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NCT Number: NCT02770794

Optimization of Infliximab Withdrawal Strategy for Rheumatoid Arthritis

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chiba University Hospital

Chiba, 260-8677, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Infliximab

Drug

Discontinue infliximab; receive Infliximab when relapse

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiba University

Other

Registry information

Official study 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

Acronym: OPTIWIT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
May 12, 2016
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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