UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006956
Receipt number R000008214
Scientific Title Efficacy and safety of tocilizumab in RA patients in daily clinical practice: An retrospective observational study
Date of disclosure of the study information 2011/12/27
Last modified on 2019/07/02 13:57:02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Efficacy and safety of tocilizumab in RA patients in daily clinical practice: An retrospective observational study

Acronym

REtrospective ACTemra Investigation for Optimal Needs of RA patients study

Scientific Title

Efficacy and safety of tocilizumab in RA patients in daily clinical practice: An retrospective observational study

Scientific Title:Acronym

REtrospective ACTemra Investigation for Optimal Needs of RA patients study

Region

Japan


Condition

Condition

Rheumatoid Arthritis

Classification by specialty

Medicine in general Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of achievement of clinical, structural and functional remission and the possibility of maintenance with tocilizumab in daily clinical practice.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Percentages of three different remissions; clinical remission (the disease activity score using the 28 joint count [DAS28]-ESR<2.6), structural remission (modified total Sharp score [mTSS]=/<0.5), and functional remission (health assessment questionnaire [HAQ]=/<0.5) at week 104 after tocilizumab treatment.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)RA patients who fulfilled the ACR classification criteria.
2)RA patients administered tocilizumab for the first time between April 2008 and March 2009.

Key exclusion criteria

Patients who had functional class4 using Steinbrocker criteria.

Target sample size

250


Research contact person

Name of lead principal investigator

1st name Yoshiya
Middle name
Last name Tanaka

Organization

University of Occupational and Environmental Health, Japan

Division name

The First Department of Internal Medicine, School of Medicine

Zip code

807-8555

Address

1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan

TEL

093-603-1611

Email

tanaka@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name KAZUHISA
Middle name
Last name NAKANO

Organization

University of Occupational and Environmental Health, Japan

Division name

The First Department of Internal Medicine, School of Medicine

Zip code

807-8555

Address

1-1 Iseigaoka, Yahatanishiku

TEL

0936031611

Homepage URL


Email

kazuhisa@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan (partly), Self funding

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Keio University, Tokyo Women's Medical University, Saitama Medical Center

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan

Address

1-1 Iseigaoka, Yahatanishiku, Kitakyushu

Tel

093-603-1611

Email

daigakukanri@mbox.pub.uoeh-u.ac.jp


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

産業医科大学・東京女子医科大学附属膠原病リウマチ痛風センター・埼玉医科大学病院総合医療センター・慶應義塾大学医学部内科学教室


Other administrative information

Date of disclosure of the study information

2011 Year 12 Month 27 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2008 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 04 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

Percentages of three different remissions; clinical remission (DAS28-ESR<2.6), structural remission (mTSS&#8804;0.5), and functional remission (HAQ&#8804;0.5) at week 104 after tocilizumab treatment.


Management information

Registered date

2011 Year 12 Month 26 Day

Last modified on

2019 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008214


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name