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 (NCT01393899) enrolled 180 people with Crohn's disease — a condition causing ongoing inflammation in the digestive tract. Participants were divided into three groups: 59 received a placebo (a dummy treatment with no active ingredient), 60 received a lower dose of tofacitinib (5 mg twice daily), and 61 received a higher dose (10 mg twice daily). The trial ran for 26 weeks and was measuring how many people either showed a meaningful improvement in their disease activity score — using a standard tool called the Crohn's Disease Activity Index (CDAI), which rates symptoms on a scale from 0 to around 600 — or reached a point considered "remission" (a score below 150, meaning very low disease activity). It is worth noting that a notable number of participants did not complete the study: 32 in the placebo group, 28 in the lower-dose group, and 23 in the higher-dose group did not finish. The reported data shows that at the main 26-week check-in, the percentage of participants who had either improved their score by at least 100 points or were in remission was 38.1% in the placebo group, 39.5% in the lower-dose tofacitinib group, and 55.8% in the higher-dose tofacitinib group. For remission specifically at week 26, the reported figures were 31.0% (placebo), 32.6% (lower dose), and 39.5% (higher dose). The reported data also shows that for "sustained remission" — meaning participants were in remission at both the week 20 and week 26 check-ins — the figures were 21.4% (placebo), 23.3% (lower dose), and 39.5% (higher dose). Earlier time points (weeks 4, 8, 12, and 20) showed varying percentages across all three groups, with results shifting up and down over the course of the study across all groups including placebo. 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
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 have already taken part in a related study called A3921083 and completed your visit at Week 8 of that study.
- Your Crohn's disease symptoms must have improved significantly or gone into remission (very low disease activity) during the A3921083 study, based on a standard scoring system called the CDAI.
- If you are a woman who could become pregnant, you must have a negative pregnancy test before joining this trial.
Who may not be able to join:
- If you seriously broke any of the rules of the previous A3921083 study, as decided by the study organisers, you may not be eligible.
- If it is likely that you will need any kind of surgery during the time the trial is running, you may not be able to take part.
- If a stool (poo) test shows that you have an active infection caused by harmful bacteria or toxins, you may not be eligible.
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 Clinical Response-100 (as Defined by a Decrease in Crohn's Disease Activity Index [CDAI] Score of at Least 100 Points From Baseline) or Clinical Remission (CDAI Score Less Than [<]150) at Week 26
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.