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 | 2026/01/04 13:26:22 |
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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 | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
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 | Kazuyoshi |
| Middle name | |
| Last name | Saito |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
807-8555
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
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu
Tel
093-603-1611
daigakukanri@mbox.pub.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
| 2009 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
https://ard.bmj.com/content/annrheumdis/69/7/1286.full.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://ard.bmj.com/content/annrheumdis/69/7/1286.full.pdf
Number of participants that the trial has enrolled
114
Results
Among 114 patients with rheumatoid arthritis (mean disease duration 5.9 years, DAS28 5.5, mTSS 63.3), infliximab was discontinued after maintaining low disease activity for more than 24 weeks, and outcomes were evaluated at 1 year. Of the 102 evaluable patients, 55% maintained DAS28 <3.2 and 43% achieved remission. In the 46 patients who failed to achieve remission, disease flares and higher disease activity were more frequent, with greater radiographic progression and functional impairment.
Results date posted
| 2026 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The demographic and baseline characteristics of the 114 enrolled patients were as follows: the mean age was 51.4 years, the mean disease duration was 5.9 years, and the mean modified total Sharp score (mTSS) was 63.3, indicating that the cohort included patients with long-established rheumatoid arthritis. The mean DAS28 (ESR) was 5.5, suggesting that most patients had high disease activity at baseline.
Participant flow
This study was a simple observational study after discontinuation of infliximab. Patients were followed for 2 years, with symptoms, physical findings, and DAS28 ESR assessed every 4 to 13 weeks. The dose of concomitant methotrexate was basically maintained, while tapering of NSAIDs and glucocorticoids was allowed. The primary endpoints were maintenance of DAS28 less than 3 point 2 for 1 year after discontinuation and annual progression of mTSS less than 0 point 5. In cases of disease flare, infliximab was restarted at the same dose, and such patients were classified into the RRR failed group.
Adverse events
Minimal infusion-related adverse reactions were observed in five patients, occurring only during the first or second infusion.
Outcome measures
The primary end points were that after discontinuing infl iximab, DAS28 remains <3.2 (LDA) for 1 year and yearly progression of mTSS remains <0.5 (structural remission) for 1 year.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2006 | Year | 06 | Month | 15 | Day |
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
| 2026 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002571
