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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 25 February 2020
Main ID:  JPRN-jRCTs031180001
Date of registration: 12/06/2018
Prospective Registration: No
Primary sponsor: Ikeda Kei
Public title: Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
Scientific title: Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT
Date of first enrolment: 30/05/2016
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs031180001
Study type:  Interventional
Study design:  single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose  
Phase:  4
Countries of recruitment
Japan
Contacts
Name: Kei    Ikeda
Address:  1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677 Chiba Japan
Telephone: +81-43-222-7171
Email: K.Ikeda@faculty.chiba-u.jp
Affiliation:  Chiba University Hospital
Name: Kei    Ikeda
Address:  1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677 Chiba Japan
Telephone: +81-43-222-7171
Email: K.Ikeda@faculty.chiba-u.jp
Affiliation:  Chiba University Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1) 18 years or older
2) RA patients who fulfill 2010 ACR/EULAR Classification Criteria
3) Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
4) DAS28 (CRP) < 3.2 at screening
5) Patients who give written informed consent after receiving sufficient information

Exclusion criteria: 1) Receiving prednisolone > 10 mg/day
2) Receiving biological or molecular-target anti-rheumatic drug
3) Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
4) Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
5) History of infusion reaction to infliximab
6) Current infection which requires treatment
7) Current or previous demyelinating disorder
8) Current congestive heart failure which requires treatment
9) Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period
10) Patients whom investigator or co-investigator consider inappropriate for other reasons


Age minimum: >= 18age old
Age maximum: Not applicable
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)
Infliximab Withdrawal
Primary Outcome(s)
Difference in diagnostic value (AUC of ROC) to predict relapse between DAS28 and total PD score at baseline
Secondary Outcome(s)
Predictive values
- DAS28 at baseline
- total PD/GS scores at baseline
- clinical outcomes other than relapse
- structural progression (delta van der Heijde [vdH] Sharp score)
- physical function (Health Assessment Questionnaire-Disability Index [HAQ-DI])
- quality of life (EuroQoL 5 dimensions [EQ-5D]-5L QOL)
Efficacy and safety after re-administration of infliximab
- DAS28, EULAR response
- adverse events
Secondary ID(s)
UMIN000021929,NCT02770794
Source(s) of Monetary Support
Mitsubishi Tanabe Pharma Corporation
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date: 25/05/2018
Contact:
prc-jim@chiba-u.jp
Chiba University Certified Clinical Research Review Board
+81-43-226-2616
prc-jim@chiba-u.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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