UMIN-CTR Clinical Trial

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
Email	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
Email	shigeto@juntendo.ac.jp

Sponsor
Institute	Rheumatology, Internal MedicineJuntendo University School of Medicine, Juntendo Koshigaya Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016456