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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023006
Receipt No. R000026517
Scientific Title Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Date of disclosure of the study information 2016/07/15
Last modified on 2019/07/07

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Basic information
Public title Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Acronym IFX-2nd
Scientific Title Usefullness of infliximab as a second tumor necrosis factor inhibitor in patients with rheumatoid arthritis with inadequate response to tumor necrosis factor inhibitor
Scientific Title:Acronym IFX-2nd
Region
Japan

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

Objectives
Narrative objectives1 Serum tumor necrosis factor (TNF) level was reported to be relatively higher in the patients with rheumatoid arthritis (RA) especially with inadequate response to first TNF inhibitor (TNFi). For those RA patients with inadequate response to TNFi it was reported that increasing dose of TNFi was required in order to reduce disease activity of RA. Because increasing dose or shorter interval of administration was approved for the use of infliximab (IFX), IFX seems ideal for the purpose of use in such cases. In this study we investigate the better efficacy of increasing dose of IFX than ordinary dose from the start in patients with RA with inadequate response to TNFi except IFX.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Evaluation of disease activity score 28-CRP (DAS28-CRP) at 30 weeks
Key secondary outcomes 1) Evaluation of structural damage by modified total Sharp score at 54 weeks
2) Evaluation of synovitis by ultrasound at 54 weeks
3) Evaluation of blood test at 54 weeks
4) Evaluation of modified Health Assessment Questionnaire at 54 weeks
5) Adverse reaction at 54 weeks
6) Evaluation of DAS28-CRP at 30 weeks

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Dose comparison
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administrated with 3mg/kg of IFX
Interventions/Control_2 administrated with 10mg/kg of IFX
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1) Out-patients who is planned to receive IFX with active moderate-to-severe RA with inadequate response to adalimumab, etanercept, golimumab or certolizumab pegol
2) The patients who administrated with methotrexate
3) Patients must have taken stable dose of NSAID, glucocorticoid, or conventional synthetic disease modifying anti rheumatic drugs
4) Aged 20 years or older and less than 85 years old
5) The patients who provided their informed consent to participate in the study
Key exclusion criteria 1) The patients with inadequate response to IFX after 6-weekloading administration
2) The patients with arthritic condition other than Ra
3) The patients who is planned to undergo surgery
4) Patients with allergy to IFX
5) Patients who is pregnant or lactate
6)patients who have received IFX administration
7) Those who are not approved to be eligible to this study by corresponding researcher or co-researchers
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kentaro
Middle name
Last name Inui
Organization Osaka City University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 545-8585
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL 06-6645-3851
Email inuken@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Inui
Organization Osaka City University Graduate School of Medicine
Division name Orthopaedic Surgery
Zip code 545-8585
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka545-8585, Japan
TEL 06-6645-3851
Homepage URL
Email inuken@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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 Osaka City University Hospital Certified Review Board
Address 1-2-7-601 Asahi-machi, Abeno-ku, Osaka
Tel 06-6645-3456
Email ethics@med.osaka-cu.ac.jp

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
2016 Year 07 Month 15 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 1
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 Terminated
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
2016 Year 07 Month 01 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026517

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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