Unique ID issued by UMIN | UMIN000014109 |
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Receipt number | R000016124 |
Scientific Title | FUKUOKA RA study for joint preserving effects with ACTEMRA |
Date of disclosure of the study information | 2014/05/29 |
Last modified on | 2014/06/30 08:06:37 |
FUKUOKA RA study for joint preserving effects with ACTEMRA
F-ACT Study
FUKUOKA RA study for joint preserving effects with ACTEMRA
F-ACT Study
Japan |
Rheumatoid Arthritis
Clinical immunology | Orthopedics |
Others
NO
The purpose of this research is to study joint preserving effects under the clinical practice by hypodermic infection (Trade name: ACTEMRA 162mg Syringe for SC Injection / ACTEMRA 162mg Auto-Infector for SC Injection with RA patients.
Safety,Efficacy
Amount of change of joint preserving effects (Yearly progression) as at 52 weeks by vdH-modified Total Sharp Score from before the administration.
Observational
Not applicable |
Not applicable |
Male and Female
1. The patient who is diagnosed as rheumatoid arthritis according to ACR/EULAR new classification criteria in 2010.
2. The patient who is in the treatment of more than 1 kind of former DMARDs.
3. The patient who has Disease activity score 28 (DAS28-ESR)>=3.2
4. The patient who has never used tocilizumab before.
5. The patients whose attending doctor diagnoses that the treatment of biomedicine is valid according to the guideline of biomedicine use for RA of Japan College of Rheumatology.
6. The patient who wants TCZ-SC treatment.
7. The patient who gave his/her written consent to participation in this research.
1. If the medicine in this research is contraindicated for the patient.
2. When the research PI or physician-in-charge diagnoses the patient is unsuitable for the research.
110
1st name | |
Middle name | |
Last name | Masakazu Kondo |
Fukuoka RA Biologics Registry
office
Tenjin 3-10-11, Chuou-ku, Fukuoka-shi, Fukuoka
092-762-2280
kondo-clinic@clinicalsupport.co.jp
1st name | |
Middle name | |
Last name | Masakazu Kondo |
Fukuoka RA Biologics Registry
office
Tenjin 3-10-11, Chuou-ku, Fukuoka-shi, Fukuoka
092-762-2280
kondo-clinic@clinicalsupport.co.jp
Fukuoka RA Biologics Registry
CHUGAI PHARMACEUTICAL CO., LTD
Profit organization
NO
2014 | Year | 05 | Month | 29 | Day |
Unpublished
Open public recruiting
2014 | Year | 04 | Month | 15 | Day |
2014 | Year | 06 | Month | 01 | Day |
multicenter prospective observational study
2014 | Year | 05 | Month | 29 | Day |
2014 | Year | 06 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016124
Research Plan | |
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Research case data | |
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