UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Magnetic resonance image analysis for quantification of knee articular cartilage verified response to etanercept(ETN) in subjects with active rheumatoid arthritis
Title of the study (Brief title)	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	Hiroyuki Oka
Organization	22nd Century Medical & Research Center, the University of Tokyo
Division name	Departments of Joint Disease Research
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	Hiroyuki Oka
Organization	22nd Century Medical & Research Center, the University of Tokyo
Division name	Departments of Joint Disease Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000006726