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

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 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


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

Value
https://center6.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