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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003344
Receipt No. R000004059
Scientific Title Induction of the remission by use of infliximab in RA
Date of disclosure of the study information 2010/03/23
Last modified on 2010/03/16

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Basic information
Public title Induction of the remission by use of infliximab in RA
Acronym Induction of the remission by use of infliximab in RA
Scientific Title Induction of the remission by use of infliximab in RA
Scientific Title:Acronym Induction of the remission by use of infliximab in RA
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this clinical trial is to investigate the maintenance of remission after discontinuance of infliximab in rheumatoid arthritis patients who went into remission by the treatment of infliximab in their early stages and maintained remission for more than six months.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of patients who maintain their DAS28-ESR score less than 3.2 one year after discontinuance of infliximb
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients at least 20 years old at enrollment
2) Patients diagnosed with RA based on the 1987 classification criteria of ACR or the 2009 classification criteria of ACR/EULAR
3) Patients who are seropositive for anti-CCP antibody
4) Patients who were treated with MTX for more than twelve weeks before enrollment
5) Patients whose DAS28-ESR score is more than 3.2
6) Patients who have expressed their informed consent in writing
Key exclusion criteria 1) Patients who correspond to the contraindication for use of infliximab and MTX
2) Patients who are more than 70 years old at enrollment
3) Patients who have contracted RA for more than 10 years
4) Patients who are treated with more than 10mg of predonisolone
5) Other patients whom the investigator considers to be unsuitable for the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kawano
Organization Kanazawa University Hospital
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kanazawa University Hospital
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address
TEL 076-265-2253
Homepage URL
Email mk0920@mac.com

Sponsor
Institute Division of Rheumatology, Department of Internal Medicine, Kanazawa University Hospital
Institute
Department

Funding Source
Organization Tanabe-Mitsubishi pharmaceutical co. ltd.
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
2010 Year 03 Month 23 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
2010 Year 03 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 05 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 Nothing

Management information
Registered date
2010 Year 03 Month 16 Day
Last modified on
2010 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004059

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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