UMIN-CTR Clinical Trial

Basic information
Public title	A Retrospective Analysis on Relationship between Autoantibody Profile of Rheumatoid Arthritis Patients Registered in Tsurumai Biologics Communication Registry (TBCR) and Effects/Safety of Abatacept
Acronym	Relationship between autoantibody profile of rheumatoid arthritis patients and clinical outcomes of abatacept
Scientific Title	A Retrospective Analysis on Relationship between Autoantibody Profile of Rheumatoid Arthritis Patients Registered in Tsurumai Biologics Communication Registry (TBCR) and Effects/Safety of Abatacept
Scientific Title:Acronym	Relationship between autoantibody profile of rheumatoid arthritis patients and clinical outcomes of 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 relationship between anti-cyclic cirullinated peptide antibody (ACPA) positivity and clinical outcomes of abatacept in rheumatoid arthritis using data from a multicenter registry system (TBCR).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of patients that achieved SDAI remission criteria at 52 weeks in rheumatoid arthritis patients with and without ACPA positivity treated with abatacept.
Key secondary outcomes	Progression of joint destruction in rheumatoid arthritis patients with and without ACPA positivity treated with abatacept Safety profile of abatacept treatment in rheumatoid arthritis patients with and without pulmonary comorbidity.

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	I) Rheumatoid arthritis patients that that met the 2010 ACR/EULAR RA classification criteria ii) Patients treated with abatacept under patients' doctor's decision and followed for at least 1 year. iii) Patients with data of anti-CCP antibody titer measured before starting abatacept treatment.
Key exclusion criteria	Patients who were considered not to be eligible for this study.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Nobunori Middle name Last name Takahashi
Organization	Nagoya University Hospital
Division name	Orthopaedic Surgery
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-741-2111
Email	nobunori@med.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Nobunori Middle name Last name Takahashi
Organization	Nagoya University Hospital
Division name	Orthopaedic Surgery
Zip code	466-8550
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL	052-741-2111
Homepage URL
Email	nobunori@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Hospital
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb
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	Nagoya University Hospital Ethics Committee
Address	65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel	052-741-2111
Email	ethics@med.nagoya-u.ac.jp

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	2019 Year 08 Month 01 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	400
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 12 Month 28 Day
Date of IRB	2017 Year 02 Month 14 Day
Anticipated trial start date	2017 Year 01 Month 14 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Disease activity of rheumatoid arthritis at baseline, 52, and 104 weeks are evaluated to study the relationship between ACPA positivity and effectiveness of abatacept. To evaluate the safety profile of abatacept, discontinuation rate due to adverse events is calculated by using Kaplan-Meier method.

Management information
Registered date	2019 Year 08 Month 01 Day
Last modified on	2019 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042835