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

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 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


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

Value
https://center6.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