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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: 7 September 2020
Main ID:  JPRN-UMIN000021929
Date of registration: 15/04/2016
Prospective Registration: Yes
Primary sponsor: Chiba University
Public title: Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
Scientific title: Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis - OPTIWIT Study
Date of first enrolment: 2016/06/01
Target sample size: 200
Recruitment status: Complete: follow-up continuing
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025148
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Kei    Ikeda
Address:  1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677 260-8677 Japan
Telephone: 043-222-7171
Email: K.Ikeda@faculty.chiba-u.jp
Affiliation:  Chiba University Hospital Department of Allergy and Clinical Immunology
Name: Kei    Ikeda
Address:  1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677 Japan
Telephone: 043-222-7171
Email: K.Ikeda@faculty.chiba-u.jp
Affiliation:  Chiba University Hospital Department of Allergy and Clinical Immunology
Key inclusion & exclusion criteria
Inclusion criteria:
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: 18years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)
Discontinuation of infliximab
Primary Outcome(s)
Difference in diagnostic value (AUC of ROC) to predict relapse between DAS28 and total PD score at baseline
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Mitsubishi Tanabe Pharma
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date: 20/01/2016
Contact:
prc-jim@chiba-u.jp
Chiba University Certified Clinical Research Review Board
043-222-7171
prc-jim@chiba-u.jp
Results
Results available:
Date Posted:
Date Completed: 14/08/2020
URL:
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