UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of infliximab as a switched biologic in rheumatoid arthritis patients in daily clinical practice
Title of the study (Brief title)	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	Atsushi Kawakami
Organization	Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan
Division name	Department of Rheumatology
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	Masataka Umeda
Organization	Unit of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Scie
Division name	Department of Rheumatology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000034378