UMIN-CTR Clinical Trial

Public title

Multicenter cohort study on the perioperative adverse events with orthopedic surgery associated with abatacept

Acronym

Perioperative complications with abatacept

Scientific Title

Multicenter cohort study on the perioperative adverse events with orthopedic surgery associated with abatacept

Scientific Title:Acronym

Perioperative complications with abatacept

Region

Japan

Condition

rheumatoid arthritis

Classification by specialty

Clinical immunology

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of abatacept on the preoperative complications of orthopedic surgery in a multi center cohort.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

the occurrence ratio of surgical site infection

Key secondary outcomes

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) rheumatoid arthritis patients diagnosed by the classification criteria of ACR 1987 or ACR/EULAR 2010
2) patients who received abatacept for rheumatoid arthritis, underwent orthopedic surgery during April 2011 to March 2014, and were followed-up for 12 months

Key exclusion criteria

1) patients who received bDMARD other than abatacept within 6 months before the operation
2) patients who have history of infection on the operated joint
3) operation other than orthopedic surgery
4) follow-up period less than 12 months
5) missing or insufficient data
6) patients who did not show consent for this study

Target sample size

200

Name of lead principal investigator

1st name	Hiromu
Middle name
Last name	Hiromu

Organization

Kyoto University Hospital

Division name

Orthopaedic Surgery

Zip code

6065312

Address

54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan

TEL

075-751-3366

Email

hiromu@kuhp.kyoto-u.ac.jp

Name of contact person

1st name	Hiromu
Middle name
Last name	Hiromu

Organization

Kyoto University Hospital

Division name

Orthopaedic Surgery

Zip code

6065312

Address

54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan

TEL

075-751-3366

Homepage URL

Email

hiromu@kuhp.kyoto-u.ac.jp

Institute

Kyoto University Hospital

Institute

Department

Personal name

Organization

Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyoto University Graduate School and Faculty of Medicine, Ethics Committee

Address

Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan

Tel

075-753-4680

Email

echcom@kuhp.kyoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

11

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000026608

Publication of results

Unpublished

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000026608

Number of participants that the trial has enrolled

1953

Results

There were no statistical significances of incident rates of wound healing delay between stopping and non-stopping groups of biological DMARDs.

Results date posted

2023

Year

01

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

We collected and analyzed 1953 patients in this study. Males were 177, and females were 1774. The averages of age, disease duration, preoperative DAS28-CRP were 71.8, 18.6, and 2.84, respectively. Patients of high, moderate, and low disease activity, and remission were 181, 718, 390, and 583, respectively.

Participant flow

We collected the data of RA patients who underwent orthopedic surgeries in participating institutions between April, 2011 and March, 2017.

Adverse events

There was no unknown adverse event.

Outcome measures

patients' demographic data and postoperative adverse events

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

06

Month

24

Day

Date of IRB

2018

Year

10

Month

30

Day

Anticipated trial start date

2016

Year

08

Month

01

Day

Last follow-up date

2018

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1, demographic data
2, disease activity
3, medication
4, the amount, interval, and stopping interval of abatacept
5, operated site and operation
6, adverse events (SSI, delayed wound healing, DVT, flare-up, death, and others

Registered date

2016

Year

07

Month

08

Day

Last modified on

2023

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026608