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 |
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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
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
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
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
