UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023088
Receipt No. R000026608
Scientific Title Multicenter cohort study on the perioperative adverse events with orthopedic surgery associated with abatacept
Date of disclosure of the study information 2016/07/11
Last modified on 2019/07/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes the occurrence ratio of surgical site infection
Key secondary outcomes

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

Eligibility
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

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiromu Ito
Organization Kyoto University Hospital
Division name Orthopaedic Surgery
Zip code
Address 54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL 075-751-3366
Email seikei@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiromu Ito
Organization Kyoto University Hospital
Division name Orthopaedic Surgery
Zip code
Address 54 Kawahara-cho, Shogoin,Sakyo, Kyoto 606-8507, Japan
TEL 075-751-3366
Homepage URL
Email seikei@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.,LTD.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 07 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
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
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

Management information
Registered date
2016 Year 07 Month 08 Day
Last modified on
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026608

Research Plan
Registered date File name
2018/01/09 オレンシア周術期研究 期間延長(最終版).doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.