What side effects are associated with this type of intervention?

Infliximab, a TNF-α inhibitor used in the treatment of Ulcerative Colitis, can cause several side effects. Common adverse events include increased risk of infections (such as tuberculosis and other opportunistic infections), infusion reactions (fever, chills, pruritus, and rash), and potential development of antibodies against the drug, which can reduce its effectiveness. Other possible side effects are liver enzyme abnormalities, heart failure exacerbation, and a small increased risk of malignancies such as lymphoma. Patients should be monitored regularly to manage these risks effectively.

What prior FDA approvals exist?

The FDA has approved several anti-TNF-α agents for the treatment of Ulcerative Colitis, including infliximab (Remicade), adalimumab (Humira), and golimumab (Simponi). These biologics work by inhibiting tumor necrosis factor-alpha (TNF-α), a key inflammatory mediator in Ulcerative Colitis. Infliximab, in particular, has been a cornerstone in the management of moderate to severe cases. The concept of personalized dosing, such as the iDose dashboard-driven infliximab dosing, aims to optimize drug administration based on individual patient characteristics to improve efficacy and safety, although this approach is still under investigation.

What other types of research exist?

Promising novel alternatives to iDose dashboard-driven infliximab dosing for Ulcerative Colitis patients in 2024 include: 1) Ustekinumab, an interleukin-12 and interleukin-23 inhibitor, which can be used alone or in combination with immunomodulators. 2) Vedolizumab, an integrin inhibitor, which is effective for patients who have not responded to other biologics. 3) Proactive therapeutic drug monitoring to optimize dosing of existing biologics. These alternatives offer targeted mechanisms of action and personalized treatment approaches.

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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if using a computer program to decide infliximab doses is better and safer than standard dosing for patients with inflammatory bowel disease. The program helps doctors choose the best dose by looking at individual health details, aiming to keep the medication working well and prevent the disease from getting worse. Infliximab is commonly used to treat inflammatory bowel disease, and dose optimization has been shown to improve treatment outcomes.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 14, week 26, and week 52

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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%

Nausea

10%

Change in urination

10%

Heartburn

10%

Fatigue

10%

Dizziness

10%

Itchiness

Pain in joints

Chest pain

Stomach ache

Syncope

Menstruation

Migraine

Swelling

Bloody stool

Pain in leg

Allergies

Change in blood pressure

Vertigo

Change in appetite

Numbness

Motor vehicle accident

100%

80%

60%

40%

20%

Study treatment Arm

Infliximab

Placebo

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~3350

0 / 1Eligibility criteria met

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.