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 (NCT01209702) involved people with ankylosing spondylitis — a type of inflammatory arthritis mainly affecting the spine. A total of 306 participants took part across two parts of the study. In Part 1, 51 people received a placebo (an inactive treatment) and 51 received tocilizumab. In Part 2, 51 received a placebo and 153 received tocilizumab. The trial was measuring whether tocilizumab led to meaningful improvements in participants' symptoms, including pain, physical function, morning stiffness, and their overall sense of how their condition was affecting them. The reported data shows that the main goal of the trial — known as the primary outcome — was to look at the percentage of participants who achieved at least a 20% improvement across several symptom areas by week 12 (this is called an ASAS20 response). In Part 1, 37.3% of those who received tocilizumab and 27.5% of those who received the placebo reached this level of improvement. For a stricter measure of improvement (40% across symptom areas, or ASAS40) at week 12, the reported figures were 11.8% for the tocilizumab group and 19.6% for the placebo group. The reported data also shows that in Part 2 at week 24, 0% of participants in both the placebo and tocilizumab groups met the ASAS20 response threshold, though it is worth noting that very few participants remained in Part 2 at that stage. For a measure of disease activity called the BASDAI score (rated 0–10, where lower is better), both groups started with scores around 6.4–6.9, and both showed modest reductions by the end of their respective treatment periods; the changes reported ranged from approximately –0.53 to –1.17 across the 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 23765873) ↗
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 are 18 years of age or older
- You have been diagnosed with Ankylosing Spondylitis (a type of spinal arthritis) for at least 3 months before the study start date, based on specific medical criteria
- Your condition is currently active, meaning your symptoms and spinal pain scores are above certain levels at the time of screening and at the start of the study
- You have not responded well to, or could not tolerate, at least one type of common anti-inflammatory painkiller (such as ibuprofen or naproxen)
- Certain arthritis medications (like methotrexate, sulfasalazine, or hydroxychloroquine) may be allowed if you have been on a stable dose for at least 4 weeks before the study starts
- If you take steroid tablets or anti-inflammatory painkillers, your dose must have been stable for at least 4 weeks before the study starts
Who may not be able to join:
- You have had major surgery (including joint surgery) in the 8 weeks before screening, or you are planning major surgery within 6 months of joining the study
- Your spine is completely fused/locked, as determined by the study doctor
- You have another type of inflammatory joint or rheumatic disease in addition to Ankylosing Spondylitis
- You have a current active eye inflammation (uveitis) at the start of the study
- You have ever been treated with a type of medication called a TNF antagonist (such as adalimumab or etanercept) at any point before joining the study
- You have had steroid injections into a joint or muscle, or any injections of steroids, within 4 weeks before screening
- You have a history of serious allergic or life-threatening reactions to certain types of biological medicines (confirm with trial site)
- You currently have or have a history of repeated bacterial, viral, fungal, or other infections
- You have a condition that weakens your immune system, either from birth or developed later in life
- Your body weight is more than 150 kg (approximately 330 lbs)
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: Clinical Trials, Hoffmann-La Roche
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
Part 1: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12; Part 2: Percentage of Participants Achieving a 20% Improvement in Assessment in Ankylosing Spondylitis (ASAS20) at Week 12
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.