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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034534
Receipt No. R000039375
Scientific Title Thalidomide for patients with severe autoimmune disease or autoinflammatory disease
Date of disclosure of the study information 2018/10/17
Last modified on 2019/04/17

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Basic information
Public title Thalidomide for patients with severe autoimmune disease or autoinflammatory disease
Acronym Thalidomide for patients with severe autoimmune disease or autoinflammatory disease
Scientific Title Thalidomide for patients with severe autoimmune disease or autoinflammatory disease
Scientific Title:Acronym Thalidomide for patients with severe autoimmune disease or autoinflammatory disease
Region
Japan

Condition
Condition Severe autoimmune disease or autoinflammatory disease who was refractory against standard treatment
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of thalidomide in patients with childhood-onset rheumatic disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes inhibition of disease activity
Key secondary outcomes improvement of physician's VAS, patient's VAS, biomarkers of disease activity and dose of corticosteroids

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 Thalidomide 50-400mg
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Registance against standerd treatment or steroid-dependent
2. No experience of thalidomide
3. Patients gave written informed consent
Key exclusion criteria 1. Pulmonary tuberculosis, active bacterial infection or deep mycotic infection
2. Infection of HIV, HCV or HBV
3. Administraion of live vaccine within 4 weeks
4. Pregnant subjects or subjects who do not agree with contraception during the study period
5. Others
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Nishimura
Organization Yokohama City University Hospital
Division name Department of Pediatrics
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL 045-787-2800
Email k_nsm@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Nishimura
Organization Yokohama City University Hospital
Division name Department of Pediatrics
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL 045-787-2800
Homepage URL
Email k_nsm@yokohama-cu.ac.jp

Sponsor
Institute Department of Pediatrics, Yokohama City University Hospital
Institute
Department

Funding Source
Organization Yokohama City University Hospital
Organization
Division
Category of Funding Organization Other
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
2018 Year 10 Month 17 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
2010 Year 08 Month 01 Day
Date of IRB
2010 Year 08 Month 01 Day
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2019 Year 04 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 17 Day
Last modified on
2019 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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