Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Infliximab

• Registration Number: NCT02770794
• Lead Sponsor: Chiba University

Brief 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.

Study Timeline

• Study Start: 2016-04-01
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2020-08-14
• Study Completion: 2020-08-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Infliximab	Discontinue infliximab; Receive infliximab when relapse

Primary Outcome Measures

Name	Time	Method
Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse	48 week	Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab

Secondary Outcome Measures

Name	Time	Method
Change in Health Assessment Questionnaire-Disability Index	48 week	Change in Health Assessment Questionnaire-Disability Index at 48 week
EULAR response criteria based on DAS28 after readministration of infliximab	12 week after relapse	EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab
Area under the ROC curve for total gray-scale score to predict relapse	48 week	Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab
Number of adverse events as assessed by CTCAE v4.0	Through study completion, an average of 60 weeks	Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks
Change in van der Heijde modified Sharp score	48 week	Change in van der Heijde modified Sharp score at 48 week
Change in EuroQoL 5 dimensions-5L	48 week	Change in EuroQoL 5 dimensions-5L at 48 week

Trial Locations

Locations (1)

Chiba University Hospital; 🇯🇵 Chiba, Japan