UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007432 |
|---|---|
| Receipt number | R000008476 |
| Scientific Title | Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody. |
| Date of disclosure of the study information | 2012/03/02 |
| Last modified on | 2014/03/05 10:55:31 |
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Basic information
Public title
Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.
Acronym
PRISM Study
Scientific Title
Prospective research of infliximab treatment in active RA patients refractry to anti-interleukin six receptor monoclonal antibody.
Scientific Title:Acronym
PRISM Study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The Remission ratio by treatment with IFX is assessed to effect insufficient rheumatoid arthritis patient by TCZ.
The cytokine concentrations before and after treatment are compared and the control meaning of the cytokine is assessed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The remission rate by SDAI score at 54 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Infliximab and Methotrexate.
Patient is treated with IFX 3mg/kg for 0, 2, or 6 weeks, and henceforth every 8 weeks till 46weeks. Disease activity is assessed every 4weeks (suitable) or every 8 weeks (indispensable), and if SDAI Score 3.3 or more, it will change into of 3mg/kg 4week or 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks. If not remission(SDAI Score 3.3 or more), after change into of 3mg/kg 4week interval medication, it will change into of 6mg/kg 4week interval medication, and will administer a drug to patient till 50 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with rheumatoid arthritis diagnosed according to the criteria of the American College of Rheumatology (ACR).
Patient treated of TCZ for more than 12 weeks.
SDAI Score more than 3.3 of TCZ treatment the last.
SDAI score 3.3 or more at start of the examination (exceeds 3 weeks from TCZ treatment the last.)
Having received and thoroughly understood an adequate explanation about participation in the study, patients who have personally and voluntarily provided written informed consent.
Key exclusion criteria
Patient has received IFX in the past.
During a TCZ washout period, Patient treated of biologics and immunosuppressant which does not have adaptation of preparation or rheumatoid arthritis.
Patient is contraindication of IFX and MTX.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takeuchi |
Organization
Keio University School of Medicine
Division name
Division of Rheumatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo JAPAN
TEL
03-3353-1211
info@npo-acro.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ACRO |
Organization
NPO Advanced Clinical Research Organization
Division name
Advanced Clinical Research Organization
Zip code
Address
4F Hoei Fuchu Building, 2-10-3 Kotobukicyo, Fucyu-shi, Toyo, Japan
TEL
042-352-7676
Homepage URL
info@npo-acro.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
NPO
Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 03 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
Management information
Registered date
| 2012 | Year | 03 | Month | 02 | Day |
Last modified on
| 2014 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
