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 (NCT04169373) investigated a medicine called upadacitinib (15 mg daily) in people with axial spondyloarthritis — a type of inflammatory condition that mainly affects the spine and joints. The trial was made up of two separate studies running alongside each other. In Study 1, 209 people received a placebo (a dummy pill) and 211 received upadacitinib. In Study 2, 158 received placebo and 156 received upadacitinib. After the first blinded phase, participants moved into an open-label phase (where everyone received the active medicine) and, for some, a later withdrawal phase to see what happened when the medicine was stopped. In total, several hundred participants were involved across all phases of the trial. The reported data shows that the main thing being measured at 14 weeks was the proportion of participants who achieved a substantial improvement on a standardised scoring system called ASAS40 — broadly, this means noticeably better scores across several areas including back pain, physical function, morning stiffness, and the person's own rating of their disease. In Study 1, 44.5% of those taking upadacitinib reached this threshold, compared with 18.2% of those taking placebo. In Study 2, the reported figures were 44.9% for upadacitinib and 22.5% for placebo. Secondary measures also reported in the data — including changes in a disease activity score called ASDAS, MRI spine inflammation scores, and another symptom scale called BASDAI 50 — all showed larger numerical changes in the upadacitinib groups compared with placebo groups at 14 weeks. For example, in Study 1 the ASDAS score (where a bigger drop means less disease activity) changed by −1.52 in the upadacitinib group versus −0.49 in the placebo group, and 43.1% of the upadacitinib group reached the BASDAI 50 improvement threshold compared with 16.7% in the placebo group. 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 41824252) ↗
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:
For Study 1 (Ankylosing Spondylitis):
- You must have been diagnosed with ankylosing spondylitis (AS) and meet specific standard medical criteria for this condition.
- Your spine must not be completely fused/locked together from the disease.
- You must have previously tried 1 or 2 biologic medications (at least one from a specific group called TNF inhibitors or IL-17 inhibitors), and stopped because they didn't work well enough or caused side effects you couldn't tolerate.
For Study 2 (Non-radiographic axial spondyloarthritis):
- You must have been diagnosed with a related condition called non-radiographic axial spondyloarthritis (nr-axSpA), meaning you have the condition but it doesn't yet show up on X-rays in a specific way.
- You must have signs of active inflammation visible on an MRI scan of your lower back/pelvis joints, or shown through a specific blood test result.
- You may have previously tried at most one biologic medication and stopped due to it not working or causing intolerance (confirm with trial site for exact eligibility proportions).
For Both Studies:
- Your disease activity score (a standard questionnaire) must be 4 or higher at your screening and first visits.
- Your back pain level must be rated 4 or higher on a scale of 0–10 at your screening and first visits.
- Standard anti-inflammatory pain medications (NSAIDs) must not have worked well enough for you after at least 4 weeks at the highest dose you could tolerate, or you are unable to take NSAIDs due to intolerance or a medical reason.
Who may not be able to join:
- You must not have previously taken any JAK inhibitor medications, including upadacitinib (Rinvoq®), tofacitinib (Xeljanz®), baricitinib (Olumiant®), filgotinib, ruxolitinib (Jakafi®), abrocitinib, or peficitinib.
- Any previous biologic medication must have been stopped for a required period of time before joining the trial (confirm the exact timeframe with the trial site).
- You must not have a history of allergic reactions or significant sensitivities to any ingredients in the study drug.
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: ABBVIE INC., AbbVie
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
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Study 1: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society 40 (ASAS40) Response at Week 14; Study 2: Percentage of Participants Achieving an ASAS40 Response at Week 14
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.