UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003344 |
|---|---|
| Receipt number | 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 22:14:09 |
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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
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
mk0920@mac.com
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004059
