NCT02770794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 11, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

4.4 years

First QC Date

May 11, 2016

Last Update Submit

January 15, 2021

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • 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

    48 week

Secondary Outcomes (6)

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

    48 week

  • Change in van der Heijde modified Sharp score

    48 week

  • Change in Health Assessment Questionnaire-Disability Index

    48 week

  • Change in EuroQoL 5 dimensions-5L

    48 week

  • EULAR response criteria based on DAS28 after readministration of infliximab

    12 week after relapse

  • +1 more secondary outcomes

Study Arms (1)

All patients

EXPERIMENTAL

Discontinue infliximab; Receive infliximab when relapse

Drug: Infliximab

Interventions

InfliximabDRUG

Discontinue infliximab; receive Infliximab when relapse

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chiba University Hospital

Chiba, 260-8677, Japan

Location

Related Publications (2)

  • 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.

    PMID: 24515410BACKGROUND

  • 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.

    PMID: 20360136BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Masking Details
Investigators were masked for ultrasound results
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

May 11, 2016

First Posted

May 12, 2016

Study Start

April 1, 2016

Primary Completion

August 14, 2020

Study Completion

August 14, 2020

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)