What the trial was testing
The trial enrolled 181 patients with crohn's disease. The study was sponsored by Celltrion and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was an early-stage trial — researchers are still confirming safety and getting an early look at how well the treatment works. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
The under-the-skin shot kept drug levels just as high as the IV infusion.
Gastroenterology · 2021 · NCT02883452
These findings — that the shot kept drug levels in the blood even higher than the IV — were published in the Gastroenterology and represent the headline result of the study.
Researchers tracked outcomes across 181 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with crohn's disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This study tested a more convenient way to get infliximab, a drug already FDA-approved for Crohn's and ulcerative colitis. If your doctor prescribes this treatment, you might be able to switch from clinic infusions to shots you give yourself at home. Ask your gastroenterologist if this option is right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open crohn's disease trials
Intermittent Caloric Restriction in Patients With Mild to Moderate Crohn's Disease
Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal (GI) tract. CD is a common inflammatory bowel disease (IBD), frequent (150,000 patients in France and 1.5 million in Europe), disabling and incurable. The environmental factors, and in particular diet, play a major role in the pathogenesis of CD. The prevalence of CD is steadily increasing in highly industrialized countries, where the Western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. On the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of CD, especially in pediatrics. There are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of IBD. To date, and despite patient concern, there is no consensus nutritional in the management of CD to influence the natural course of the disease. The investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with CD.
Phase 3 Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
The purpose of this study is to evaluate the efficacy of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease over 24 weeks.