UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023152
Receipt number R000026686
Scientific Title To Investigate predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis
Date of disclosure of the study information 2016/07/14
Last modified on 2022/08/04 15:51:49

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Basic information

Public title

To Investigate predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis

Acronym

Predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis

Scientific Title

To Investigate predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis

Scientific Title:Acronym

Predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis

Region

Japan


Condition

Condition

Rheumatoid arthritis, Psoriatic arthritis

Classification by specialty

Clinical immunology Dermatology Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

To clarify predictors of the efficacies of biologics for rheumatoid arthritis or psoriatic arthritis

Key secondary outcomes

Correlation between functional of bone structural disease activity scores of rheumatoid arthritis or psoriatic arthritis and predictors


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 or psoriatic arthritis who are treated with a first biologic or a switching biologic
2) Patients must be able to sign the informed consent.

Key exclusion criteria

1) Patients who refuse to participate this study
2) Patients for whom the physicians do not think suitable for this study

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hiroko
Middle name
Last name Kanda

Organization

University of Tokyo

Division name

Immune-mediated Diseases Therapy Center, Graduate School of Medicine

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Email

hkanda-tky@umin.ac.jp


Public contact

Name of contact person

1st name Hiroko
Middle name
Last name Kanda

Organization

University of Tokyo

Division name

Immune-mediated Diseases Therapy Center, Graduate School of Medicine

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-3815-5411

Homepage URL


Email

hkanda-tky@umin.ac.jp


Sponsor or person

Institute

Immune-Mediated Diseases Therapy Center,
Graduate School of Medicine
University of Tokyo

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

Office for Human Research Studies

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5841-0818

Email

ethics@m.u-tokyo.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



Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 14 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

Enrolling by invitation

Date of protocol fixation

2011 Year 07 Month 25 Day

Date of IRB

2011 Year 07 Month 25 Day

Anticipated trial start date

2011 Year 07 Month 26 Day

Last follow-up date

2023 Year 07 Month 25 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We are collecting our results and start analysis of the results


Management information

Registered date

2016 Year 07 Month 13 Day

Last modified on

2022 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026686


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name