Phase 3 Psoriatic Arthritis Trial, Completed NCT01690299 Sponsor: Amgen Condition: Psoriatic Arthritis
Back to Psoriatic Arthritis

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 enrolled 250 adults with psoriasis across three groups during the first phase (weeks 0 to 16): 84 people received a placebo (a dummy treatment), 83 received apremilast (a tablet), and 83 received etanercept (an injection). The trial was primarily measuring how many participants had their psoriasis severity score — called a PASI score, which rates redness, thickness, scaling and the area of skin affected on a scale from 0 to 72 — reduce by at least 75% after 16 weeks. After this first phase, participants moved into a longer extension phase running to about two years, where all groups received apremilast, with roughly 73–80 people starting in each of the three carry-over groups. The reported data shows that, at the 16-week mark, 39.8% of people in the apremilast group and 48.2% of people in the etanercept group reached that 75% improvement threshold in their PASI score, compared with 11.9% in the placebo group. For a less strict measure — a 50% improvement in PASI score — the reported figures were 62.7% for apremilast and 83.1% for etanercept, versus 33.3% for placebo. When doctors rated overall skin clearance on a 0–4 scale (where 0 is clear and 4 is severe), 21.7% of apremilast participants and 28.9% of etanercept participants were rated as clear or almost clear, compared with 3.6% on placebo. The reported data also shows that the affected body surface area changed by an average of −47.7% in the apremilast group and −56.1% in the etanercept group, versus −16.3% in the placebo group. On a quality-of-life questionnaire scored from 0 (best) to 30 (worst), average scores changed by −8.4 points for apremilast, −7.8 for etanercept, and −3.9 for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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 Psoriatic Arthritis Trial, Completed

NCT01690299
Completed Phase 3 🇦🇺 Australian site

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 moderate to severe plaque psoriasis for at least 12 months before screening, and you are a suitable candidate for light therapy or systemic (whole-body) treatments
  • You have previously tried at least one standard systemic (whole-body) treatment for psoriasis but it did not work well enough, you could not tolerate it, or you were unable to use it for medical reasons
  • You have never been treated with biologic medications for psoriasis or psoriatic arthritis

Who may not be able to join:

  • You have a significant uncontrolled health condition (other than psoriasis), or a condition that would make it unsafe for you to take part (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have already tried and failed more than 3 systemic (whole-body) treatments for psoriasis
  • You have a known allergy to any ingredient in the study drug, including human immunoglobulin proteins, or to etanercept
  • You tested positive for Hepatitis B or Hepatitis C at your screening appointment
  • You have active, latent, or inadequately treated tuberculosis, or certain other serious infections (confirm with trial site)
  • You have a history of, or currently have, a long-term or recurring infectious disease
  • You have received, or are expected to receive, a live virus or bacterial vaccine within 3 months before starting the study, or during the first 20 weeks of the study
  • You received a BCG vaccine (a type of tuberculosis vaccine) within 1 year before screening
  • You have tested positive for HIV, or you have an immune system deficiency, whether present from birth or developed over time
  • You are currently misusing substances or have done so within the 6 months before screening
  • You have or have had cancer, except for certain treated skin cancers or cervical conditions with no signs of return in the past 5 years (confirm with trial site)
  • Your psoriasis has suddenly flared or rebounded within 4 weeks before screening
  • You have used a topical (skin-applied) psoriasis treatment within 2 weeks, or a systemic (whole-body) psoriasis treatment within 4 weeks, before being enrolled in the study
  • You have used light therapy, had prolonged sun exposure, or used tanning beds or other UV light sources within 4 weeks before being enrolled
  • You have taken part in another clinical trial or used an experimental drug within 4 weeks before being enrolled (or longer, depending on the drug)
  • You have previously been treated with apremilast or etanercept

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 27 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

The Skin Centre, Benowa, Queensland
Sinclair Dermatology, East Melbourne, Victoria
Fremantle Dermatology, Fremantle, Western Australia
Gairdner Hospital, Victoria Park,
Rheumatology unit Ward 5C Queen Elizabeth Hospital, Woodville,
Veracity Clinical Research, Woolloongabba,

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

Status
Completed
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2012
Est. completion
3 July 2014

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇪🇪 Estonia 🇩🇪 Germany 🇭🇺 Hungary 🇱🇻 Latvia 🇳🇱 Netherlands 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Percentage of Participants Who Achieved a 75% Improvement (Response) in the Psoriasis Area Severity Index (PASI-75) for the Comparison Between Apremilast and Placebo at Week 16 From Baseline

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: 27 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