UMIN-CTR Clinical Trial

Public title

Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study-

Acronym

FRABR-ABT02

Scientific Title

Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study-

Scientific Title:Acronym

FRABR-ABT02

Region

Japan

Condition

Rheumatoid Arthritis

Classification by specialty

Medicine in general	Clinical immunology	Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Masakazu Kondo

Organization

Kondo Clinic of Rheumatism and Orthopedics

Division name

Department of Orthopedics

Zip code

Address

Tenjin 3-10-11, Chuo-ku, Fukuoka-city, Fukuoka, Japan

TEL

092-762-2380

Email

kondo-m@c.email.ne.jp

Name of contact person

1st name
Middle name
Last name	Tomomi Tsuru

Organization

PS Clinic

Division name

Department of Rheumatology

Zip code

Address

Tenyamachi 6-18, Hakata-ku,

TEL

092-283-7777

Homepage URL

Email

tomomi-tsuru@lta-med.com

Institute

Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)

Institute

Department

Personal name

Organization

Clinical Research Support Center Kyushu

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2014

Year

04

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

02

Month

07

Day

Date of IRB

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

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.

Registered date

2014

Year

04

Month

18

Day

Last modified on

2016

Year

04

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016057