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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN C000000452
Receipt No. R000000550
Scientific Title Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept
Date of disclosure of the study information 2006/08/01
Last modified on 2006/07/24

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Basic information
Public title Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept
Acronym RIVERAME
Scientific Title Remission Induction of Very Early Rheumatoid Arthritis with Methotrexate and Etanercept
Scientific Title:Acronym RIVERAME
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is designed to explore the efficacy of treatment with combined methotrexate and etanercept in early rheumatoid arthritis by comparing the outcome obtained with conventional treatmentment with anti-rheumatic drugs
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Inhibitiion of joint destruction as shown by Sharp score, Knee joint X-ray, and serum MMP3 levels, and remission rates evaluated by DAS28
Key secondary outcomes

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 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 methotrexate 8mg/week
Interventions/Control_2 methotrexate 8mg/week and
etanercept(25mg x1-2/week) for 3 months
Interventions/Control_3 methotrexate 8mg/week and
etanercept(25mgx1-2/week) for 6 months
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with reheumatoid arthritis who satisfiy the 1987 ACR criteria(within one year from the onset),show DAS28 more than 3.2 and give inforted consent in a witten form
Key exclusion criteria patients who are contra indicated for methotrexate or etanercept
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsei Hirohata
Organization Teikyo University School of Medicine
Division name Department of Internal Medicine
Zip code
Address 2-11-1 Kaga, Itabashiku, Tokyo
TEL 03-3964-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shunsei Hirohata
Organization Teikyo University School of Medicine
Division name Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email shun-tei@umin.ac.jp

Sponsor
Institute Johoku Biological Summit
Institute
Department

Funding Source
Organization Takeda Pharmaceutical Co.
Organization
Division
Category of Funding Organization Profit organization
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
2006 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2006 Year 06 Month 14 Day
Date of IRB
Anticipated trial start date
2006 Year 08 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 07 Month 24 Day
Last modified on
2006 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000550

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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