UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011891 |
|---|---|
| Receipt number | 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 10:41:50 |
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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
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
mamiko.shimizu@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013897
