Unique ID issued by UMIN | UMIN000037572 |
---|---|
Receipt number | R000042835 |
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 |
Date of disclosure of the study information | 2019/08/01 |
Last modified on | 2019/08/01 15:46:53 |
A Retrospective Analysis on Relationship between Autoantibody Profile of Rheumatoid Arthritis Patients Registered in Tsurumai Biologics Communication Registry (TBCR) and Effects/Safety of Abatacept
Relationship between autoantibody profile of rheumatoid arthritis patients and clinical outcomes of abatacept
A Retrospective Analysis on Relationship between Autoantibody Profile of Rheumatoid Arthritis Patients Registered in Tsurumai Biologics Communication Registry (TBCR) and Effects/Safety of Abatacept
Relationship between autoantibody profile of rheumatoid arthritis patients and clinical outcomes of abatacept
Japan |
rheumatoid arthritis
Clinical immunology | Orthopedics |
Others
NO
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).
Safety,Efficacy
Proportion of patients that achieved SDAI remission criteria at 52 weeks in rheumatoid arthritis patients with and without ACPA positivity treated with abatacept.
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.
Observational
Not applicable |
Not applicable |
Male and Female
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.
Patients who were considered not to be eligible for this study.
400
1st name | Nobunori |
Middle name | |
Last name | Takahashi |
Nagoya University Hospital
Orthopaedic Surgery
466-8550
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-741-2111
nobunori@med.nagoya-u.ac.jp
1st name | Nobunori |
Middle name | |
Last name | Takahashi |
Nagoya University Hospital
Orthopaedic Surgery
466-8550
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-741-2111
nobunori@med.nagoya-u.ac.jp
Nagoya University Hospital
Bristol-Myers Squibb
Profit organization
Nagoya University Hospital Ethics Committee
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
052-741-2111
ethics@med.nagoya-u.ac.jp
NO
2019 | Year | 08 | Month | 01 | Day |
Unpublished
400
No longer recruiting
2016 | Year | 12 | Month | 28 | Day |
2017 | Year | 02 | Month | 14 | Day |
2017 | Year | 01 | Month | 14 | Day |
2020 | Year | 03 | Month | 31 | Day |
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.
2019 | Year | 08 | Month | 01 | Day |
2019 | Year | 08 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042835
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |