Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2020-08-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiba University
• Treatments: Infliximab

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 -