UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000452 |
|---|---|
| Receipt number | 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 20:21:11 |
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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
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
shun-tei@umin.ac.jp
Sponsor or person
Institute
Johoku Biological Summit
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000550
