UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010033
Receipt number R000011736
Scientific Title To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy
Date of disclosure of the study information 2013/02/14
Last modified on 2018/09/13 11:05:58

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Basic information

Public title

To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy

Acronym

To investigate the efficacy of tocilizumab in RA patients with moderate disease activity

Scientific Title

To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy

Scientific Title:Acronym

To investigate the efficacy of tocilizumab in RA patients with moderate disease activity

Region

Japan


Condition

Condition

Rheumatoid Arthritis

Classification by specialty

Clinical immunology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the remission or low disease activity of tocilizumab therapy in RA patients with moderate disease activity under biologic therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Low disease activity rate at 24 weeks (SDAI)

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

Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patients between 20 and 75 years old
2)Patients with rheumatoid arthritis
3)Patients with low to moderate activity activity under more than 24 weeks of anti-tumour necrosis factor biologic therapy
4)Moderate disease activity by SDAI
5)The patient by whom consent is got in written form about participation of the final examination

Key exclusion criteria

1)Patients who have serious infection
2)Patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
3)Patients who have history of a malignant tumor, or who have malignant tumor
4)Patients who have serious cardiac disease or liver disease, renal damage
5)Pregnant women or women trying to get pregnant
6)Patients considered inappropriate judged by attending physicians

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daihei Kida

Organization

Nagoya Medical Center, National Hospital Organization in Japan

Division name

Department of Orthopaedic Surgery and Rheumatology

Zip code


Address

4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Nagoya Medical Center, National Hospital Organization in Japan

Division name

Department of Orthopaedic Surgery and Rheumatology

Zip code


Address

4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Daihei Kida

Institute

Department

Personal name



Funding Source

Organization

Nagoya Medical Center, National Hospital Organization in Japan

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

2013 Year 02 Month 14 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

Terminated

Date of protocol fixation

2013 Year 01 Month 28 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 02 Month 14 Day

Last modified on

2018 Year 09 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011736


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name