UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013885 |
|---|---|
| Receipt number | R000016198 |
| Scientific Title | Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study |
| Date of disclosure of the study information | 2014/05/05 |
| Last modified on | 2014/05/05 12:56:58 |
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Basic information
Public title
Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study
Acronym
Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study
Scientific Title
Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study
Scientific Title:Acronym
Evaluation of cardiac risk in rheumatoid arthritis patients befoer and after treatment of Biologics in retrospective study
Region
| Japan |
Condition
Condition
rheumatoid arthiritis
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Individuals with rheumatoid arthritis (RA) have a 1.5-2.0 fold higher risk of developing congestive heart failure than the general population. Small increases in N-terminal pro-brain natriuretic peptide (NT-proBNP) level are predictor of left ventricular dysfunction and high levels signal left ventricular dysfunction.. Data on the effects of Biologics agents on cerculating NT-proBNP levels with active RA patients are lacking but may be informative.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of NT-pro BNP after treatment at 24 weeks of Biologics.
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
RA patients were scheduled to receive TCZ once a month after 24 weeks. Serum NT-pro BNP concentrations were measured simultaneously on stored baseline and 24 week samples.
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
Consecutive RA patients with active disease without a clinical diagnosis of cardiovascular disease were enrolled. The RA patients each had inadequate clinical response to non-biologic DMARDs. RA patients were scheduled to receive Biologics after 24 weeks
Key exclusion criteria
Exclusion criteria were diabetes, previous cardiovascular events, cardiopathy, hypertension and renal disease.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kobayashi Hitomi |
Organization
Itabashi Chuo Medical Center
Division name
rheumatology
Zip code
Address
2-12-7 Azusawa Itabashi-ku Tokyo Japan
TEL
03-3967-1181
haraoka@pero.name
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isamu Yokoe |
Organization
Itabashi Chuo Medical Center
Division name
Rheumtology
Zip code
Address
2-12-7 Azusawa Itabashi-ku Tokyo Japan
TEL
03-3967-0572
Homepage URL
pero1995@gmail.com
Sponsor or person
Institute
Itabashi Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Itabashi Chuo Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 05 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 05 | Day |
Last modified on
| 2014 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016198
