Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis (OPTIWIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02770794
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Kei Ikeda, Chiba University

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 1, 2016
Actual Primary Completion Date : August 14, 2020
Actual Study Completion Date : August 14, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

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




Primary Outcome Measures :
  1. Area under the Receiver Operator Characteristic (ROC) curve for total power Doppler score to predict relapse [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 week ]
    Change in van der Heijde modified Sharp score at 48 week

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

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

  5. EULAR response criteria based on DAS28 after readministration of infliximab [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770794


Locations
Layout table for location information
Japan
Chiba University Hospital
Chiba, Japan, 260-8677
Sponsors and Collaborators
Chiba University
Publications:
Layout table for additonal information
Responsible Party: Kei Ikeda, Senior Lecturer, Chiba University
ClinicalTrials.gov Identifier: NCT02770794    
Other Study ID Numbers: 137
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents