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 enrolled 614 people with ulcerative colitis — a condition causing inflammation of the large bowel. Most participants (476) were assigned to receive tofacitinib at a dose of 10 mg twice daily, 16 received tofacitinib at 15 mg twice daily, and 122 received a placebo (a dummy tablet with no active ingredient). The trial was measuring how many people reached "remission" — meaning their disease activity score dropped to a very low level — after 8 weeks of treatment. Note that because the 15 mg group was very small (only 16 people), the reported outcome figures focus on the 10 mg and placebo groups only. The reported data shows the following at the 8-week mark. For the primary goal — remission as measured by a standard disease activity scoring tool called the Mayo score — 18.5% of people in the tofacitinib 10 mg group met that definition, compared with 8.2% in the placebo group. For secondary measurements: when looking at healing of the bowel lining as seen on a camera examination, 31.3% of the tofacitinib 10 mg group met that threshold versus 15.6% on placebo. A broader measure called "clinical response" (a meaningful drop in the overall disease score) was recorded in 59.9% of the tofacitinib 10 mg group compared with 32.8% on placebo. More narrowly defined remission categories — based on bowel camera findings only, or on symptom scores alone — showed figures ranging from 6.7% down to 11.8% in the tofacitinib group versus 1.6% to 5.7% in the placebo group, depending on the exact definition used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 38425446) ↗
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.
Phase 3 Crohn's Disease and Colitis Trial, Completed
Who may 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 might be able to join this trial:
- You must be at least 18 years old
- You must have been officially diagnosed with ulcerative colitis (UC) at least 4 months before joining the study
- Your ulcerative colitis must currently be considered moderate to severe based on a standard scoring system used by doctors
- You must have already tried at least one of the following treatments without success, or been unable to tolerate it: steroid medications (taken by mouth or given through a drip), a medication called azathioprine or 6-mercaptopurine, or a type of medication called anti-TNF-alpha therapy
Who may not be able to join:
- You may not be eligible if you have a different type of colitis, such as indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or if your symptoms suggest you may have Crohn's disease instead
- You may not be eligible if your colitis only affects the last small section of your bowel (the bottom 15 cm)
- You may not be eligible if you have never received any treatment for your ulcerative colitis before
- You may not be eligible if your condition has reached a very severe or dangerous stage, such as fulminant colitis or toxic megacolon (confirm with trial site)
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.
Contact this trial
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Remission at Week 8
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.