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

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 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


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

Value
https://center6.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