UMIN-CTR Clinical Trial

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
Last 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
1st 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
Institute	Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021318