UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005773
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email okah-tky@umin.ac.jp

Sponsor
Institute 22nd Century Medical & Research Center, the University of Tokyo
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.