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IBD drug costs may depend on your weight, study finds

NCT ID NCT07495800

Knowledge-focused Sponsor: Assiut University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how weight and body mass index (BMI) change in people with inflammatory bowel disease (IBD) who are treated with biologic drugs. Researchers will track weight monthly and see if higher BMI leads to higher drug doses and costs. The goal is to understand the financial impact of these treatments based on body size.

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.

Participants

About 50 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2027

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.

Who is studied

* Patients underwent clinical, laboratory, endoscopic, and/or imaging evaluations as part of routine outpatient monitoring. Current medications and Serum IFX concentrations will offered for collection. * Laboratory investigations (Complete blood picture, Liver function tests, C-reactive protein and ESR, Fecal calprotectin). * The following variables were evaluated: age, sex, BMI \[weight (kg)/height (m)²\], smoking history, history of IBD-related surgeries, current and prior concomitant medications, disease duration, Montreal classification, and clinical activity indices for CD and UC. Clinical activity of CD was assessed using the Harvey-Bradshaw Index (HBI), with clinical remission defined as an HBI score ≤ 4 points. * Clinical activity of UC was assessed using the partial Mayo score, with clinical remission defined as a score ≤ 2 points

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients must have received infliximab (IFX) therapy for at least 14 weeks and completed the on-label induction regimen (5 mg/kg IV at weeks 0, 2, and 6), regardless of the dose at the time of blood collection (patients receiving optimized doses are eligible). * Patients may be on IFX monotherapy or in combination with one of the following medications at the time of selection: aminosalicylates, antibiotics, prednisone, azathioprine, 6-mercaptopurine, or methotrexate. Exclusion Criteria: * Patients receiving IFX in combination with tacrolimus, cyclosporine, sirolimus, mycophenolate mofetil, another immunobiological agent, or tofacitinib. * Patients with insufficient data in their electronic medical records.

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease

As listed by the trial registrant

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

Inflammatory bowel diseases weight changes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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