UMIN-CTR Clinical Trial

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
Last 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
1st 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