UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000017230
Receipt number	R000019886
Scientific Title	Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)
Date of disclosure of the study information	2015/04/22
Last modified on	2015/04/22 02:01:59

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Basic information

Public title

Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To determine the correlation between efficacy of tocilizumab and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Levels of change in oxidative stress markers at 0, 6, and 12 months

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

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Biologic treatment (tocilizumab)

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

1)Patient diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis.
2)Patients who received a full explanation upon participation in this study.
3)Based on the Japan College of Rheumatology "tocilizumab use guidelines for rheumatoid arthritis (RA) (2012 Revised Edition)", patients who meet the following criteria
1:Rheumatoid arthritis patients uncontrolled the use of existing anti-rheumatic drugs to continue the normal dose treatment for 3 months or more.

Key exclusion criteria

1)The patients have an obvious infection in by just before treatment administration, and research investigator or research sharing doctor has determined that they are inappropriate for this study.
2)Based on the Japan College of Rheumatology "tocilizumab use guidelines for rheumatoid arthritis (2012 Revised Edition)", the patients correspond to the administration contraindication
3)The Patients who were considered as inappropriate by the other research doctors based on the medical backgrounds.
4)Under 20 years old

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Koichi Akashi

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Medicine and Biosystemic Science

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

0926425225

Email

hniiro@med.kyushu-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Hiroaki Niiro

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Medicine and Biosystemic Science

Zip code

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

TEL

0926425233

Homepage URL

Email

hniiro@med.kyushu-u.ac.jp

Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name

Funding Source

Organization

Kyushu University

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 04 Month 22 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

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

Enrolling by invitation

Date of protocol fixation

2012 Year 01 Month 31 Day

Date of IRB

Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Prospective study

Management information

Registered date

2015 Year 04 Month 22 Day

Last modified on

2015 Year 04 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019886

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name