UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025229 |
|---|---|
| Receipt number | R000029021 |
| Scientific Title | Study of TNFalpha antagonists against neurosarcoidosis |
| Date of disclosure of the study information | 2016/12/12 |
| Last modified on | 2021/12/16 11:58:37 |
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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
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
naoki@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
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
| 2021 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029021
