Phase 3 Ankylosing Spondylitis Trial, Completed (NCT01583374)

Phase 3 Ankylosing Spondylitis Trial, Completed NCT01583374 Sponsor: Amgen Condition: Ankylosing Spondylitis

Printed from Voxsanity (voxsanity.com.au) — NCT01583374 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Ankylosing Spondylitis

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 (NCT01583374) looked at a medicine called apremilast in people with ankylosing spondylitis, a type of inflammatory arthritis affecting the spine. A total of 490 people took part in the first phase of the trial, split across three groups: 164 received a placebo (a dummy pill with no active ingredient), 163 received apremilast at a lower dose (20 mg), and 163 received apremilast at a higher dose (30 mg). The main thing the trial was measuring was how many people in each group showed a meaningful improvement — at least 20% better — across four areas: overall disease activity, back pain, physical function, and morning stiffness. This was assessed at Week 16. The reported data shows that at Week 16, approximately 36.6% of people in the placebo group, 35.0% in the apremilast 20 mg group, and 32.5% in the apremilast 30 mg group met that improvement threshold. For the secondary measures reported at Week 24, the numbers were similarly close across all three groups. For example, the percentage of people meeting the same improvement threshold at Week 24 was reported as 31.7% (placebo), 36.2% (apremilast 20 mg), and 33.7% (apremilast 30 mg). Changes in physical function scores, disease activity scores, and quality-of-life scores were also small and broadly similar across all three groups at Week 24. 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 33589554) ↗

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.

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 must have a confirmed diagnosis of ankylosing spondylitis (AS), a type of inflammatory arthritis affecting the spine, with back pain and stiffness that has lasted more than 3 months, gets better with movement, but does not go away with rest.
Your AS must be confirmed as "definite and active" using a specific set of criteria (called the modified New York criteria, 1984), which requires both an X-ray finding and at least one physical symptom to be present (confirm with trial site).
Your AS disease activity score (measured by a questionnaire called the BASDAI) must be 4 or higher out of 10, indicating a moderate to high level of disease activity.
Your total back pain score must be 4 or higher out of 10.
You must be on a stable dose of your current AS medication — or no medication at all — before joining the trial and continuing through the first 24 weeks.

Who may not be able to join:

You have previously been treated with a TNF blocker (a type of medication that targets inflammation, such as adalimumab or etanercept) or any other biologic treatment for AS.

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: MD, Amgen

Australian sites

Southern Clinical Research, Hobart, Tasmania

Emeritus Research, Camberwell, Victoria

Coastal Joint Care, Maroochydore,

Royal Perth Hospital, Perth,

The Queen Elizabeth Hospital, Woodville South,

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT01583374

Sponsor: Amgen

Phase: Phase 3

Status: Completed

Condition: Ankylosing Spondylitis

More information: https://clinicaltrials.gov/study/NCT01583374

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

"Who might be able to join this trial:

You must have a confirmed diagnosis of ankylosing spondylitis (AS), a type of inflammatory arthritis affecting the spine, with back pain and stiffness that has lasted more than 3 months, gets better with movement, but does not go away with rest.
Your AS must be confirmed as "definite and active" using a specific set of criteria (called the modified New York criteria, 1984), which requires both an X-ray finding and at least one physical symptom to be present (confirm with trial site).
Your AS disease activity score (measured by a questionnaire called the BASDAI) must be 4 or higher out of 10, indicating a moderate to high level of disease activity.
Your total back pain score must be 4 or higher out of 10.
You must be on a stable dose of your current AS medication — or no medication at all — before joining the trial and continuing through the first 24 weeks.

Who may not be able to join:

You have previously been treated with a TNF blocker (a type of medication that targets inflammation, such as adalimumab or etanercept) or any other biologic treatment for AS.

Important: Always verify eligibility with the trial site directly before applying."

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Completed

Phase

Phase 3

Sponsor

Amgen

Registry

ClinicalTrials.gov

Start date

2 May 2012

Est. completion

24 February 2014

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇸🇰 Slovakia 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society 20 (ASAS 20) Response at Week 16

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov