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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030109
Receipt No. R000034378
Scientific Title Efficacy of infliximab as a switched biologic in rheumatoid arthritis patients in daily clinical practice
Date of disclosure of the study information 2017/12/01
Last modified on 2018/11/27

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Basic information
Public title Efficacy of infliximab as a switched biologic in
rheumatoid arthritis patients in daily clinical practice
Acronym Efficacy of infliximab as a switched biologic in
rheumatoid arthritis patients in daily clinical practice
Scientific Title Efficacy of infliximab as a switched biologic in
rheumatoid arthritis patients in daily clinical practice
Scientific Title:Acronym Efficacy of infliximab as a switched biologic in
rheumatoid arthritis patients in daily clinical practice
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy and safety of switching to infliximab (IFX) from other biological disease-modifying anti-rheumatic drugs (bDMARDs) among Japanese patients with rheumatoid arthritis (RA) in daily practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endpoint in this study was the rate of achievement of LDA or remission at week 22after the introduction of infliximab. The adverse events during the observation period.
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 Patients receive IFX (3 mg/kg) at 0, 2, 6, 14 and 22 weeks. The dose escalation of IFX to 6 mg/kg was allowed after 14 weeks if DAS28-ESR remission had not been achieved according to medicinal application of the national insurance program in Japan.
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

Not applicable
Gender Male and Female
Key inclusion criteria RA patients who had not achieved low disease activity (LDA) status on the DAS28-ESR LDA despite undergoing bDMARD therapy.
Key exclusion criteria non
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kawakami
Organization Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name Department of Rheumatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan.
TEL 095-819-7262
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masataka Umeda
Organization Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Scie
Division name Department of Rheumatology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan.
TEL 095-819-7262
Homepage URL
Email umeda@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Immunological Medicine
Efficacy of infliximab as a switched biologic in rheumatoid arthritis patients in daily clinical practice
Masataka Umeda, Tomohiro Koga et al.
From other patients to infliximab (IFX) from other biological disease-modifying anti-rheumatic drugs (bDMARDs) among Japanese patients with rheumatoid arthritis (RA) in daily practice.
Methods: We examined 24 consecutive RA patient who had not achieved low disease activity (LDA) as the Disease Activity Score-28 for Rheumatoid Arthritis with Erythrocyte Sedimentation Rate (DAS 28 - ESR) despite previous bDMARD therapy in this cohort study. DAS 28 - ESR LDA at 22 weeks post - IFX introduction, by performing univariate analysis.
Results: The median DAS 28 - ESR at baseline was 5.41. Sixteen patients (66.7%) had been treated with a tumor necrosis factor inhibitor (TNF - i), and the other eight patients (33.3%) received a non - TNF - i abatacept or tocilizumab) achieved LDA or remission at 22 weeks. Univariate analyses showed that the variable to predict LDA achievement at 22 weeks was tender joints (> 8 counts) at baseline (adjusted odds ratio, 0.10; 95 % confidence interval, 0.01 - 0.63; P = 0.02), whereas the other baseline clinical variables including MTX dosage, disease duration and the previous usage of TNF-i not not associated with LDA achievement. and infection requiring hospitalization was observed in one patient.
Conclusion: Switching to IFX is effective to achieve LDA or remission for RA patients refractory to bDMARDs.
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 Completed
Date of protocol fixation
2014 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 09 Day
Last follow-up date
2018 Year 10 Month 12 Day
Date of closure to data entry
2018 Year 10 Month 12 Day
Date trial data considered complete
2018 Year 10 Month 12 Day
Date analysis concluded
2018 Year 10 Month 12 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 24 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034378

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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