UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030109 |
|---|---|
| Receipt number | 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 13:54:20 |
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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
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
umeda@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034378
