UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015175 |
|---|---|
| Receipt number | R000017646 |
| Scientific Title | Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. |
| Date of disclosure of the study information | 2014/09/17 |
| Last modified on | 2015/09/16 09:10:30 |
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Basic information
Public title
Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial.
Acronym
STAR study
Scientific Title
Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial.
Scientific Title:Acronym
STAR 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 efficacy and safety of Tocilizumab versus Abatacept for Rheumatoid arthritis in a pragmatic randomized trial, STAR study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of HAQ and CDAI remission rate at 52 weeks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Subcutaneous Tocilizumab 162mg every other week.
Interventions/Control_2
Subcutaneous Abatacept 125mg every week.
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 or older at registration.
2.Rheumatoid arthritis who fulfill the ACR/EULAR 2010 classification criteria.
3.Patients with positive anti-CCP antibodies.
4.Patients with methotrexate insufficient active rheumatoid arthritis.
5.Patients who gave a written informed consent.
6.Patients with RA duration less than 2 years.
Key exclusion criteria
1.Past history of hypersensitivity to Abatacept or Tocilizumab.
2.Serious infection.
3.Active tuberculosis.
4.Lymphocytes count less than 500/microlitter.
5.Past history of infection of HCV, HBV, HIV, or HTLV-1.
6.History of TNF inhibitor administration within three months at registration.
7.An inappropriate case for the study based on the assessment by the doctor.
Target sample size
120
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
1-16-2 Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
TEL
044-977-8111
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
1-16-2 Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
TEL
044-977-8111
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | 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
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2015 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017646
