A Phase 4 interventional study of Infliximab in Arthritis, Rheumatoid, sponsored by Chiba University. Completed at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-20.
Sponsored by Chiba University · Phase 4, Interventional, and Treatment
This multicenter prospective clinical trial investigates the accuracy of ultrasound to predict relapse after discontinuation of infliximab and the efficacy/safety of readministration of infliximab in patients with rheumatoid arthritis in a low disease activity state.
The objective of this multicenter prospective clinical trial is to determine whether ultrasound 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. Infliximab is discontinued in all enrolled patients. Patients are followed up for 48 weeks for monitoring relapse. If relapse occurs, patients receive readministration of infliximab and are further followed up for 24 weeks to determine the efficacy and safety of infliximab readministration. Primary endpoint is the difference in area under curve (AUC) of receiver operator characteristics (ROC) analysis between total power Doppler score and Disease Activity Score (DAS) 28 at baseline to predict relapse within 48 weeks after discontinuation of infliximab.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 211 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Chiba University is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Discontinue infliximab; Receive infliximab when relapse
Drug: Infliximab
Discontinue infliximab; receive Infliximab when relapse
Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse
Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
Time frame: 48 week
Area under the ROC curve for total gray-scale score to predict relapse
Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
Time frame: 48 week
Change in van der Heijde modified Sharp score
Change in van der Heijde modified Sharp score at 48 week
Time frame: 48 week
Change in Health Assessment Questionnaire-Disability Index
Change in Health Assessment Questionnaire-Disability Index at 48 week
Time frame: 48 week
Change in EuroQoL 5 dimensions-5L
Change in EuroQoL 5 dimensions-5L at 48 week
Time frame: 48 week
EULAR response criteria based on DAS28 after readministration of infliximab
EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab
Time frame: 12 week after relapse
Number of adverse events as assessed by CTCAE v4.0
Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks
Time frame: Through study completion, an average of 60 weeks
Plan to share: No
Ran from Apr 2016 to primary completion in Aug 2020, 52 months.
Of 79 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's 52 months is close to that.
Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Infliximab
Chiba University