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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015175
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
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 1-16-2 Sugao,Miyamae-ku,Kawasaki-shi,Kanagawa-ken,japan
TEL 044-977-8111
Homepage URL
Email mamiko.shimizu@marianna-u.ac.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017646


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