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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001798
Receipt No. 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

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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
Email

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
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Team RA, Rheumatosurgery, Osaka City University Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001448

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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