Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

NCT ID: NCT02770794

Last Updated: 2021-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-01
• Study Completion Date: 2020-08-14

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All patients

Discontinue infliximab; Receive infliximab when relapse

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: DRUG

Discontinue infliximab; receive Infliximab when relapse

Interventions

Infliximab

Discontinue infliximab; receive Infliximab when relapse

Intervention Type: DRUG

Eligibility Criteria

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 -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiba University

OTHER

Sponsor Role: lead

Responsible Party

Kei Ikeda

Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Chiba University Hospital

Chiba, , Japan

Countries

Japan

References

Iwamoto T, Ikeda K, Hosokawa J, Yamagata M, Tanaka S, Norimoto A, Sanayama Y, Nakagomi D, Takahashi K, Hirose K, Sugiyama T, Sueishi M, Nakajima H. Prediction of relapse after discontinuation of biologic agents by ultrasonographic assessment in patients with rheumatoid arthritis in clinical remission: high predictive values of total gray-scale and power Doppler scores that represent residual synovial inflammation before discontinuation. Arthritis Care Res (Hoboken). 2014 Oct;66(10):1576-81. doi: 10.1002/acr.22303.

Reference Type: BACKGROUND

PMID: 24515410 (View on PubMed)

Tanaka Y, Takeuchi T, Mimori T, Saito K, Nawata M, Kameda H, Nojima T, Miyasaka N, Koike T; RRR study investigators. Discontinuation of infliximab after attaining low disease activity in patients with rheumatoid arthritis: RRR (remission induction by Remicade in RA) study. Ann Rheum Dis. 2010 Jul;69(7):1286-91. doi: 10.1136/ard.2009.121491. Epub 2010 Apr 1.

Reference Type: BACKGROUND

PMID: 20360136 (View on PubMed)

Other Identifiers

137

Identifier Type: -

Identifier Source: org_study_id