UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021394 |
|---|---|
| Receipt number | R000024117 |
| Scientific Title | Corrona Japan Rheumatoid Arthritis (RA) Registry |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2024/09/13 16:23:47 |
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Basic information
Public title
Corrona Japan Rheumatoid Arthritis (RA) Registry
Acronym
Corrona Japan Rheumatoid Arthritis (RA) Registry
Scientific Title
Corrona Japan Rheumatoid Arthritis (RA) Registry
Scientific Title:Acronym
Corrona Japan Rheumatoid Arthritis (RA) Registry
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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 DMARDs (e.g. higher dose MTX, non-TNF biologics, and JAK inhibitors) will be compared with anti-TNF biologics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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 DMARDs (e.g. higher dose MTX, non-TNF biologics, and JAK inhibitors) will be compared with anti-TNF biologics.
Key secondary outcomes
Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, and current treatment practices.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The subject must be diagnosed with rheumatoid arthritis according to the 1987 ACR or the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria
2) The subject must be at least 18 years of age or older
3) The subject must be able and willing to provide written consent
4) The subject must be prescribed or switching to an eligible medication or the first time ever at the Enrollment Visit. History of or concomitant treatment with other eligible medications does not exclude a subject from enrollment.
Key exclusion criteria
NA
Target sample size
2600
Research contact person
Name of lead principal investigator
| 1st name | Mitsumasa |
| Middle name | |
| Last name | Kishimoto |
Organization
Kyorin University Hospital
Division name
Rheumatology and Collagen Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
kishimotomi@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Nagahata |
Organization
Fortrea Japan K.K.
Division name
Clinical Development Services
Zip code
104-6108
Address
Harumi Triton Square Office Tower Y8F, 1-8-11, Harumi, Chuo-ku, Tokyo
TEL
03-6837-9500
Homepage URL
Kazuyoshi.Nagahata@fortrea.com
Sponsor or person
Institute
CorEvitas, LLC
Institute
Department
Personal name
Funding Source
Organization
CorEvitas, LLC
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
United States of America
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02737449
Org. issuing International ID_1
Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design:Prospective, multicenter, non-interventional, observational study for patients with rheumatoid arthritis who are newly prescribed methotrexate, 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.
Registry duration:The Corrona Japan RA Registry is a longitudinal, observational study; therefore, the duration of follow-up is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately two (2) years.
Subject recruitment:Participating investigators recruit subjects with RA from their own patient populations as defined by the Subject Eligibility criteria .
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024117
