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Biologic showdown: which IBD drug works best after a year?

NCT ID NCT07495644

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will follow 95 adults with moderate-to-severe Crohn's disease or ulcerative colitis in Upper Egypt who are taking one of five biologic drugs: adalimumab, infliximab, ustekinumab, golimumab, or vedolizumab. After one year, researchers will measure how many patients avoid hospitalization, surgery, and steroids, and achieve endoscopic remission. The goal is to compare the effectiveness of these treatments in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab (biologic drugs)
What this could lead to
If successful, this could show which biologic works best for controlling IBD over a year, helping doctors choose more effective treatments.
What could go wrong
This is a small, early-stage study (95 people) in one region, so results may not apply broadly. Biologics also carry risks like serious infections.

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 95 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

This study is a retrospective, observational study involving chart reviews of patients with inflammatory bowel disease (IBD) at Luxor International Hospital.

Ages

18 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.

1. Inclusion Criteria: 1) Age ≥ 18 years; 2) Patients with moderate-to-severe ulcerative colitis, defined as a clinical Mayo score \>6 with an endoscopic score of 2-3 3) Patients with moderate-to-severe Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) \>220 with a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥7 4) Patients receiving adalimumab, infliximab, ustekinumab, or vedolizumab; 5) Patients who had been on the current biologic therapy for between 6 weeks and 12 months; and 6) Biologic-naïve patients (no prior biologic therapy). Patients who did not continue their treatment for 12 months due to primary or secondary treatment failure will be considered not to have achieved endoscopic remission. Additionally, patients who were hospitalized, received corticosteroids, or underwent surgery due to medication failure before 12 months of therapy will be considered treatment failures. 2. Exclusion Criteria: 1. Patients with prior biologic therapy (biologic-experienced); 2. Patients with incomplete outcome or therapy data; 3. Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases; 4. Pregnant patients; 5. Patients with intermittent suspension of therapy during the 12-month period.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

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

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