UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011019 |
|---|---|
| Receipt number | R000012901 |
| Scientific Title | Orencia Clinical study in Early rheumatoid Arthritis using New criteria(Efficacy and safety of MTX therapy and Abatacept/MTX combination therapy in early RA patients in daily clinical practice retrospective observation study.) |
| Date of disclosure of the study information | 2013/06/23 |
| Last modified on | 2013/06/22 15:48:57 |
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Basic information
Public title
Orencia Clinical study in Early rheumatoid Arthritis using New criteria(Efficacy and safety of MTX therapy and Abatacept/MTX combination therapy in early RA patients in daily clinical practice retrospective observation study.)
Acronym
OCEAN study
Scientific Title
Orencia Clinical study in Early rheumatoid Arthritis using New criteria(Efficacy and safety of MTX therapy and Abatacept/MTX combination therapy in early RA patients in daily clinical practice retrospective observation study.)
Scientific Title:Acronym
OCEAN study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical, functional, and radiographic response to MTX therapy versus Abatacept/MTX combination therapy in Japanese Early RA patients encountered in routine clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with SDAI remission (SDAI<=3.3) at week 52
Key secondary outcomes
Proportion of patients with Modified Total Sharp Score: mTSS
, Health Assessment Questionnaire: HAQ,
Disease Activity Score:DAS28 ESR and CRP, Safety at week 52
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who give a full consent to this study
2. Rheumatoid Arthritis patients according to criteria of ACR/EULAR2010
3. Patients with RA for one year or less
4. Patients were MTX naive and biologics naive.
Key exclusion criteria
Patients who are inadequate by investigator's decision.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
School of Medicine, Keio University
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3147
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
School of Medicine, Keio University
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Institute of Rheumatology Tokyo Women's Medical University
University of Occupational and Environmental Health, Japan
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective
Management information
Registered date
| 2013 | Year | 06 | Month | 22 | Day |
Last modified on
| 2013 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012901
