Proactive Infliximab Optimization Using a Pharmacokinetic Dashboard Versus Standard of Care in Patients With Inflammatory Bowel Disease: The OPTIMIZE Trial

NCT04835506 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2021P000391
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 25

Brief Summary

The OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in inflammatory bowel disease.

Conditions

Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• clinical remission

  Proportion of subjects with sustained corticosteroid-free (no CS use from Week 14 through 52) clinical remission (CD: CDAI \<150 at Weeks 14, 26, 52; UC: PRO2 ≤ 1 with an RBS = 0) and no disease worsening

  52 weeks

Secondary Outcomes (12)

• clinical remission

  52 weeks

• deep remission

  52 weeks

• composite biological and endoscopic remission

  52 weeks

• sustained CS-free clinical remission

  52 weeks

• primary non-responders

  14 weeks

Study Arms (2)

proactive infliximab optimization

EXPERIMENTAL

proactive infliximab optimization using a pharmacokinetic dashboard

Drug: Infliximab

standard of care infliximab dosing

EXPERIMENTAL

standard of care infliximab dosing

Drug: Infliximab

Interventions

Infliximab DRUG

infliximab

proactive infliximab optimization; standard of care infliximab dosing

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive.
• Moderately to severely active IBD, defined by a total CDAI score between 220 and 450 points for CD or a partial Mayo Score (PMS) \> 4 for UC (including a rectal bleeding subscore \[RBS\] ≥ 1), and at least 1 of the following:
• Elevated CRP (\> upper limit of normal)
• Elevated FC (\> 250 μg/g)
• SES-CD \> 6 (SES-CD \> 3 for isolated ileal disease) for CD only and a Mayo endoscopic subscore (MES) ≥ 2 for UC only.
• Physician intends to prescribe IFX as part of the usual care of the subject.
• No previous use of IFX prior to enrolment in the current study, unless the participant received 1 prior dose of IFX (within 2.5 weeks of enrolment) and met all eligibility criteria at the time of starting IFX and IFX was administered according to the requirements outlined in this protocol
• Able to participate fully in all aspects of this clinical trial.
• Written informed consent must be obtained and documented.

You may not qualify if:

• Participants with any of the following IBD-related complications:
• Abdominal or pelvic abscess, including perianal
• Presence of stoma, ileal pouch-anal anastomosis, or ostomy
• Isolated perianal disease
• Obstructive disease, such as obstructive stricture
• Short gut syndrome
• Toxic megacolon or any other complications that might require surgery, or any other manifestation that precludes or confounds the assessment of disease activity (CDAI or SES-CD for CD or PMS, PRO2, or MES for UC)
• Total colectomy.
• History or current diagnosis of ulcerative proctitis (UC extending \< 15 cm from the anal verge), acute severe (fulminant) UC, hospitalised IV steroid-refractory UC, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption.
• Current bacterial or parasitic pathogenic enteric infection, according to SOC assessments, including: Clostridioides difficile; tuberculosis; known infection with hepatitis B or C virus; known infection with HIV; sepsis; abscesses. History of the following: opportunistic infection within 6 months prior to screening; any infection requiring antimicrobial therapy within 2 weeks prior to screening; more than 1 episode of herpes zoster or any episode of disseminated zoster; any other infection requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening.
• Has any malignancy or lymphoproliferative disorder other than nonmelanoma cutaneous malignancies or cervical carcinoma in situ that has been treated with no evidence of recurrence within the last 5 years.
• Known primary or secondary immunodeficiency.
• PNR to adalimumab, defined as no objective evidence of clinical benefit after 14 weeks of therapy.
• Subjects with failure to a prior biologic, defined as PNR or SLR, will be excluded when a maximum of 40% of the planned enrollment (approximately 78 subjects) have failure to prior biologic exposure.
• Concomitant use of oral corticosteroid therapy exceeding prednisone 40 mg/day, budesonide 9 mg/day, or equivalent, unless a tapering schedule is initiated with a plan to be off CS by Week 14

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (25)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Rockford GI

Rockford, Illinois, 61107, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Atrium Health Center for Digestive Health

Charlotte, North Carolina, 28204, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

LifeSpan Brown University

Providence, Rhode Island, 02915, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 20500, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

London Health Sciences Centre - Children's Hospital

London, Canada

Location

McGill University Health Centre (MUHC) Montreal General Hospital

Montreal, Canada

Location

Related Publications (1)

• Papamichael K, Jairath V, Zou G, Cohen B, Ritter T, Sands B, Siegel C, Valentine J, Smith M, Vande Casteele N, Dubinsky M, Cheifetz A. Proactive infliximab optimisation using a pharmacokinetic dashboard versus standard of care in patients with Crohn's disease: study protocol for a randomised, controlled, multicentre, open-label study (the OPTIMIZE trial). BMJ Open. 2022 Apr 1;12(4):e057656. doi: 10.1136/bmjopen-2021-057656.

  PMID: 35365535 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: November 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: After completion and publication of primary study.
• Access Criteria: This data will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement

Locations

CA (2); US (23)