UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study-
Title of the study (Brief title)	FRABR-ABT02
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Medicine in general Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate a appropriate usage of abatacept (Orencia) collecting anti-CCP antibody titer values as a predictive factor of clinical improvement effect in practice use of abatacept in the study participation cites of Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between pre anti-CCP antibody titer and baseline change of SDAI at 24wks, 52wks and 104wks after abatacept administration.
Key secondary outcomes	1) Relationship between pre anti-CCP antibody titer and baseline change of DAS28-ESR and DAS28-CRP at 24wks, 52wks and 104wks after abatacept administration. 2) Relationship between pre anti-CCP antibody titer and baseline change of QOL improvement effect by using mHAQ at 24wks, 52wks and 104wks after abatacept administration. 3) Baseline change of ant-CCP antibody titer and RF at 12wks, 24wks, 52wks, 76wks and 104months after abatacept administration. 4) Baseline change of MMP-3 at 12wks, 24wks, 52wks, 76wks and 104wks after abatacept administration.

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	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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) Both genders at more than 20 years old. 2) Patients providing written informed consent. 3) Patients with administration of abatacept (orencia) as a treatment of rheumatoid arthritis. Note1: Give it when an effect is insufficient, even if an appropriate treatment with at least one anti-rheumatic drug is performed in past treatment. Note2: Do not use anti-TNF antibody together with this drug. In addition, avoid combination because the effectiveness and the safety about combination of this drug and other biologics (BIO) are not established.
Key exclusion criteria	1) Patients with history of hypersensitivity to the content of abatacept. 2) Patients with severe infection. 3) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size	50

Research contact person
Name of lead principal investigator	Masakazu Kondo
Organization	Kondo Clinic of Rheumatism and Orthopedics
Division name	Department of Orthopedics
Address	Tenjin 3-10-11, Chuo-ku, Fukuoka-city, Fukuoka, Japan
TEL	092-762-2380
Email	kondo-m@c.email.ne.jp

Public contact
Name of contact person	Tomomi Tsuru
Organization	PS Clinic
Division name	Department of Rheumatology
Address	Tenyamachi 6-18, Hakata-ku,
TEL	092-283-7777
Homepage URL
Email	tomomi-tsuru@lta-med.com

Sponsor
Institute	Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)
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	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	近藤リウマチ・整形外科クリニック（福岡県） ピーエスクリニック（福岡県） 北九州市立医療センター（福岡県） 九州医療センター（福岡県） 九州大学病院（福岡県） 久留米大学医療センター（福岡県） 国立病院機構福岡病院（福岡県） 生野リウマチ整形外科クリニック（福岡県） 杉岡記念病院（福岡県） 博愛会病院（福岡県） 浜の町病院（福岡県） 福岡赤十字病院（福岡県） 福岡大学筑紫病院（福岡県） 福岡大学病院（福岡県） 福岡豊栄会病院（福岡県） 福西会病院（福岡県） 前川リウマチ科整形外科クリニック（福岡県） 宗像医師会病院（福岡県） 諸岡整形外科病院（福岡県） 和田整形外科医院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 07 Day
Anticipated trial start date	2014 Year 03 Month 03 Day
Last follow-up date	2018 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To investigate a appropriate usage of abatacept (Orencia) collecting anti-CCP antibody titer values as a predictive factor of clinical improvement effect in practice use of abatacept.

Management information
Registered date	2014 Year 04 Month 18 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000016057