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 |
* 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
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
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
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
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
