UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001798 |
|---|---|
| Receipt number | R000001448 |
| Scientific Title | Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study) |
| Date of disclosure of the study information | 2009/03/25 |
| Last modified on | 2011/10/25 18:07:44 |
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Basic information
Public title
Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study)
Acronym
PRECEPT study
Scientific Title
Prevention of cartilage destruction in rheumatoid arthritis by etanercept (PRECEPT study)
Scientific Title:Acronym
PRECEPT study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
When using biologics in rheumatoid arthritis, we make it clear whether a gap occurs to joint destruction inhibiting effect by its dosage.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total Sharp score (erosion and joint space narrowing)
Key secondary outcomes
DAS28
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of etanercept by 50 mg/week for one year
Interventions/Control_2
Injection of etanercept by 25 mg/week for one year
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients must have active rheumatoid arthritis at enrollment with requirements that they have more than 4 swollen joints or more than 4 tender joints (using a 68-joint count). The elevations in the level of C reactive protein or erthrocyte sedimentation rate are not required. DAS(disease activity score)28 must be over 3.2 or patients must desire the use of biologics when DAS28<3.2.
Key exclusion criteria
Cases who have Joint destruction on hand and foot, in whom we can't measure modified Sharp score. Except Eetanercept dose, there is no restriction for other medicine use.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Koike |
Organization
Osaka City University Medical School
Division name
Rheumatosurgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Koike |
Organization
Osaka City University Medical School
Division name
Rheumatosurgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
Homepage URL
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Team RA, Rheumatosurgery, Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Rheumatosurgery, Osaka City University Medical School
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 03 | Month | 25 | 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
Completed
Date of protocol fixation
| 2008 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 25 | Day |
Last modified on
| 2011 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001448
