Table of Contents
- Overview of Infliximab trials
- Digestive disease studies
- Immune and rheumatic disease studies
- Cancer-related studies
- Study designs, phases, and populations
- Main endpoints used in the trials
Overview of Infliximab trials
Across the trial list, Infliximab is being studied in many different settings, not as a general drug summary but as part of specific clinical research projects.[1] Most trials are in Phase 2 or Phase 3, and they look at whether treatment helps patients reach remission, avoid relapse, or improve disease control.[1] Some studies also compare Infliximab with another biologic medicine, with standard care, or with treatment changes such as dose escalation or switching from intravenous to subcutaneous use.[1]
Digestive disease studies
Many of the Infliximab trials focus on ulcerative colitis and Crohn’s disease, which are long-term inflammatory bowel diseases.[1] Some studies include people with active disease, while others include patients in remission or patients after bowel surgery who are at risk of recurrence.[1]
The COMBO-UC trial compares Infliximab with ustekinumab and a dual-biologic strategy in people with moderately to severely active ulcerative colitis, and its main endpoint is clinical and endoscopic remission after induction treatment.[1] The RESPECT trial studies ulcerative colitis that did not respond to induction treatment and measures sustained steroid-free remission at week 52.[1] The FLAMING study in Crohn’s disease also looks at sustained steroid-free remission, comparing monotherapy with combination therapy after vedolizumab failure.[1]
Other bowel studies look at treatment strategy rather than only one drug. The AMARETTO trial studies switching to subcutaneous Infliximab after a stable intravenous schedule, and it measures whether patients keep steroid-free clinical and biological remission by week 52 without treatment optimization.[1] The Pro-RAPID and PASSPORT studies focus on drug exposure and drug levels, which means they measure how much medicine is present in the blood during treatment.[1] The IGNITE study looks at model-informed precision dosing, a way of using calculations to help choose the right dose more accurately in steroid-refractory acute severe ulcerative colitis.[1]
Postoperative Crohn’s disease is another major area. The POMEROL trial studies patients who already have postoperative endoscopic recurrence and tests whether treatment escalation can improve endoscopic healing at 12 months.[1] The study on prevention of postoperative recurrence compares starting biologic therapy right after ileocolonic resection with starting treatment only after recurrence is seen on endoscopy.[1]
Immune and rheumatic disease studies
Infliximab is also being studied in immune system and rheumatic diseases, where the goal is often to lower inflammation and keep disease quiet.[1] In Takayasu arteritis, the STARS and INTOReTAK studies measure disease remission or inactive disease while also tracking prednisone stopping or reduction.[1] Takayasu arteritis is a rare disease that affects large blood vessels, and the trial uses disease activity scores and imaging findings to judge response.[1]
In rheumatoid arthritis and psoriatic arthritis, the trials compare different treatment approaches and ask whether patients can keep low disease activity while reducing systemic immunosuppressive therapy.[1] The rheumatoid arthritis studies use outcomes such as ACR20, which means at least a 20% improvement by American College of Rheumatology rules, and disease activity scores over time.[1] The psoriatic arthritis study measures minimal disease activity after tapering treatment, which means lowering medicine while trying to avoid symptom return.[1]
Cancer-related studies
Several trials include Infliximab as a supportive or safety-related medicine in cancer studies, especially where immune-related side effects are being managed.[1] For example, the iCaD study compares an anti-inflammatory regimen with corticosteroid alone for severe immune checkpoint inhibitor related colitis or diarrhea.[1] In this setting, Infliximab is part of the treatment strategy being tested to control bowel inflammation caused by cancer immunotherapy.[1]
Other oncology trials list Infliximab alongside medicines such as durvalumab, tremelimumab, rilvegostomig, or trastuzumab deruxtecan, but the main study question is usually about the cancer treatment combination rather than Infliximab itself.[1] These trials often measure overall survival, progression-free survival, disease-free survival, event-free survival, or objective response rate.[1] In some studies, Infliximab appears in the protocol as a rescue or safety medication rather than the main experimental treatment.[1]
Study designs, phases, and populations
The trial list includes interventional studies, meaning the researchers assign a treatment or treatment plan to the participants.[1] Most are randomized studies, where people are assigned by chance to different groups, and several are also blinded, which means patients and/or researchers may not know which treatment is given.[1] Enrollment ranges from very small proof-of-concept studies, such as 13 patients in the IGNITE study, to large Phase 3 trials with more than 1,000 participants.[1]
Target populations vary widely. Some trials include adults with advanced cancer, some include children with ulcerative colitis, and others focus on patients after surgery, after failure of prior therapy, or after remission has already been reached.[1] This shows that Infliximab is being tested in both active disease and maintenance settings, depending on the trial question.[1]
Main endpoints used in the trials
The main endpoint, or main result, is different in each study, but several patterns appear again and again.[1] In bowel disease trials, common endpoints include clinical remission, steroid-free remission, endoscopic recurrence, and endoscopic response.[1] Endoscopic means seen with a camera test inside the bowel, and steroid-free means the result is achieved without needing corticosteroids.[1]
In cancer-related studies, the main endpoints often include overall survival, progression-free survival, disease-free survival, event-free survival, or objective response rate.[1] In some studies, safety outcomes are also important, such as adverse events, serious adverse events, infusion-related reactions, or dose-limiting toxicities, which means side effects serious enough to limit how much treatment can be given.[1] Other trials measure blood drug levels, imaging findings, laboratory tests, or disease activity scores to understand how treatment is working in the body.[1]
