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 looked at certolizumab pegol (CZP), a medication given by injection, in people with ankylosing spondylitis — a type of inflammatory arthritis affecting the spine. In the first part of the trial (weeks 0 to 52), 158 people received a placebo (a dummy treatment with no active ingredient) and 159 received CZP. After week 52, 243 participants moved into an open-label extension phase (meaning everyone knew they were receiving CZP) that ran through to week 156. The trial measured things like disease activity scores, pain, stiffness, and physical function using established rating scales, as well as the levels of CZP in participants' blood at various time points. The reported data shows that at week 52, around 47% of people in the CZP group met what is called a "major improvement" threshold on a disease activity score (meaning their score dropped by at least 2 points out of a possible 10-point range), compared with about 7% in the placebo group. Separately, at week 12, around 48% of people in the CZP group met a different response measure — which required improvements of at least 40% across several areas including pain, function, and global disease assessment — compared with about 11% in the placebo group. Regarding blood levels of CZP, the reported data shows concentrations of roughly 51 µg/mL at week 1, 36 µg/mL at week 2, and around 55 µg/mL (CZP group) and 49 µg/mL (placebo-to-CZP group) at week 4; baseline concentration data was not reported in the submitted results. 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 35296532) ↗
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 are at least 18 years old at the start of the screening process
- You have been diagnosed with a specific type of back-related arthritis called axial spondyloarthritis (axSpA), confirmed using recognised international guidelines
- You have had back pain for at least 12 months before the screening visit
- Your X-rays of the joints at the base of your spine (the sacroiliac joints) do not show a specific type of damage called sacroiliitis (confirm with trial site)
- Your condition is currently active, shown by specific scores on standard disease activity questionnaires — a BASDAI score of 4 or more, and a spinal pain score of at least 4 out of 10
- You have not responded well to, cannot take, or have had bad reactions to at least 2 anti-inflammatory painkillers (NSAIDs, such as ibuprofen or naproxen)
Who may not be able to join:
- You have been diagnosed with ankylosing spondylitis (AS) or any other type of inflammatory arthritis
- You have previously been treated with any experimental biological medicines for axial spondyloarthritis
- You have been treated with more than one TNF-blocker medication, or a TNF-blocker did not work for you at all
- You have a history of long-term or recurring infections
- You have tuberculosis (TB), are at high risk of getting TB, or have a latent (inactive) TB infection
- You have recently received a live vaccine (confirm with trial site for timing details)
- You currently have cancer, or have had cancer in the past
- You have severe heart failure (classified as Class III or IV)
- You have a disease affecting the protective coating of the nerves in your brain or spinal cord (such as multiple sclerosis)
- You are currently breastfeeding, pregnant, or planning to become pregnant during the study or within 3 months after the last dose of the trial medicine
- You have any other health condition that the trial doctor believes would make participation unsuitable for you
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: UCB Cares, 1-844-599-2273 (UCB)
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 Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52; Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12; Certolizumab Pegol Plasma Concentration at Baseline; Certolizumab Pegol Plasma Concentration at Week 1; Certolizumab Pegol Plasma Concentration at Week 2; Certolizumab Pegol Plasma Concentration at Week 4; Certolizumab Pegol Plasma Concentration at Week 12; Certolizumab Pegol Plasma Concentration at Week 24; Certolizumab Pegol Pla...
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.