UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009435 |
|---|---|
| Receipt number | R000011089 |
| Scientific Title | Analysis of factors for Bio-free remission due to the Tight control by Remicade in rheumatoid arthritis patients. Birdie study |
| Date of disclosure of the study information | 2012/11/29 |
| Last modified on | 2021/04/05 11:57:38 |
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Basic information
Public title
Analysis of factors for Bio-free remission due to the Tight control by Remicade in rheumatoid arthritis patients. Birdie study
Acronym
Burdie study
Scientific Title
Analysis of factors for Bio-free remission due to the Tight control by Remicade in rheumatoid arthritis patients. Birdie study
Scientific Title:Acronym
Burdie study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the factors that affect the bio-free remission among patients who have been treated by infliximab and achieved simplified disease activity index (SDAI). Furthermore, to clarify the efficacy and safety of re-administration of infliximab for patients with flare-up.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Identification of risk factors for relapse during the observation period until 2021.3.31 after IFX withdrawal
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with rheumatoid arthritis
2. Patients who have been treated with infliximab
3. Patients who have achieved SDAI remission for over 24 weeks
Key exclusion criteria
Patients who already achieved remission after stopping infliximab
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koike |
Organization
Osaka City University Medical School
Division name
Center for Senile degenerative Disorders (CSDD)
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
tatsuya@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koike |
Organization
Osaka City University Medical School
Division name
Center for Senile degenerative Disorders (CSDD)
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
Homepage URL
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University Graduate School of Medicine
Address
Abenoku Asahimachi 1-4-3, Osaka 545-8585, Japan
Tel
06-6645-3435
ethics@med.osaka-cu.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
大阪市立大学医学部附属病院(大阪府）、白浜はまゆう病院(和歌山県）、北出病院(和歌山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Observation of disease activities every 8 weeks until 56 weeks after stopping infliximab. Titer of anti-CCP antibody and the concentration of infliximab in serum were determined on the day of bio-free.
Management information
Registered date
| 2012 | Year | 11 | Month | 29 | Day |
Last modified on
| 2021 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011089
