UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005773 |
|---|---|
| Receipt number | R000006726 |
| Scientific Title | Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis |
| Date of disclosure of the study information | 2011/06/14 |
| Last modified on | 2018/12/19 09:36:20 |
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Basic information
Public title
Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis
Acronym
Quantification of knee cartilage in rheumatoid arthritis by MRI analysis
Scientific Title
Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis
Scientific Title:Acronym
Quantification of knee cartilage in rheumatoid arthritis by MRI analysis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have established a software for quantification of knee articular cartilage on MRI, validated the reproducibility and reliability, and investigate the effect of ETN+MTX treatment on cartilage deterioration on MRI as compared with MTX alone treatment and correlation between cartilage deterioration on MRI and endpoints such as mTSS, SDAI and DAS28
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI will be analysed with semi-automated software for quantification of knee articular cartilage[Time Frame:0, 3, 6, 12 months]
Key secondary outcomes
1) Radiographic evaluation: Modified total Sharp score (mTSS) [Time Frame:0, 3, 6, 12 months ]
2) SDAI remission rate [Time Frame:0, 3, 6, 12 months ]
3) Boolean-based definition remission rate [Time Frame:0, 3, 6, 12 months ]
4) CDAI remission rate [Time Frame:0, 3, 6, 12 months ]
5) Disease Activity Score (DAS28) remission rate [Time Frame:0, 3, 6, 12 months ]
6) EULAR response rate [Time Frame:0, 3, 6, 12 months ]
7) ACR20, 50 and 70 response rates [Time Frame:0, 3, 6, 12 months ]
8) Health Assessment Questionnaire (HAQ) improvement rate [Time Frame:0, 3, 6, 12 months ]
9) EQ-5D [Time Frame:0,12 months ]
10) C-reactive protein(CRP) in serum [Time Frame:0, 3, 6, 12 months ]
11) IgM RF in serum [Time Frame:0, 3, 6, 12 months ]
12) MMP-3 in serum [Time Frame:0, 3, 6, 12 months ]
13) Anti-CCP antibody in serum [Time Frame:0months ]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ETN+MTX
Interventions/Control_2
MTX
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
1. Patient has had a diagnosis of RA for less than two years as defined according to the American College of Rheumatology (ACR) Criteria for RA.
2. RA patient has moderate or severe disease activity, as defined by DAS28 (3.2 <= DAS28), despite the treatment with DMARDs (including 8mg >=; MTX weekly) for not less than three months.
3. Patient is an inpatient or outpatient.
Key exclusion criteria
1. Patient does not meet the guideline of anti-TNF therapy in RA patients.
2. Patient is septicemic or at risk of sepsis.
3. Patient has serious infection.
4. Patient has active tuberculosis.
5. Patient has a history of hypersensitivity to ingredients of the study drugs (ETN and MTX).
6. Patient has any current or previous demyelinating diseases.
7. Patient has congestive heart failure.
8. Patient cannot be treated with MTX ( 6 mg/week) in RA patients.
9. Patient has bone marrow suppression.
10. Patient has chronic hepatic disease.
11. Patient has renal dysfunction.
12. Patient is a nursing woman.
13. Patient is pregnant or possibly pregnant.
14. Patient has pleural effusion or ascites
15. Patient has contraindications for MRI
16. Patient is otherwise ineligible to participate in this study in the investigator's opinion.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Oka |
Organization
22nd Century Medical & Research Center, the University of Tokyo
Division name
Departments of Joint Disease Research
Zip code
Address
Hongo 7-3-1, Bunkyo, Tokyo 113-8655, Japan.
TEL
03-5800-9178
okah-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Oka |
Organization
22nd Century Medical & Research Center, the University of Tokyo
Division name
Departments of Joint Disease Research
Zip code
Address
7-3-1 Bunkyo-ku, Hongo, Tokyo
TEL
03-5800-9178
Homepage URL
okah-tky@umin.ac.jp
Sponsor or person
Institute
22nd Century Medical & Research Center, the University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Pfizer Inc.
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 06 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | 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
Management information
Registered date
| 2011 | Year | 06 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006726
