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 (NCT02407223) enrolled 356 people with ankylosing spondylitis (a type of inflammatory spinal arthritis) across three groups: 116 received a placebo (an inactive treatment), 118 received ustekinumab at a 45 mg dose, and 122 received ustekinumab at a 90 mg dose. The trial was measuring how participants responded to treatment at 24 weeks using several standardised scoring tools that assess things like back pain, physical function, morning stiffness, and overall disease activity. It is worth noting that the data shows no participants were recorded as having formally "completed" the study under that milestone category, which may reflect how the trial's design tracked participants through different phases such as early escape and crossover points. The reported data shows that for the main outcome — the proportion of participants achieving a meaningful improvement on a standard disease activity score (called ASAS 20, which measures at least a 20% improvement across several symptom areas) — the figures at week 24 were 47.6% in the placebo group, 55.4% in the ustekinumab 45 mg group, and 49.4% in the ustekinumab 90 mg group. For a higher level of improvement (ASAS 40, meaning at least 40% improvement), the reported figures were 25.6%, 33.7%, and 28.2% respectively. The proportion of participants reaching a disease activity score considered "inactive" was reported as 7.3% (placebo), 14.5% (45 mg), and 12.9% (90 mg). The reported data also shows that on a measure of physical function (the BASFI scale, where lower numbers indicate fewer limitations), all three groups showed a reduction from their starting scores at week 24: −2.11 for placebo, −2.28 for the 45 mg group, and −1.90 for the 90 mg group. A blood marker of inflammation (high-sensitivity C-reactive protein) also showed reductions across all groups over the 24 weeks, with the largest reductions reported in the ustekinumab groups. 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 30225992) ↗
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, Terminated
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 a condition called non-radiographic axial spondyloarthritis (nr-AxSpA) based on specific international guidelines (confirm with trial site)
- Your symptoms of nr-AxSpA first appeared when you were 45 years old or younger
- An MRI scan shows active inflammation in your lower back/pelvis area, and an X-ray does not show a specific level of joint damage in the sacroiliac joints (the joints connecting your spine to your pelvis)
- You are currently experiencing active, significant symptoms, shown by scoring 4 or higher (out of 10) on two standard pain and disease activity questionnaires
Who may not be able to join:
- Your X-rays show a specific level of damage to the sacroiliac joints that meets a particular medical standard (the 1984 modified New York Criteria)
- You have other inflammatory diseases that could make it hard to tell whether the study treatment is working
- You have taken certain immune-suppressing or disease-modifying medications (other than methotrexate, sulfasalazine, or hydroxychloroquine) in the 4 weeks before starting the study
- You have received steroid injections or infusions (into a joint, muscle, vein, or spine) in the 4 weeks before starting the study
- You have previously been treated with a type of medication called a "biologic," unless it was an anti-TNFα therapy
- You have previously been treated with more than one anti-TNFα medication
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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
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
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
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.