Crohn's Disease and Colitis Trial, Completed NCT02539368 Sponsor: Pfizer Condition: Crohn's Disease and Colitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial (NCT02539368) followed 2,543 people in total across five groups. The groups were: people who received CT-P13 (1,522 participants), people who received Remicade (494 participants), people who switched from Remicade to CT-P13 (358 participants), people who switched from CT-P13 to Remicade (67 participants), and people who switched between the two treatments more than once (102 participants). All participants had been diagnosed with inflammatory bowel disease — either Crohn's disease or ulcerative colitis. The trial was an observational study, meaning it tracked real-world treatment patterns rather than randomly assigning treatments. It recorded things like how long people had lived with their disease, how often they switched between the two medicines, why they switched, and how their doses changed over time. The reported data shows that participants in the CT-P13-only group had been living with their disease for a median (middle value) of 63 months at the time they joined the study, compared to 112.5 months for those in the Remicade-only group and 120 months for those who switched from Remicade to CT-P13. Regarding switching: 237 people with Crohn's disease and 121 people with ulcerative colitis switched from Remicade to CT-P13; 47 people with Crohn's disease and 20 with ulcerative colitis switched from CT-P13 to Remicade; and 72 people with Crohn's disease and 30 with ulcerative colitis switched more than once. The reported data shows that dose changes (either an increase or a reduction) occurred in 479 participants in the CT-P13 group, 110 in the Remicade group, 89 in the Remicade-to-CT-P13 switchers group, 28 in the CT-P13-to-Remicade switchers group, and 31 in the multiple switchers group. The total dose amounts were listed as "not available" in the submitted data, so those figures were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Crohn's Disease and Colitis Trial, Completed

NCT02539368
Completed Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • You were at least 12 years old when you were first diagnosed with Crohn's disease (CD) or ulcerative colitis (UC), and you are at least 18 years old at the time of joining the study.
  • Your doctor has prescribed you either CT-P13 (a biosimilar infliximab) or Remicade (infliximab) to treat your Crohn's disease or ulcerative colitis, following standard prescribing guidelines.
  • You may still be eligible if you have had a stoma, bowel surgery, or a pouch procedure.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • You have any medical reasons why you should not take CT-P13 or Remicade, based on the official prescribing guidelines (confirm with trial site).
  • You have a known allergy or serious reaction to infliximab, any of its ingredients, or similar proteins derived from mice — including any severe reactions during a previous infusion.
  • You have previously tried Remicade or CT-P13 and it did not work for you.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
22 April 2015
Est. completion
31 October 2018

Where this trial was run

🇧🇪 Belgium 🇨🇿 Czechia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇹 Italy 🇳🇱 Netherlands 🇵🇹 Portugal 🇸🇰 Slovakia 🇪🇸 Spain 🇬🇧 United Kingdom

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Disease Characteristics of Participants: Disease Duration; Number of Participants Who Switched Treatment; Reasons for Switching Treatment by Participants; Total Dose of Infusion Received; Number of Participants by Frequency of Infusion Received; Number of Participants Who Had Change in Infusion Dose; Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change; Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC); Number of Participants With Treatment-Emergent Adverse Event (AEs), Se...

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov