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Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis (OPTIWIT)

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Infliximab

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years or older
RA patients who fulfill 2010 ACR/EULAR Classification Criteria
Patients who have been treated with infliximab (Remicade) for 26 weeks or longer
DAS28 (CRP) < 3.2 at screening
Patients who give written informed consent after receiving sufficient information -

Exclusion Criteria:

Receiving prednisolone > 10 mg/day
Receiving biological or molecular-target anti-rheumatic drug
Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit
Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit
History of infusion reaction to infliximab
Current infection which requires treatment
Current or previous demyelinating disorder
Current congestive heart failure which requires treatment
Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period
Patients whom investigator or co-investigator consider inappropriate for other reasons -

Sites / Locations

Chiba University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

Discontinue infliximab; Receive infliximab when relapse

Outcomes

Primary Outcome Measures

Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse

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

Area under the ROC curve for total gray-scale score to predict relapse

Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab

Change in van der Heijde modified Sharp score

Change in van der Heijde modified Sharp score at 48 week

Change in Health Assessment Questionnaire-Disability Index

Change in Health Assessment Questionnaire-Disability Index at 48 week

Change in EuroQoL 5 dimensions-5L

Change in EuroQoL 5 dimensions-5L at 48 week

EULAR response criteria based on DAS28 after readministration of infliximab

EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab

Number of adverse events as assessed by CTCAE v4.0

Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks

Full Information

NCT ID

NCT02770794

First Posted

May 11, 2016

Last Updated

January 15, 2021

Sponsor

Chiba University

1. Study Identification

Unique Protocol Identification Number

NCT02770794

Brief Title

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

Acronym

OPTIWIT

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2016 (Actual)

Primary Completion Date

August 14, 2020 (Actual)

Study Completion Date

August 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chiba University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Investigators were masked for ultrasound results

Allocation

N/A

Enrollment

211 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All patients

Arm Type

Experimental

Arm Description

Discontinue infliximab; Receive infliximab when relapse

Intervention Type

Drug

Intervention Name(s)

Infliximab

Intervention Description

Discontinue infliximab; receive Infliximab when relapse

Primary Outcome Measure Information:

Title

Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse

Description

Area under the ROC curve for total power Doppler score at baseline to predict relapse within 48 weeks after discontinuation of infliximab

Time Frame

48 week

Secondary Outcome Measure Information:

Title

Area under the ROC curve for total gray-scale score to predict relapse

Description

Area under the ROC curve for total gray-scale score at baseline to predict relapse within 48 weeks after discontinuation of infliximab

Time Frame

48 week

Title

Change in van der Heijde modified Sharp score

Description

Change in van der Heijde modified Sharp score at 48 week

Time Frame

48 week

Title

Change in Health Assessment Questionnaire-Disability Index

Description

Change in Health Assessment Questionnaire-Disability Index at 48 week

Time Frame

48 week

Title

Change in EuroQoL 5 dimensions-5L

Description

Change in EuroQoL 5 dimensions-5L at 48 week

Time Frame

48 week

Title

EULAR response criteria based on DAS28 after readministration of infliximab

Description

EULAR response criteria based on DAS28 at 12 week after relapse and readministration of infliximab

Time Frame

12 week after relapse

Title

Number of adverse events as assessed by CTCAE v4.0

Description

Number of adverse events as assessed by CTCAE v4.0 through study completion, an average of 60 weeks

Time Frame

Through study completion, an average of 60 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years or older RA patients who fulfill 2010 ACR/EULAR Classification Criteria Patients who have been treated with infliximab (Remicade) for 26 weeks or longer DAS28 (CRP) < 3.2 at screening Patients who give written informed consent after receiving sufficient information - Exclusion Criteria: Receiving prednisolone > 10 mg/day Receiving biological or molecular-target anti-rheumatic drug Alteration of the dose of corticosteroid or anti-rheumatic drug within 8 weeks prior to screening visit Alteration of the dose of non-steroid anti-inflammatory drug within 4 weeks prior to screening visit History of infusion reaction to infliximab Current infection which requires treatment Current or previous demyelinating disorder Current congestive heart failure which requires treatment Breast-feeding or pregnant/possibly pregnant woman, or woman who does not agree to prevent conception during and 6 months after study period Patients whom investigator or co-investigator consider inappropriate for other reasons -

Facility Information:

Facility Name

Chiba University Hospital

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24515410

Citation

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.

Results Reference

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PubMed Identifier

20360136

Citation

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.

Results Reference

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Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

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