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 (NCT03502616) looked at a medicine called tofacitinib in people with ankylosing spondylitis, a type of inflammatory back condition. A total of 270 people took part — 134 were assigned to receive tofacitinib and 136 were assigned to receive a placebo (a dummy treatment) first, before later switching to tofacitinib. The main thing the trial measured was whether participants reached a meaningful improvement in their disease activity by week 16, using a standard scoring system called ASAS20, which tracks back pain, physical function, morning stiffness, and overall disease activity. The reported data shows that at week 16, about 56% of participants in the tofacitinib group met the ASAS20 improvement threshold, compared with about 29% in the placebo group. For a stricter improvement target (called ASAS40, meaning a larger improvement across the same areas), the reported figures were about 41% in the tofacitinib group and about 13% in the placebo group. Regarding adverse events (unexpected medical occurrences recorded during the study), the reported data shows that 73 participants in the tofacitinib group and 70 in the placebo group experienced at least one such event up to week 16; across the full 48-week period, those numbers rose to 103 and 93 respectively. No participants in either group were reported to have met the criteria for abnormal vital signs such as pulse rate or blood pressure in most categories, though small numbers had some variations noted. 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 41039829) ↗
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 Ankylosing Spondylitis 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 have been diagnosed with Ankylosing Spondylitis (AS) based on specific diagnostic guidelines called the Modified New York Criteria (1984).
- You have had an X-ray of your pelvis that confirms your diagnosis of AS.
- Your AS is still causing significant symptoms even while taking anti-inflammatory pain medications (such as ibuprofen or naproxen), or you are unable to take those medications due to side effects.
Who may not be able to join:
- You have a history of, or are suspected to have, complete fusion/locking of the spine.
- You have a known allergy, intolerance, or sensitivity to lactose (a sugar found in dairy products) or to the drug tofacitinib.
- You have been diagnosed with any other condition affecting the joints or connective tissues (such as rheumatoid arthritis or lupus).
- You have any condition that affects how your body absorbs medications taken by mouth (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
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16
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.