Unique ID issued by UMIN | UMIN000021929 |
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Receipt number | R000025148 |
Scientific Title | Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis |
Date of disclosure of the study information | 2016/04/15 |
Last modified on | 2020/08/19 13:53:43 |
Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
OPTIWIT Study
Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
OPTIWIT Study
Japan |
Rheumatoid arthritis
Clinical immunology |
Others
NO
To determine whether ultrasonography predicts relapse after discontinuation of infliximab more accurately than does clinical index and to investigate the efficacy and safety of restarting infliximab after relapse in patients with rheumatoid arthritis in remission or low disease activity on infliximab treatment
Safety,Efficacy
Difference in diagnostic value (AUC of ROC) to predict relapse between DAS28 and total PD score at baseline
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Medicine |
Discontinuation of infliximab
18 | years-old | <= |
Not applicable |
Male and Female
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
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
200
1st name | Kei |
Middle name | |
Last name | Ikeda |
Chiba University Hospital
Department of Allergy and Clinical Immunology
260-8677
1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677
043-222-7171
K.Ikeda@faculty.chiba-u.jp
1st name | Kei |
Middle name | |
Last name | Ikeda |
Chiba University Hospital
Department of Allergy and Clinical Immunology
260-8677
1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677
043-222-7171
K.Ikeda@faculty.chiba-u.jp
Chiba University
Mitsubishi Tanabe Pharma
Profit organization
Chiba University Certified Clinical Research Review Board
1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260-8677
043-222-7171
prc-jim@chiba-u.jp
NO
2016 | Year | 04 | Month | 15 | Day |
Unpublished
No longer recruiting
2015 | Year | 12 | Month | 17 | Day |
2016 | Year | 01 | Month | 20 | Day |
2016 | Year | 06 | Month | 01 | Day |
2020 | Year | 08 | Month | 14 | Day |
2016 | Year | 04 | Month | 15 | Day |
2020 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025148
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