UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019440 |
|---|---|
| Receipt number | R000022489 |
| Scientific Title | Okayama university prospective cohort study for outcomes of patients with rheumatoid arthritis in common practice |
| Date of disclosure of the study information | 2015/10/27 |
| Last modified on | 2015/11/04 16:09:10 |
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Basic information
Public title
Okayama university prospective cohort study for outcomes of patients with rheumatoid arthritis in common practice
Acronym
Okayama university prospective cohort study for outcomes of patients with rheumatoid arthritis in common practice (OKRA2)
Scientific Title
Okayama university prospective cohort study for outcomes of patients with rheumatoid arthritis in common practice
Scientific Title:Acronym
Okayama university prospective cohort study for outcomes of patients with rheumatoid arthritis in common practice (OKRA2)
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate factors for safety, efficacy, and adverse event in common practice for rheumatoid arthritis
Basic objectives2
Others
Basic objectives -Others
DAS28 (disease activity score 28)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
DAS28 (disease activity score 28)
Key secondary outcomes
Steinbrocker Stage(Joint X-Ray),CDAI,SDAI,HAQ,serum CRTN,eGFR,urine protein g/gCr, adverse event(Allergic symptoms, Digestive symptom, Interstitial pneumonia, Renal dysfunction, Liver dysfunction, Serious infections)
Fever)
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis in Okayama University Hospital
Patients meet the 2010 ACR/EULAR classification criteria for the rheumatoid arthritis
Key exclusion criteria
1: Patients under 20 years or over 85 years of age at the onset
2: Patients who are judged inappropriate by attending physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ei Sada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL
086-235-7235
sadakenn@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Morishita |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, 700-8558
TEL
0862357235
Homepage URL
miticokomatsu@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山大学大学院医歯薬学総合研究科（Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences）、岡山市立市民病院（Okayama City Hospital）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Subject)Patients with rheumatoid arthritis in Okayama University Hospital
Patients meet the 2010 ACR/EULAR classification criteria for the rheumatoid arthritis (Patients 20-84 years of age at the onset)
Evaluation item)
1) To elucidate the association between primary outcome and patients characteristics and treatment by multivariate analysis.
2) To elucidate the association between secondary outcome and patients characteristics and treatment by multivariate analysis.
3) To elucidate the risk factor of renal impairment by multivariate analysis.
4) Adverse effect
Management information
Registered date
| 2015 | Year | 10 | Month | 21 | Day |
Last modified on
| 2015 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022489
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
