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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025229
Receipt No. R000029021
Scientific Title Study of TNFalpha antagonists against neurosarcoidosis
Date of disclosure of the study information 2016/12/12
Last modified on 2016/12/12

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Basic information
Public title Study of TNFalpha antagonists against neurosarcoidosis
Acronym Study of TNFalpha antagonists against neurosarcoidosis
Scientific Title Study of TNFalpha antagonists against neurosarcoidosis
Scientific Title:Acronym Study of TNFalpha antagonists against neurosarcoidosis
Region
Japan

Condition
Condition neuro-sarcoidosis
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will investigate the efficacy and safety of TNFalpha antagonists against intractable neuro-sarcoidosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Recurrence of nerve sarcoidosis on spinal cord lesions.
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 Influiximab is administered intravenously at a dose of 3 mg per kg of body weight. It is administered at 2 weeks, 6 weeks after the first dose, and administered at intervals of 8 weeks thereafter.
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
50 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria One specific example is the target.
Key exclusion criteria One specific example is the target.
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Suzuki
Organization Tohoku University
Division name Hospital
Zip code
Address Sendai-shi, Aoba-ku, Seiryo-machi 1-1
TEL 022-717-7000
Email naoki@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Suzuki
Organization Tohoku University
Division name Hospital, Department of Neurology
Zip code
Address Sendai-shi, Aoba-ku, Seiryo-machi 1-1
TEL 022-717-7000
Homepage URL
Email naoki@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
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
2016 Year 12 Month 12 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 No longer recruiting
Date of protocol fixation
2016 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 12 Day
Last modified on
2016 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029021

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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