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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000011891
Receipt No. R000013897
Scientific Title Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis.
Date of disclosure of the study information 2013/10/01
Last modified on 2015/10/28

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Basic information
Public title Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis.
Acronym GLORIA study
Scientific Title Multicenter study of the effect of GoLimumab On the Remission Induction rate and bio-free remission maintenance rate in early rheumatoid Arthritis.
Scientific Title:Acronym GLORIA study
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the effect of Golimumab on the remission induction rate and bio-free remission maintenance rate in Japanese patients with early rheumatoid arthritis who have high disease activity and poor prognosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Remission induction rate
2.Health assessment questionare
3. Rate of no radiological progression
4. Bio-free remission maintenance rate and duration
5.Maintenance rate of low disease activity after cessation of golimumab
6.Remission induction rate after re-introduction of golimumab in patients with relapse.
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 Golimumab
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1.Rheumatoid arthritis who fulfill the 2011 ACR/EULAR classification criteria.
2.Early RA with disease duration of 6 months or less.
3.Who have at least one of the poor prognostic factors; bone erosions, high titer of anti-CCP antibodies, or HAQ score more than 1.0
4.High disease activity of CDAI score more than 22
Key exclusion criteria 1.progressive interstitial lung disease
2.HBV and/or HCV carier
3.History of any biologic DMARDs use
4.Seriou infection, active tuberculosis, demyelinating disease, or congestive heart failure
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidehiro Yamada
Organization St.Marianna University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 1-16-2Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
TEL 042-977-8111
Email soramameyamada@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamiko Shimizu
Organization St.Marianna University School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 1-16-2Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
TEL 042-977-8111
Homepage URL
Email mamiko.shimizu@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization St.Marianna University School of Medicine
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 麻生リハビリ総合病院(神奈川県)、あゆみクリニック内科・リウマチ科(神奈川県)、川崎市立井田病院(神奈川県)、川崎市立川崎病院(神奈川県)、川崎リウマチ・内科クリニック(神奈川県)、聖マリアンナ医科大学横浜市西部病院(神奈川県)、聖ヨゼフ病院(神奈川県)、光中央診療所(神奈川県)、山本整形外科医院(神奈川県)、横浜労災病院(神奈川県)、

Other administrative information
Date of disclosure of the study information
2013 Year 10 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 09 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 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
2013 Year 09 Month 27 Day
Last modified on
2015 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013897

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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