UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028875
Receipt number R000032911
Scientific Title The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis who achieve low disease activity
Date of disclosure of the study information 2017/09/01
Last modified on 2023/09/06 16:15:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis who achieve low disease activity

Acronym

The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis

Scientific Title

The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis who achieve low disease activity

Scientific Title:Acronym

The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis

Region

Japan


Condition

Condition

Rheumatoid Arthritis

Classification by specialty

Medicine in general Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the bone and cartilage damage after reducee and cease MTX dose for RA patients whom were prescribing MTX and their disease activity less than the degree of low class is maintaining over 24 or more weeks (DAS28-CRP < 2.7)

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the bone and cartilage damage (total sharp Score) after one year

Key secondary outcomes

Disease activity Score(DAS)-CRP, DAS28-ESR, CDAI, SDAI and HAQ


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

We assess the bone and cartilage damage after reduce and cease MTX dose for RA patients whom were prescribing MTX and their disease activity less than the degree of low class is maintaining over 24 or more weeks (DAS28-CRP < 2.7)

Key exclusion criteria

All participants underwent US examination using both greyscale and power Doppler (PD) technique. We exclude the Patients who have joint soft tissue inflammation over Grade 1 by PDUS method.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Kou
Middle name
Last name Katayama

Organization

ASAHIKAWA Medical University

Division name

Orthopedics

Zip code

0788510

Address

1-1 Midorigaoka 2 jo 1 chome Asahikawa

TEL

0166-65-2111

Email

kou@kata-rheum.or.jp


Public contact

Name of contact person

1st name Kou
Middle name
Last name Katayama

Organization

Katayama Seikeigeka Rheumatism Clinic

Division name

Rheumatology

Zip code

0788510

Address

5-17 Toyooka 13 jo 4 chome Asahikawa

TEL

0166-39-1155

Homepage URL


Email

kou@kata-rheum.or.jp


Sponsor or person

Institute

Asahikawa medical University

Institute

Department

Personal name



Funding Source

Organization

Katayama Seikeigeka Rheumatism Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Sapporo Rheumatology and immunology clinic

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Katayama orthopedic rheumatology clinic

Address

Toyooka13-4-5-17,Asahikawa

Tel

0166-39-1155

Email

kou@kata-rheum.or.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

17036

Org. issuing International ID_1

Asahikawa medical University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 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


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

2017 Year 08 Month 07 Day

Date of IRB

2017 Year 08 Month 17 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2019 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We assess the bone and cartilage damage after reduce and cease MTX dose for RA patients whom were prescribing MTX and their disease activity less than the degree of low class is maintaining over 24 or more weeks (DAS28-CRP < 2.7)


Management information

Registered date

2017 Year 08 Month 29 Day

Last modified on

2023 Year 09 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032911


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name