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Monoclonal Antibodies

Infliximab Optimization for Crohn's Disease

Phase 4
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Subjects with any of the following CD-related complications: Abdominal or pelvic abscess, including perianal, Presence of stoma 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), Total colectomy, History or current diagnosis of ulcerative colitis, 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, Presence of any medical condition or use of any medication that is a contraindication for IFX use, as outlined on the product label, A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study, Pregnant or lactating women, to be excluded based on the physician's usual practice for determining pregnancy or lactation status, Known intolerance or hypersensitivity to IFX or other murine proteins.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14, week 26, and week 52
Awards & highlights

Summary

This trial is testing whether a computer-driven system for dosing a medication is more effective and safer than standard dosing for Crohn's disease.

Who is the study for?
The OPTIMIZE Trial is for males and females aged 16-80 with moderately to severely active Crohn's Disease. Participants must have certain disease markers like elevated CRP or fecal calprotectin, and no prior significant use of Infliximab. Exclusions include those with specific CD complications, infections like tuberculosis or hepatitis B/C, recent serious infections, cancer within the last 5 years (except some skin cancers), immunodeficiency disorders, high-dose steroid use without tapering plans, pregnancy or lactation.Check my eligibility
What is being tested?
This trial tests if using an iDose dashboard-driven dosing method for Infliximab is more effective and safer than standard dosing in achieving and maintaining remission in Crohn's Disease patients. The study compares these two approaches to see which one better controls the symptoms of this digestive disorder.See study design
What are the potential side effects?
Infliximab can cause side effects such as risk of infection due to weakened immune response, allergic reactions including rash and difficulty breathing during infusion, headaches, stomach pain, nausea. It may also increase the risk of developing certain types of cancers.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have complications or conditions that would interfere with the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14, week 26, and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14, week 26, and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
biological remission
clinical remission
composite biological and endoscopic remission
+9 more

Side effects data

From 2020 Phase 4 trial • 42 Patients • NCT03006393
52%
Laceration
38%
Headache
24%
Bruises
19%
Sore throat
14%
Muscle tension
10%
Fatigue
10%
Change in urination
10%
Heartburn
10%
Nausea
10%
Dizziness
10%
Itchiness
5%
Migraine
5%
Menstruation
5%
Pain in joints
5%
Syncope
5%
Chest pain
5%
Stomach ache
5%
Swelling
5%
Bloody stool
5%
Pain in leg
5%
Allergies
5%
Change in blood pressure
5%
Vertigo
5%
Change in appetite
5%
Numbness
5%
Motor vehicle accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Infliximab
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: standard of care infliximab dosingExperimental Treatment1 Intervention
standard of care infliximab dosing
Group II: proactive infliximab optimizationExperimental Treatment1 Intervention
proactive infliximab optimization using a pharmacokinetic dashboard
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Infliximab
2017
Completed Phase 4
~3280

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Anti-TNF agents like infliximab are commonly used treatments for Ulcerative Colitis (UC) that work by inhibiting tumor necrosis factor-alpha (TNF-α), a cytokine involved in inflammation. By blocking TNF-α, these medications reduce inflammation, alleviate symptoms, and promote mucosal healing, which is essential for achieving and maintaining remission in UC patients. Personalized dosing strategies, such as those using the iDose dashboard, aim to optimize infliximab administration, ensuring effective treatment with minimal side effects, thereby improving patient outcomes and quality of life.
Repeated intensified infliximab induction - results from an 11-year prospective study of ulcerative colitis using a novel treatment algorithm.

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
840 Previous Clinical Trials
13,011,523 Total Patients Enrolled
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
58 Previous Clinical Trials
93,844 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
871 Previous Clinical Trials
527,076 Total Patients Enrolled

Media Library

Infliximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04835506 — Phase 4
Inflammatory Bowel Disease Research Study Groups: standard of care infliximab dosing, proactive infliximab optimization
Inflammatory Bowel Disease Clinical Trial 2023: Infliximab Highlights & Side Effects. Trial Name: NCT04835506 — Phase 4
Infliximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835506 — Phase 4
~26 spots leftby Dec 2024