UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013757 |
|---|---|
| Receipt number | R000016057 |
| Scientific Title | Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study- |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2016/04/11 09:04:58 |
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Basic information
Public title
Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study-
Acronym
FRABR-ABT02
Scientific Title
Prospective observational study on anti-CCP antibody titer and clinical effect of abatacept (orencia) on patients with rheumatoid arthritis -A pilot study-
Scientific Title:Acronym
FRABR-ABT02
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a appropriate usage of abatacept (Orencia) collecting anti-CCP antibody titer values as a predictive factor of clinical improvement effect in practice use of abatacept in the study participation cites of Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between pre anti-CCP antibody titer and baseline change of SDAI at 24wks, 52wks and 104wks after abatacept administration.
Key secondary outcomes
1) Relationship between pre anti-CCP antibody titer and baseline change of DAS28-ESR and DAS28-CRP at 24wks, 52wks and 104wks after abatacept administration.
2) Relationship between pre anti-CCP antibody titer and baseline change of QOL improvement effect by using mHAQ at 24wks, 52wks and 104wks after abatacept administration.
3) Baseline change of ant-CCP antibody titer and RF at 12wks, 24wks, 52wks, 76wks and 104months after abatacept administration.
4) Baseline change of MMP-3 at 12wks, 24wks, 52wks, 76wks and 104wks after abatacept administration.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Both genders at more than 20 years old.
2) Patients providing written informed consent.
3) Patients with administration of abatacept (orencia) as a treatment of rheumatoid arthritis.
Note1: Give it when an effect is insufficient, even if an appropriate treatment with at least one anti-rheumatic drug is performed in past treatment.
Note2: Do not use anti-TNF antibody together with this drug. In addition, avoid combination because the effectiveness and the safety about combination of this drug and other biologics (BIO) are not established.
Key exclusion criteria
1) Patients with history of hypersensitivity to the content of abatacept.
2) Patients with severe infection.
3) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Kondo |
Organization
Kondo Clinic of Rheumatism and Orthopedics
Division name
Department of Orthopedics
Zip code
Address
Tenjin 3-10-11, Chuo-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-762-2380
kondo-m@c.email.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Tsuru |
Organization
PS Clinic
Division name
Department of Rheumatology
Zip code
Address
Tenyamachi 6-18, Hakata-ku,
TEL
092-283-7777
Homepage URL
tomomi-tsuru@lta-med.com
Sponsor or person
Institute
Fukuoka Rheumatoid Arthritis Biologics Registry (FRABR)
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
近藤リウマチ・整形外科クリニック（福岡県）
ピーエスクリニック（福岡県）
北九州市立医療センター（福岡県）
九州医療センター（福岡県）
九州大学病院（福岡県）
久留米大学医療センター（福岡県）
国立病院機構福岡病院（福岡県）
生野リウマチ整形外科クリニック（福岡県）
杉岡記念病院（福岡県）
博愛会病院（福岡県）
浜の町病院（福岡県）
福岡赤十字病院（福岡県）
福岡大学筑紫病院（福岡県）
福岡大学病院（福岡県）
福岡豊栄会病院（福岡県）
福西会病院（福岡県）
前川リウマチ科整形外科クリニック（福岡県）
宗像医師会病院（福岡県）
諸岡整形外科病院（福岡県）
和田整形外科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 18 | 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
Completed
Date of protocol fixation
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate a appropriate usage of abatacept (Orencia) collecting anti-CCP antibody titer values as a predictive factor of clinical improvement effect in practice use of abatacept.
Management information
Registered date
| 2014 | Year | 04 | Month | 18 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016057
