UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018414
Receipt number R000021318
Scientific Title Tocilizumab long-term extension trial in patients with adult onset still
Date of disclosure of the study information 2015/07/24
Last modified on 2019/05/22 16:55:48

* 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

Tocilizumab long-term extension trial in patients with adult onset still

Acronym

Tocilizumab long-term extension trial in patients with adult onset still

Scientific Title

Tocilizumab long-term extension trial in patients with adult onset still

Scientific Title:Acronym

Tocilizumab long-term extension trial in patients with adult onset still

Region

Japan


Condition

Condition

Adult onset still disease

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess long-term efficacy and safety in adult onset still patients enrolled in Tocilizumab clinical trial in patients with adult onset still (KCCR-D002)

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

<Safety>
Onset frequency of Adverse even and side effect

<Efficacy>
Changes of proportion of patient discontinued corticosteroid

Changes of ACR 20%, 50% and 70% improvement criteria

Change of ACR core set

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

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)Patients who completed KCCR-D002 clinical trial
2)Patients in KCCR-D002 clinical trial in who were identified adequate safety by doctors
3)Patients identified as required Tocilizumab long-term extension by a doctor
4)Patients requesting continuous administration of Tocilizumab, whose written informed consent has been obtained

Key exclusion criteria

1) Patients who have not been enrolled within 3 months since last observation in KCCR-D002 clinical trial
2)Patients having received following therapy before starting treatment since last observation in KCCR-D002 clinical trial
(1) Tocilizumab , Inflixmab, Golimumab, Adalimumab, Apatacept, Leflunomide Certolizumab pegol,Etanercept and these biosimilar
(2) DMARDs or immune-suppressing drug
(3) Cell depletion therapy
(4) Surgical treatment excluding local procedures (dental extraction or ophthalmologic laser surgery etc.
(5) Plasma exchange therapy
(6) Tocilizumab
3) Patients with serious drug allergy for Tocilizumab in KCCR-D002 clinical trials
4) Patient with current and past history of following disease and diagnosed as inapplicable to this study by a doctor, cardiovascular disease, hematologic/ hematopoietic disease, respiratory disease, neurological/muscular disorder, endocrine disease, renal/urological disease or gastroenterological disorder
5) Patients with infection within 4 weeks before initial administration in this study and diagnosed as inapplicable to this study by a doctor
6) Expectant mother, mother with breast-feeding, patient who have possibility of pregnancy or hope to be pregnant
7) Others not applicable person determined by a doctor

Target sample size

34


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuko Kaneko

Organization

Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine

Division name

Division of Rheumatology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582

TEL

03-3353-1211

Email

ykaneko@z6.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuto Fujiki

Organization

Keio University Hospital

Division name

Clinical and Translational Research Center

Zip code


Address

Clinical Research Building #111, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582

TEL

03-5315-4278

Homepage URL


Email

pmo@ccr.med.keio.ac.jp


Sponsor or person

Institute

Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Chugai Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 07 Month 24 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

Completed

Date of protocol fixation

2015 Year 04 Month 09 Day

Date of IRB

2015 Year 05 Month 29 Day

Anticipated trial start date

2015 Year 08 Month 17 Day

Last follow-up date

2019 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 07 Month 24 Day

Last modified on

2019 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name