UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.
Title of the study (Brief title)	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	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Department of Internal Medicine (I)
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	Shuzo Yoshida
Organization	Osaka Medical College
Division name	Department of Internal Medicine (I)
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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