OPTIWIT: Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

• Sponsor: Chiba University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02770794
• Collaborator: (none)
• Enrollment: 211
• Location: 1
• Arm: 1
• Actual Duration (Months): 52.4
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Drug: Infliximab	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 211 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Investigators were masked for ultrasound results
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Aug 14, 2020
• Actual Study Completion Date: Aug 14, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All patients Discontinue infliximab; Receive infliximab when relapse	Drug: Infliximab; Discontinue infliximab; receive Infliximab when relapse

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Change in van der Heijde modified Sharp score [48 week]

   Change in van der Heijde modified Sharp score at 48 week

3. Change in Health Assessment Questionnaire-Disability Index [48 week]

   Change in Health Assessment Questionnaire-Disability Index at 48 week

4. Change in EuroQoL 5 dimensions-5L [48 week]

   Change in EuroQoL 5 dimensions-5L at 48 week

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chiba University Hospital	Chiba		Japan	260-8677

Sponsors and Collaborators

• Chiba University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Kei Ikeda, Senior Lecturer, Chiba University
• ClinicalTrials.gov Identifier: NCT02770794
• Other Study ID Numbers: 137
• First Posted: May 12, 2016
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Infliximab

Study Results

No Results Posted as of Jan 20, 2021