Trials / Completed
CompletedNCT02770794
Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis
Multicenter Prospective Trial to Investigate Accuracy of Ultrasound to Predict Relapse After Discontinuation of Infliximab and Efficacy/Safety of Readministration of Infliximab in Patients With Rheumatoid Arthritis in Low Disease Activity
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 211 (actual)
- Sponsor
- Chiba University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Infliximab | Discontinue infliximab; receive Infliximab when relapse |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2020-08-14
- Completion
- 2020-08-14
- First posted
- 2016-05-12
- Last updated
- 2021-01-20
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02770794. Inclusion in this directory is not an endorsement.