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Smart dosing for IBD: Computer-Guided drug delivery shows promise

NCT ID NCT04835506

Disease control Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a computer dashboard to guide infliximab dosing is more effective and safer than standard dosing for people with Crohn's disease or ulcerative colitis. About 124 participants will receive either dashboard-guided or standard treatment, with the goal of achieving and maintaining remission without steroids. The approach aims to better control disease and reduce side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 124 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Males or nonpregnant, nonlactating females aged 16 to 80 years inclusive. 2. Diagnosis of IBD prior to screening using standard endoscopic, histologic, or radiologic criteria. Participants with patchy colonic inflammation initially diagnosed as indeterminate colitis would meet inclusion criteria, if the investigator feels that the findings are consistent with CD or UC. Enrollment of participants with UC will be capped at 49% of the planned study population (maximum 61 participants). 3. 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: 1. Elevated CRP (\> upper limit of normal) 2. Elevated FC (\> 250 μg/g) 3. SES-CD \> 6 (SES-CD \> 3 for isolated ileal disease) for CD only and a Mayo endoscopic subscore (MES) ≥ 2 for UC only. 4. Physician intends to prescribe IFX as part of the usual care of the subject. 5. 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 6. Able to participate fully in all aspects of this clinical trial. 7. Written informed consent must be obtained and documented. Exclusion Criteria: 1. Participants with any of the following IBD-related complications: 1. Abdominal or pelvic abscess, including perianal 2. Presence of stoma, ileal pouch-anal anastomosis, or ostomy 3. Isolated perianal disease 4. Obstructive disease, such as obstructive stricture 5. Short gut syndrome 6. 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) 7. Total colectomy. 2. 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. 3. 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. 4. 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. 5. Known primary or secondary immunodeficiency. 6. PNR to adalimumab, defined as no objective evidence of clinical benefit after 14 weeks of therapy. 7. 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. 8. 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 9. Presence of any medical condition or use of any medication that is a contraindication for IFX use, as outlined on the product label. 10. 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. 11. Pregnant or lactating women, to be excluded based on the physician's usual practice for determining pregnancy or lactation status. 12. Known intolerance or hypersensitivity to IFX or other murine proteins.

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Inflammatory bowel diseases Ulcerative colitis

Contacts and locations

Locations

  • Atrium Health Center for Digestive Health

    Charlotte, North Carolina, 28204, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • LifeSpan Brown University

    Providence, Rhode Island, 02915, United States

  • London Health Sciences Centre - Children's Hospital

    London, Canada

  • McGill University Health Centre (MUHC) Montreal General Hospital

    Montreal, Canada

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

  • Rockford GI

    Rockford, Illinois, 61107, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60637, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 20500, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • Yale University School of Medicine

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.