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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017646


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name