: Corrona-RA-100
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: January 2020
Keywords provided by Corrona, LLC.:
rheumatoid arthritis
psoriatic arthritis
disease registry
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases