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 (NCT01393626) enrolled 279 people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were divided into four groups: 91 received a placebo (a dummy treatment with no active ingredient), 86 received tofacitinib at 5 mg twice daily, 86 received tofacitinib at 10 mg twice daily, and 16 received tofacitinib at 15 mg twice daily. The trial ran for 8 weeks and used a scoring system called the CDAI (Crohn's Disease Activity Index), which combines eight different measures of disease — such as bowel habits, pain, and general wellbeing — into a single number ranging from 0 to around 600, where a higher number means more severe disease. The main thing being measured was how many people in each group reached a CDAI score below 150 by week 8, which was defined in this trial as being in "remission" (very low disease activity). The 15 mg group was closed early due to low numbers, so formal results for that group were only reported for the CDAI score measure. The reported data shows that at week 8, approximately 36.7% of placebo participants, 43.5% of the 5 mg tofacitinib group, and 43.0% of the 10 mg tofacitinib group had a CDAI score below 150. For secondary measures, the trial also tracked how many people had a meaningful drop in their CDAI score — either a fall of at least 70 points or at least 100 points from where they started. By week 8, a drop of at least 70 points was reported in 62.2% of the placebo group, 76.5% of the 5 mg group, and 74.4% of the 10 mg group. A drop of at least 100 points by week 8 was reported in 54.4% of the placebo group, 70.6% of the 5 mg group, and 68.6% of the 10 mg group. The average CDAI scores at week 8 were reported as approximately 195 for the placebo group, 163 for the 5 mg group, 159 for the 10 mg group, and 172 for the 15 mg group (though that last figure should be interpreted with caution given the very small group size). 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 28209624) ↗
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 2 Crohn's Disease and Colitis Trial, Completed
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 are between 18 and 75 years old (note: the upper age limit is 64 in India and 65 in the Netherlands)
- You have been diagnosed with Crohn's disease for at least 6 months before the screening visit
- Your Crohn's disease is currently moderately to severely active, affecting the small intestine, large intestine, or both, as measured by a standard scoring system called the CDAI (confirm with trial site)
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 been diagnosed with a different type of bowel disease, such as ulcerative colitis or indeterminate colitis, or have symptoms that suggest you may have ulcerative colitis
- You have Crohn's disease but have never received any treatment for it before
- You have taken certain immune-suppressing medications called azathioprine, 6-mercaptopurine, or methotrexate within the past 2 weeks
- You have received a type of treatment called anti-TNFα therapy (a specific kind of medication that targets inflammation) within the past 8 weeks
- You have received interferon therapy within the past 8 weeks
- You have taken certain other immune-suppressing medicines (cyclosporine, mycophenolate, or tacrolimus) within the past 4 weeks
- You have received corticosteroids given directly into a vein (by IV) within the past 2 weeks
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.
Trial contact details on record
Principal Investigator: Pfizer CT.gov Call Center, Pfizer
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 3 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8
Other options
Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.