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 (NCT01061723) enrolled 301 people with ankylosing spondylitis (a type of inflammatory spinal arthritis) across six groups. Fifty or so participants were assigned to each group: one group received a placebo (a dummy injection with no active medicine), and the other five received different doses and dosing schedules of a medicine called sarilumab. The trial ran for 12 weeks and was mainly measuring how many participants experienced a meaningful improvement in their symptoms — specifically a 20% reduction in scores across several areas including pain, physical function, and overall wellbeing. The reported data shows that for the primary measure — the proportion of people who met the 20% improvement threshold at week 12 — the placebo group came in at 24%, while the sarilumab groups ranged from about 19% (100 mg weekly) up to 38% (150 mg weekly). For a stricter 40% improvement threshold, the placebo group was at 8%, and the sarilumab groups ranged from roughly 6% to 20%. The reported data also shows that a small number of participants in each group reached what was defined as "partial remission" (very low scores across all four symptom areas), ranging from about 2% in several groups up to around 8% in two of the sarilumab groups and the 100 mg every-two-weeks group. On two additional scales measuring disease activity and physical function (the ASDAS and BASDAI scores, where lower numbers mean less disease activity), all groups — including placebo — showed some decrease from their starting scores over the 12 weeks, with the reported reductions in the sarilumab groups generally somewhat larger than in the placebo group. Changes in a measure of spinal movement (BASMI) were small and similar across all 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 24550171) ↗
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 2 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) using standard medical criteria known as the "New York modified criteria."
- You have tried at least 2 different anti-inflammatory pain medications (like ibuprofen or naproxen) for at least 2 weeks each, or you are unable to tolerate these types of medications.
- You have had active AS symptoms for at least 3 months before your screening appointment, and symptoms must still be active at the time of screening and the start of the trial.
- Your AS activity score (called BASDAI) is 4 or higher on a scale of 0–10 (confirm with trial site).
- Your back pain score is 4 or higher on a scale of 0–10.
- If you are taking steroid medications (corticosteroids), your dose has been stable for at least 2 weeks before the trial starts.
- If you are taking certain disease-modifying drugs (hydroxychloroquine, sulfasalazine, or methotrexate), your dose has been stable for at least 12 weeks before the trial starts.
Who may not be able to join:
- You are under 18 years old or 75 years old or older.
- Your spine has completely fused together.
- You have previously tried and not responded to anti-TNF treatments or other similar biologic medications for AS.
- You have used anti-TNF or any biologic treatment within the last 3 months before screening.
- You are currently taking disease-modifying drugs other than hydroxychloroquine, sulfasalazine, or methotrexate.
- You are taking methotrexate at a dose higher than 25 mg per week.
- You are taking hydroxychloroquine at a dose higher than 400 mg per day.
- You are taking sulfasalazine at a dose higher than 3 g per day.
- You have taken oral steroid tablets (such as prednisone) at more than 10 mg per day within the last 6 weeks before screening.
- You have received steroid injections into a muscle or joint within the last 4 weeks before screening.
- You have previously been treated with cyclosporine or azathioprine.
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 Sciences & Operations, Sanofi
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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.