Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with prior biologic therapy (biologic-experienced);

Patients with incomplete outcome or therapy data;

Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases;

Pregnant patients;

Trial population

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

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab

    Biological/Vaccine

    Efficacy of different biological treatment on patient with inflammatory bowel disease

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

The primary endpoints of this study are the percentages of hospitalization, surgery, corticosteroid-free remission, and endoscopic remission in patients with inflammatory bowel disease receiving biological therapies at week 52. Patients will be considered on corticosteroids if they received a course of prednisolone, budesonide, or any other steroid medication more than six weeks after initiating the current biological therapy, excluding the induction corticosteroid course, and those who did not receive any steroid courses after this period will be considered in corticosteroid-free remission. Endoscopic remission is defined as the number of patients achieving endoscopic remission, with an Endoscopic Mayo score of 0-1 for ulcerative colitis and a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 0-2 for .Surgical outcomes include patients who underwent IBD-related surgeries six weeks or more after starting the current biologic for an IBD-related issue or complications

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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