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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007432
Receipt No. 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

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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
Email 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
Email info@npo-acro.jp

Sponsor
Institute Keio University
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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