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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013440
Receipt No. R000015693
Scientific Title To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.
Date of disclosure of the study information 2014/03/18
Last modified on 2018/09/08

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Basic information
Public title To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.
Acronym Subcutaneous and abatacept versus intravenous abatacept.
Scientific Title To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.
Scientific Title:Acronym Subcutaneous and abatacept versus intravenous abatacept.
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to compare the efficacy and safety of subcutaneous and intravenous abatacept and was to assess whether remission would be sustained with extension of subcutaneous abatacept in patients with rheumatoid arthritis after clinical remission.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of patients completed 36 weeks with SC abatacept 2 weeks dose intervals.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 SC abatacept
Interventions/Control_2 IV abatacept
Interventions/Control_3 Extension of SC abatacept
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients who met the ACR 1987 revised criteria for the classification of RA.
2. Patients diagnosed as moderate disease activity (2.3<DAS28-CRP<4.1).
3. Anti-cyclic citrullinated peptide antibody >100 U/mL or rheumatoid factor >60 IU/mL.
Key exclusion criteria Patients were excluded if they were previously treated with biological DMARDs.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuzo Yoshida
Organization Osaka Medical College
Division name Department of Internal Medicine (I)
Zip code
Address Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL +81-72-683-1221
Email in1307@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuzo Yoshida
Organization Osaka Medical College
Division name Department of Internal Medicine (I)
Zip code
Address Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL +81-72-683-1221
Homepage URL
Email in1307@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization None
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 03 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 04 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 03 Month 17 Day
Last modified on
2018 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015693

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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