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Corrona Japan Rheumatoid Arthritis (RA) Registry

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ClinicalTrials.gov Identifier: NCT02737449
Recruitment Status : Enrolling by invitation
First Posted : April 14, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Corrona, LLC.

Brief Summary:
The primary objective is to prospectively study the comparative effectiveness and comparative safety of approved therapies for RA in a Japanese cohort of patients treated by rheumatologists. Specifically the effectiveness and safety of newer classes and dosages of disease modifying anti-rheumatic drugs (DMARDs); e.g. higher dose methotrexate (MTX), non-tumor necrosis factor (TNF) biologics, and Janus Kinase (JAK) inhibitors) will be compared with anti-TNF biologics.

Condition or disease
Rheumatoid Arthritis

Detailed Description:

The design is a prospective, multicenter, non-interventional, observational study for patients with RA who are newly prescribed MTX, a biologic DMARD, or a JAK inhibitor at the time of enrollment into the registry. The drug is prescribed per the physician's decision which precedes the decision to enroll the patient into the registry. Longitudinal follow-up data is obtained via Corrona Questionnaires completed by both patients and their treating rheumatologists during routine clinical practice. The Enrollment and Follow-Up Questionnaires capture data on patient demographics, targeted medical history including a history of all prior treatments for RA, smoking history, disease duration, disease severity, disease activity, laboratory results, comorbidities, hospitalizations and other targeted safety events.

The study will also monitor a range of clinical effectiveness, patient reported outcomes (PROs), health economic, and safety outcomes, including infections, malignancies and cardiovascular events, among other safety outcomes. Standard components of the European League Against Rheumatism (EULAR) (Disease Activity Score -28 joint count) and American College of Rheumatology (ACR) response criteria, including tender and swollen 28 joint counts, physician and patient global assessment, morning stiffness and pain will be collected at all study visits to enable comparisons of composite disease activity scores (e.g. remission) and response criteria. disease activity score (DAS)-28 erythrocyte sedimentation rates (ESR) will be calculated where possible, as Japanese physicians routinely collect ESR on a more regular basis than U.S. physicians. Composite indices of disease activity, clinical disease activity index (CDAI), DAS, and ACR scores may be calculated from the elements in the Corrona Questionnaire for publication. In addition, PROs will be collected via instruments including the EuroQol (EQ)-5D, health assessment questionnaire (HAQ)-DI, and work productivity activity impairment instrument (WPAI) questionnaire.

A primary objective of the registry is analysis of comparative safety. The registry may be linked to other registries for the purposes including comparative safety or outcome studies. The program-specific subject identifier number (ID) will be collected for subjects that participate or have participated in a post-market surveillance study. The ID will be used for to ensure the accuracy of safety reporting to regulators by reducing duplicate reports Note that this study has not been submitted to a United States institutional review board. It has been approved by Japanese Authorities.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 8 Years
Official Title: Corrona Japan Rheumatoid Arthritis (RA) Registry
Study Start Date : July 2016
Estimated Primary Completion Date : December 2100
Estimated Study Completion Date : December 2100

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Incidence rate of adverse events (AEs) will be measured. [ Time Frame: e outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
    Number of patients who develop malignancy, cardiovascular disease, serious infection, inflammatory bowel syndrome, hepatic events, neurological events and general serious adverse events (SAEs) in Japanese clinical practice will be assessed in subjects receiving Conventional synthetic DMARDs, JAK inhibitors, Anti-TNF biologic DMARDs, and Non-TNF biologic DMARDs as standard of care.


Secondary Outcome Measures :
  1. The number of tender and swollen joints, 28 joint counts, will be recorded as a measure of disease activity. [ Time Frame: 1. the outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  2. Patient pain assessment will be collected using visual analogue scale measurements (VAS) [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  3. Physician global disease severity assessment will be collected using VAS [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  4. Patient global disease severity assessment will be collected using VAS. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  5. The duration of morning stiffness will be recorded in minutes or hours. enrollment and subsequent visits [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  6. The severity of morning stiffness, stiffness and associated pain, will be recorded using VAS. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  7. DAS-28 ESR rates will be calculated. . [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  8. Composite indices of disease activity: CDAI score, will be calculated from the elements in the Corrona Questionnaires. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  9. Composite indices of disease activity, ACR score, will be calculated from the elements in the Corrona Questionnaires. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  10. Composite indices of disease activity, DAS score, will be calculated from the elements in the Corrona Questionnaires. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  11. PROs will be collected via instruments including the EQ-5D questionnaire. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  12. PROs will be collected via instruments including the HAQ-DI questionnaire. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]
  13. PROs will be collected via instruments including the WPAI questionnaire. [ Time Frame: The outcome measure will be assessed at enrollment and at each subsequent study visit, approximately every 6 months, through study completion, an average of 8 years. ]


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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

The Corrona Japan RA Registry has a target enrollment of approximately 2,000 subjects being prescribed for the first-time, a medication for RA from one of the following drug classes: Conventional DMARDs, JAK inihibitors, Anti-TNF biologic DMARDs, Non-TNF biologic DMARDs.

If during follow-up a subject stops treatment with the eligible medication prescribed at enrollment, that subject should still be followed long-term in the registry.

This study will recruit patients from approximately 40 clinical sites from a broad geographic distribution in Japan. Subject enrollment will be monitored to obtain 4 subgroups of 500 patients each segmented by drug class with enrollment closing when a cap of 500 patients is reached. Investigators may recruit patients into any drug subgroup in any order until the study cap is reached. Additional subgroups may be added as new drugs are approved. Additional patients may be added to maintain subgroup numbers.

Criteria

Inclusion Criteria:

  • The subject must be diagnosed with rheumatoid arthritis according to the 1987 ACR or the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria
  • The subject must be at least 18 years of age or older
  • The subject must be able and willing to provide written consent
  • The subject must be prescribed or switching to an eligible medication for the first time ever at the Enrollment Visit. History of concomitant treatment with other eligible medications does not exclude a subject from enrollment.

Exclusion Criteria:

  • The subject is unable or unwilling to provide informed consent to participate in the registry.

Additional Information:

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Responsible Party: Corrona, LLC.
ClinicalTrials.gov Identifier: NCT02737449     History of Changes
Other Study ID Numbers: Corrona-RA-102
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases