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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013885
Receipt No. 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

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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
Email 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
Email pero1995@gmail.com

Sponsor
Institute Itabashi Chuo Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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