NCT02453776

Brief Summary

Infliximab (IFX) is highly effective in inducing and maintaining remission in patients with inflammatory bowel disease (IBD). However, a large proportion of patients will eventually lose response to IFX. Therefore, strategies to improve the outcome of maintenance treatment with IFX are required. Retrospective analyses suggest that adjusting IFX treatment in order to achieve IFX trough levels (TL) above a well-defined therapeutic threshold will improve the outcome of IFX treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2015

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

First Submitted

Initial submission to the registry

April 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

3.6 years

First QC Date

April 28, 2015

Last Update Submit

August 2, 2019

Conditions

Inflammatory Bowel Disease

Keywords

Crohns DiseaseUlcerative ColitisInfliximabSustainedRemissionInflammatory bowel diseaseIBD

Outcome Measures

Primary Outcomes (1)

  • Sustained clinical remission for the precision dosing group vs. the conventional IFX maintenance dosing group

    Sustained clinical remission based on HBI (Crohn's disease) or PM score (Ulcerative Colitis)

    52 weeks

Secondary Outcomes (4)

  • Cost of IFX treatment between the two groups

    52 weeks

  • Proportion of patients with antibodies against IFX

    52 weeks

  • Quality of life

    52 weeks

  • Biochemical disease activity (CRP >5mg/L and fecal calprotectin ≥50% compared to baseline, to a value of >250 ug/g)

    26 weeks, 52 weeks

Study Arms (2)

PRECISION dosing

EXPERIMENTAL

Infliximab may vary between 1-10 mg/kg and the interval between 4 and 12 weeks.

Drug: PRECISION dosing Infliximab

Conventional dosing of Infliximab

NO INTERVENTION

Infliximab 5 mg/kg every 8 or 6 weeks

Interventions

PRECISION dosing InfliximabDRUG

Patients in the PRECISION dosing arm will recieve model based dosing, whereas proactive adjustments in treatment can be made by measuring the Infliximab concentration.

PRECISION dosing

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of CD or UC based on endoscopy and pathology
  • years or older
  • Clinical remission, based on a Harvey Bradshaw Index (HBI) score ≤4 or a Partial Mayo (PM) score ≤2, for CD and UC
  • Scheduled IFX maintenance treatment, regardless of interval/dosing

You may not qualify if:

  • \- Dilatation or resectional surgery because of stenotic IBD in the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1102 AZ, Netherlands

Location

Related Publications (1)

  • Strik AS, Lowenberg M, Mould DR, Berends SE, Ponsioen CI, van den Brande JMH, Jansen JM, Hoekman DR, Brandse JF, Duijvestein M, Gecse KB, de Vries A, Mathot RA, D'Haens GR. Efficacy of dashboard driven dosing of infliximab in inflammatory bowel disease patients; a randomized controlled trial. Scand J Gastroenterol. 2021 Feb;56(2):145-154. doi: 10.1080/00365521.2020.1856405. Epub 2020 Dec 8.

    PMID: 33290108DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • G D'Haens

    Professor gastroenterology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

NL(1)