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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002110
Receipt No. 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

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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
Institute University of Occupational & Environmental Health, Japan
Institute
Department

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
URL(English) https://upload.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


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