UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001200
Receipt number R000001464
Scientific Title Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy
Date of disclosure of the study information 2009/09/01
Last modified on 2014/06/24 14:39:05

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Basic information

Public title

Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy

Acronym

Pulmonary infection and immunosuppressive therapy in rheumatic diseases

Scientific Title

Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy

Scientific Title:Acronym

Pulmonary infection and immunosuppressive therapy in rheumatic diseases

Region

Japan


Condition

Condition

rheumatoid arthritis (including rheumatoid arthritis with vasculitis), systemic lupus erythematosus, polymyositis, dermatomyositis, systemic sclerosis, mixed connective tissue disease, vasculitis syndrome, primary Sjogren's syndrome, Bechet disease, adult onset Still's disease

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To identify predictive factors of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Predictive factors of pulmonary infections

Key secondary outcomes

Association of pulmonary infection with survival rate
Implementation and effectiveness of prophylaxis for Pneumocystis pneumonia
Implementation and effectiveness of prophylaxis for M. tuberculosis
Implementation and effectiveness of vaccination for Streptococcus pneumoniae


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients must meet the following criteria to be eligible for study entry:
1.Have diagnosis of rheumatoid arthritis (including rheumatoid arthritis with vasculitis), systemic lupus erythematosus, polymyositis, dermatomyositis, systemic sclerosis, mixed connective tissue disease, vasculitis syndrome, primary Sjogren's syndrome, Bechet disease, or adult onset Still's disease.
2.Admit to medical centers which participate in this study.
3.Have ability and willingness to provide written informed consent and to comply with the requirement of the protocol.
4.Patients must
Start new treatment with corticosteroid or increase dosages, or
Start new treatment with immunosuppressant (azathioprine, methotrexate, cyclophosphamide, tacrolimus, ciclosporin, mizoribine, or leflunomide), switch immunosuppresant or increase dosages,
Start new treatment with biologics (infliximab, etanercept, adalimumab, rituximab or tocilizumab), switch biologics.

Key exclusion criteria

1.When patients withdraw consent to join the study.
2.When an attending doctor judges that enrollment of a patient is inappropriate
3.When patients participate in a clinical trial for approval of a drug in Japan.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Miyasaka

Organization

Tokyo Medical and Dental University

Division name

Department of Medicine and Rheumatology

Zip code


Address

1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan

TEL

03-5803-5201

Email

miya.rheu@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masayoshi Harigai

Organization

Tokyo Medical and Dental University

Division name

Department of Pharmacovigilance Medicine and Rheumatology

Zip code


Address

1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan

TEL

03-5803-4677

Homepage URL


Email

mharigai.mpha@tmd.ac.jp


Sponsor or person

Institute

Department of Medicine and Rheumatology, Tokyo Medical and Dental University Graduate School

Institute

Department

Personal name



Funding Source

Organization

Research group for reassessment and new development of diagnosis and treatment for life-limiting pulmonary comorbidities in patients with rheumatic diseases

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

2009 Year 09 Month 01 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

None

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

2008 Year 06 Month 09 Day

Date of IRB


Anticipated trial start date

2008 Year 06 Month 01 Day

Last follow-up date

2011 Year 06 Month 01 Day

Date of closure to data entry

2011 Year 07 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded

2012 Year 03 Month 01 Day


Other

Other related information

For the primany endpoint, we will identify predictive factors among baseline data for pulmonary infection using univariable and multi-variable analysis.
For the secondary endpoint, effect of pulmonary infection on short-term (2 years) life prognosis will be analyzed using multi-variable analysis, Kaplan-Meier method and Logrank method.


Management information

Registered date

2008 Year 06 Month 19 Day

Last modified on

2014 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001464


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name