UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014485 |
|---|---|
| Receipt number | R000016456 |
| Scientific Title | Golimumab study for development of tight control and biologics-free condition. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2020/07/10 10:30:10 |
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Basic information
Public title
Golimumab study for development of tight control and biologics-free condition.
Acronym
Go-sunrising study
Scientific Title
Golimumab study for development of tight control and biologics-free condition.
Scientific Title:Acronym
Go-sunrising study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the efficacy of golimumab induce low desease activity and futher bio-free condition at 52 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Nubmer of patients who are in the low disease activity at 52 weeks.
2.Number of golimumab-free patients who are in the low disease activity after at 52 weeks.
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
Treatment with Golimumab for patients with rheumatoid arthritis
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. 20 years old or more than 20 years old.
2. Patients who are in the condition of medium disease activity even treated with MTX 6 mg per week or more than 6 mg per week or with other biologics.
3. Patients whose lab data are WBC more than 4000,lymphocyte more than 1000 and negative result of Beta D glucan.
4.Patients fully understand and agree with this study with a consent letter.
Key exclusion criteria
1.Patients who have history of allergy for golimumab.
2.Patients who have sepsis, severe infection,active tuberculosin infection, congestive heart disease, active B type viral hepatitis,nontuberculous mycobacterial infection, malignant disorders.
3.Patients who are not adequate for this study judged by investigator of this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Kobayashi |
Organization
Juntendo University School of Medicine, Juntendo Koshigaya Hospital
Division name
Rheumatology, Internal Medicine
Zip code
Address
560 Fukuroyama Koshigaya Saitama
TEL
048-975-0321
shigeto@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Kobayashi |
Organization
Juntendo University School of Medicine, Juntendo Koshigaya Hospital
Division name
Rheumatology, Internal Medicine
Zip code
Address
560 Fukuroyama Koshigaya Saitama
TEL
048-975-0321
Homepage URL
shigeto@juntendo.ac.jp
Sponsor or person
Institute
Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital
Institute
Department
Personal name
Funding Source
Organization
Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 12 | Month | 01 | 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
| 2013 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016456
