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 long-term trial (NCT01470612) looked at tofacitinib in two dose groups: 175 people took the lower dose (5 mg twice daily) and 769 people took the higher dose (10 mg twice daily), giving a total of 944 participants. The trial was primarily measuring safety-related outcomes — that is, it was tracking unwanted medical events, serious infections, abnormal blood test results, changes in vital signs (like blood pressure and heart rate), physical examination changes, and heart tracing (ECG) abnormalities that occurred while people were taking the study drug. The follow-up period was lengthy, running up to about 81–85 months (roughly 7 years) depending on the dose group. The reported data shows that, among those in the lower-dose group, 154 out of 175 participants experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened after starting the study drug), while 626 out of 769 did so in the higher-dose group. Serious adverse events were recorded for 39 people in the lower-dose group and 147 in the higher-dose group. Serious infections — those needing hospital treatment or intravenous antibiotics — were reported in 8 people (lower dose) and 31 people (higher dose). Laboratory test abnormalities were recorded for 162 participants in the lower-dose group and 670 in the higher-dose group. Clinically significant physical examination changes were noted in 84 and 391 participants respectively. Various vital sign abnormalities (such as notable swings in blood pressure or pulse rate) were also recorded across both groups at different thresholds. The reported data shows that no participants in either group met the pre-defined thresholds for abnormal ECG readings across the three measures tracked. It is worth noting that a much higher proportion of participants did not complete the trial — 84 in the lower-dose group and 665 in the higher-dose group — though the reasons for not completing were not detailed in the data provided here. 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 38778549) ↗
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 previously took part in a related study (called A3921094 or A3921095) and your condition did not improve enough to meet the required response levels by the end of that study.
- You previously took part in another related study (called A3921096) and either completed it fully, or had to stop early because the treatment was not working well enough for you.
Who may not be able to join:
- You seriously broke the rules or procedures of one of the previous related studies (A3921094, A3921095, or A3921096) (confirm with trial site).
- You have been diagnosed with, or show signs of, a type of bowel or colon condition other than ulcerative colitis — such as Crohn's disease, microscopic colitis, ischemic colitis, or an infection-related colitis.
- You have already had surgery for ulcerative colitis, or the doctors believe you are likely to need surgery for it during the time you would be in this trial.
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
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs); Number of Participants With Serious Infections as Treatment Emergent Adverse Events (TEAEs); Number of Participants With Laboratory Test Abnormalities; Number of Participants With Vital Sign Abnormalities; Number of Participants With Clinically Significant Changes in Physical Examinations From Baseline; Number of Participants With Electrocardiogram (ECG) Abnormalities; Incidence Rates for Adjudicated Cardiovascular, Malignancy, Opportunistic Infections and Thromboembolic Safety Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.