UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002110
Receipt number R000002571
Scientific Title Discontinuation of infliximab therapy after acquisition of low disease activity by infliximab in rheumatoid arthritis study: RRR (remission induction by remicade) study
Date of disclosure of the study information 2009/06/23
Last modified on 2013/12/23 16:37:08

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Basic information

Public title

Discontinuation of infliximab therapy after acquisition of low disease activity by infliximab in rheumatoid arthritis study: RRR (remission induction by remicade) study

Acronym

Remission Induction by Remicade in RA Study (RRR study)

Scientific Title

Discontinuation of infliximab therapy after acquisition of low disease activity by infliximab in rheumatoid arthritis study: RRR (remission induction by remicade) study

Scientific Title:Acronym

Remission Induction by Remicade in RA Study (RRR study)

Region

Japan


Condition

Condition

rheumatoid arthritis

Classification by specialty

Clinical immunology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To seek the possibility of discontinuing infliximab therapy after reducing the disease activity of RA to low level and to evaluate progression of articular destruction during infliximab discontinuation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

After discontinuing infliximab, 1. DAS28 (ESR) remains <3.2 for 1 year, 2. Yearly progression of van der Heijde-modified total Sharp score (TSS) remains <0.5 for 1 year.

Key secondary outcomes

After discontinuing infliximab, 1. DAS28 (ESR) remains <3.2 for 2 year, 2. Yearly progression of van der Heijde-modified total Sharp score (TSS) remains <0.5 for 2 year.


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

Patients who meet all of the following criteria will be enrolled in this study:
1) Patients with RA diagnosed according to the criteria of the American College of Rheumatology (ACR) (1987)
2) DAS28 score remained less than 3.2 for 24 weeks and who consented to discontinuation of infliximab treatment.
3) Control with MTX for more than 12 weeks
4) more than 18 years

Key exclusion criteria

Patients who met the following criteria are excluded.
1) patients who are already in remission and do not use infliximab
2) control with less than 5mg/day of PSL
3) PSL was increased within 4 weeks before the study
4) patients who are not appropriate to the study by a doctor's judgement

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiya Tanaka

Organization

School of Medicine, University of Occupational and Environmental Health, Japan

Division name

First Department of Internal Medicine

Zip code


Address

1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan

TEL

093-603-1611

Email

tanaka@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuyoshi Saito

Organization

School of Medicine, University of Occupational and Environmental Health, Japan

Division name

First Department of Internal Medicine

Zip code


Address

1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, 807-8555, Japan

TEL

093-603-1611

Homepage URL


Email

tanaka@med.uoeh-u.ac.jp


Sponsor or person

Institute

University of Occupational & Environmental Health, Japan

Institute

Department

Personal name



Funding Source

Organization

a Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

2009 Year 06 Month 23 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


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

No longer recruiting

Date of protocol fixation

2006 Year 05 Month 25 Day

Date of IRB


Anticipated trial start date

2006 Year 07 Month 01 Day

Last follow-up date

2010 Year 06 Month 01 Day

Date of closure to data entry

2010 Year 06 Month 01 Day

Date trial data considered complete

2010 Year 12 Month 01 Day

Date analysis concluded

2010 Year 12 Month 01 Day


Other

Other related information

The study includes patients with any disease duration and disease-modifying antirheumatic drug history, but excluded patietns who had received steroids at dosages greater than 5mg/day. The average disease duration among all patients in the study is 6 years. Among 102 evaluable patients with RA who stopped infliximab after maintaining a DAS28 less than 3.2 for 24 weeks, 56 patients (55%) are able to remain off infliximab for at least 1 year by this observation study. Patients who were able to remain off infliximab for at least one year also show no radiologic progression.


Management information

Registered date

2009 Year 06 Month 23 Day

Last modified on

2013 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002571


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name