UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014856
Receipt number R000016852
Scientific Title Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis
Date of disclosure of the study information 2014/09/01
Last modified on 2022/02/16 09:27:09

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Basic information

Public title

Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis

Acronym

FREE-J study

Scientific Title

Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis

Scientific Title:Acronym

FREE-J study

Region

Japan


Condition

Condition

rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To construct evidences for establishing a therapeutic guideline aiming at "drug holiday" in rheumatoid arthritis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

DAS28(ESR) remission rate at 1 year after discontinuing biological DMARD

Key secondary outcomes



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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patient diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis.
(2) Patient maintained stable DAS28(ESR) remission at least 2 consecutive visits under treatment with biological DMARD and concomitant MTX (8mg/week).
(3) Patient;18 year-old with written informed consent for participating in the study.

Key exclusion criteria

(1) Patient with contraindication to MTX.
(2) Patient with contraindication to biological DMARD.
(3) Patient with any other reasons for inadequate to participate in this study, judege by attending rheumatologist.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Yoshiya
Middle name
Last name Tanaka

Organization

University of Occupational and Environmental Health, Japan

Division name

The First Department of Internal Medicine

Zip code

807-8555

Address

1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan

TEL

+81-93-603-1611

Email

tanaka@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name Ayako
Middle name
Last name Yamaguchi

Organization

University of Occupational and Environmental Health, Japan

Division name

The First Department of Internal Medicine

Zip code

807-8555

Address

1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan

TEL

+81-93-603-1611

Homepage URL


Email

ayasuzu@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational and Environmental Health, Japan

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

The First Department of Internal Medicine

Address

1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan

Tel

+81-93-603-1611

Email

ayasuzu@med.uoeh-u.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

2014 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

436

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

Main results already published

Date of protocol fixation

2014 Year 06 Month 21 Day

Date of IRB

2015 Year 06 Month 09 Day

Anticipated trial start date

2014 Year 12 Month 01 Day

Last follow-up date

2020 Year 06 Month 01 Day

Date of closure to data entry

2020 Year 10 Month 01 Day

Date trial data considered complete

2020 Year 10 Month 01 Day

Date analysis concluded



Other

Other related information

If a patient with rheumatoid arthritis achieve DAS28 remission at two consequent visit, one can choose one out of five treatments below, then will be observed for two years.
1) Continue both MTX and bDMARD withouot reduction
2) Reduce MTX to a half dose
3) Withdraw MTX
4) Reduce bDMARD to a half dose
5) Withdraw bDMARD


Management information

Registered date

2014 Year 08 Month 13 Day

Last modified on

2022 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016852


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name