Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2021
• Main ID: NCT02770794
• Date of registration: 11/05/2016
• Prospective Registration: No
• Primary sponsor: Chiba University
• Public title: Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis OPTIWIT
• Scientific 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
• Date of first enrolment: April 1, 2016
• Target sample size: 211
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02770794
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Japan

Key inclusion & exclusion 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
-



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Infliximab

Primary Outcome(s)

Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse [Time Frame: 48 week]

Secondary Outcome(s)

EULAR response criteria based on DAS28 after readministration of infliximab [Time Frame: 12 week after relapse]

Area under the ROC curve for total gray-scale score to predict relapse [Time Frame: 48 week]

Change in EuroQoL 5 dimensions-5L [Time Frame: 48 week]

Change in van der Heijde modified Sharp score [Time Frame: 48 week]

Change in Health Assessment Questionnaire-Disability Index [Time Frame: 48 week]

Number of adverse events as assessed by CTCAE v4.0 [Time Frame: Through study completion, an average of 60 weeks]

Secondary ID(s)

137

Source(s) of Monetary Support

Please refer to primary and secondary sponsors