Rheumatoid ArthritisNCT02737449
CorEvitas Japan Rheumatoid Arthritis (RA) Registry
An observational study of Rheumatoid Arthritis, run by CorEvitas.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2100
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The CorEvitas Japan RA Registry has a target enrollment of approximately 2,600 subjects with no defined upper limit on enrollment.This study will recruit patients from approximately 60 clinical sites from a broad geographic distribution in Japan; however, there is no defined upper or lower limit on the number of sites expected to participate.
Who may be able to join
- 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.
Who cannot join
- The subject is unable or unwilling to provide informed consent to participate in the registry.
About this study
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. This includes assessing the incidence of adverse events of special interest, in a real-world population of rheumatoid arthritis patients. Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, and current treatment practices.
Read the detailed description
The design is a prospective, multicenter, non-interventional, observational study for patients with RA who are newly prescribed eligible medications 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 CorEvitas 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 CorEvitas 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse events (AEs) will be measured.
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.
Measured: 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.
Secondary outcomes (13)
The number of tender and swollen joints, 28 joint counts, will be recorded as a measure of disease activity.
Measured: 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.
Patient pain assessment will be collected using visual analogue scale measurements (VAS)
Measured: 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.
Physician global disease severity assessment will be collected using VAS
Measured: 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.
Patient global disease severity assessment will be collected using VAS.
Measured: 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.
The duration of morning stiffness will be recorded in minutes or hours. enrollment and subsequent visits
Measured: 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.
The severity of morning stiffness, stiffness and associated pain, will be recorded using VAS.
Measured: 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.
DAS-28 ESR rates will be calculated. .
Measured: 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.
Composite indices of disease activity: CDAI score, will be calculated from the elements in the CorEvitas Questionnaires.
Measured: 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.
Composite indices of disease activity, ACR score, will be calculated from the elements in the CorEvitas Questionnaires.
Measured: 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.
Composite indices of disease activity, DAS score, will be calculated from the elements in the CorEvitas Questionnaires.
Measured: 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.
PROs will be collected via instruments including the EQ-5D questionnaire.
Measured: 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.
PROs will be collected via instruments including the HAQ-DI questionnaire.
Measured: 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.
PROs will be collected via instruments including the WPAI questionnaire.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2100 (estimated)
- Study completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737449
- Sponsor's protocol ID
- CorEvitas-RA-102
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2016
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Japan Rheumatoid Arthritis (RA) Registry
- ClinicalTrials.gov ID
- NCT02737449
- Acronym / sponsor ID
- CorEvitas-RA-102
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- Jul 2016
- Primary completion
- Dec 2100 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This includes assessing the incidence of adverse events of special interest, in a real-world population of rheumatoid arthritis patients. Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, and current treatment practices.
Detailed description
The design is a prospective, multicenter, non-interventional, observational study for patients with RA who are newly prescribed eligible medications 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 CorEvitas 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 CorEvitas 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The CorEvitas Japan RA Registry has a target enrollment of approximately 2,600 subjects with no defined upper limit on enrollment.This study will recruit patients from approximately 60 clinical sites from a broad geographic distribution in Japan; however, there is no defined upper or lower limit on the number of sites expected to participate.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- The subject is unable or unwilling to provide informed consent to participate in the registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
13 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
Composite indices of disease activity: CDAI score, will be calculated from the elements in the CorEvitas 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.
Composite indices of disease activity, ACR score, will be calculated from the elements in the CorEvitas 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.
Composite indices of disease activity, DAS score, will be calculated from the elements in the CorEvitas 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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by CorEvitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.